Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Rate of Decline of Lung Function With Tiotropium 18 mcg Inhalation Capsule Once Daily in Patients With Chronic Obstructive Pulmonary Disease (COPD).
| NCT number | NCT00144339 |
| Other study ID # | 205.235 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | September 2, 2005 |
| Last updated | May 15, 2014 |
| Start date | December 2002 |
The primary objective of this trial is to determine whether daily treatment with tiotropium (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of decline in lung function over time in patients with COPD.
| Status | Completed |
| Enrollment | 5993 |
| Est. completion date | |
| Est. primary completion date | February 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
Inclusion Criteria: - Written informed consent. - Male or female patients 40 years of age or older. - Smoking history of at least 10 pack years. - Diagnosis of COPD with post bronchodilator FEV1 less than or equal to 70% of predicted normal and FEV1<70% of FVC and on stable respiratory medication. Exclusion Criteria: - Significant diseases other than COPD which in the opinion of the investigator may put the patient at risk or influence the patients ability to participate. - Myocardial infarction in past 6 months. - Unstable or life threatening arrhythmia in past year. - Hospitalization for NYHA heart failure class III or IV in past year. - Active tuberculosis. - Asthma. - Pulmonary resection. - Malignancy treated with radiation or chemotherapy in past 5 years. - Respiratory infection in 4 weeks prior to screening. - Known hypersensitivity to anticholinergic drugs or components. - Known moderate to severe renal impairment. - Known narrow angle glaucoma. - Significant symptomatic BPH or bladder neck obstruction. - Need for oxygen therapy >12 hr/day. - Use of oral corticosteroids at unstable doses or >10 mg/day. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | 205.235.101 | Buenos Aires | |
| Argentina | 205.235.101 Boehringer Ingelheim Investigational Site | Capital Federal | |
| Argentina | 205.235.103 Hospital Alemán | Capital Federal | |
| Argentina | 205.235.104 Hospital de Clinicas José de San Martín | Capital Federal | |
| Argentina | 205.235.105 Hospital General de Agudos José María Ramos Mejía | Capital Federal | |
| Argentina | 205.235.107 Policlínica Bancaria | Capital Federal | |
| Argentina | 205.235.108 Hospital General de Agudos Dr. Enrique Tornú | Capital Federal | |
| Argentina | 205.235.109 Hospital Muñiz | Capital Federal | |
| Argentina | 205.235.110 Hospital Privado - Centro Médico de Córdoba S.A. | Parque Velez Sarlfield | |
| Argentina | 205.235.102 Instituto Cardiovascular de Rosario | Rosario | |
| Argentina | 205.235.106 Hospital Cetrángolo | Vicente López | |
| Australia | 205.235.0205 Boehringer Ingelheim Investigational Site | Bankstown | New South Wales |
| Australia | 205.235.0206 Boehringer Ingelheim Investigational Site | Box Hill | Victoria |
| Australia | 205.235.0204 Boehringer Ingelheim Investigational Site | Cairns | Queensland |
| Australia | 205.235.0202 Boehringer Ingelheim Investigational Site | Concord | New South Wales |
| Australia | 205.235.0201 Boehringer Ingelheim Investigational Site | Geelong | Victoria |
| Australia | 205.235.0207 Boehringer Ingelheim Investigational Site | Port Lincoln | South Australia |
| Australia | 205.235.0203 Boehringer Ingelheim Investigational Site | Redcliffe | Queensland |
| Australia | 205.235.0209 Boehringer Ingelheim Investigational Site | Westmead | New South Wales |
| Austria | 205.235.0303 Boehringer Ingelheim Investigational Site | Graz | |
| Austria | 205.235.0305 Boehringer Ingelheim Investigational Site | Innsbruck | |
| Austria | 205.235.0304 Boehringer Ingelheim Investigational Site | Leoben | |
| Austria | 205.235.0301 Boehringer Ingelheim Investigational Site | Wien | |
| Austria | 205.235.0302 Boehringer Ingelheim Investigational Site | Wien | |
| Belgium | 205.235.0439 Boehringer Ingelheim Investigational Site | Anderlecht | |
| Belgium | 205.235.0429 Boehringer Ingelheim Investigational Site | Baudour | |
| Belgium | 205.235.0421 Boehringer Ingelheim Investigational Site | Brugge | |
| Belgium | 205.235.0424 Boehringer Ingelheim Investigational Site | Brussel | |
| Belgium | 205.235.0432 Boehringer Ingelheim Investigational Site | Bruxelles | |
| Belgium | 205.235.0434 Boehringer Ingelheim Investigational Site | Bruxelles | |
| Belgium | 205.235.0422 Boehringer Ingelheim Investigational Site | Dendermonde | |
| Belgium | 205.235.0405 Boehringer Ingelheim Investigational Site | Edegem | |
| Belgium | 205.235.0414 Boehringer Ingelheim Investigational Site | Gent | |
| Belgium | 205.235.0418 U.Z. Gent | Gent | |
| Belgium | 205.235.0417 Boehringer Ingelheim Investigational Site | Herentals | |
| Belgium | 205.235.0402 Boehringer Ingelheim Investigational Site | Ieper | |
| Belgium | 205.235.0409 Boehringer Ingelheim Investigational Site | Kortrijk | |
| Belgium | 205.235.0407 Boehringer Ingelheim Investigational Site | Leuven | |
| Belgium | 205.235.0440 Boehringer Ingelheim Investigational Site | Luxembourg | |
| Belgium | 205.235.0403 Boehringer Ingelheim Investigational Site | Menen | |
| Belgium | 205.235.0406 Boehringer Ingelheim Investigational Site | Merksem | |
| Belgium | 205.235.0404 Boehringer Ingelheim Investigational Site | Middelheim | |
| Belgium | 205.235.0438 Boehringer Ingelheim Investigational Site | Mons | |
| Belgium | 205.235.0437 Boehringer Ingelheim Investigational Site | Namur | |
| Belgium | 205.235.0420 Boehringer Ingelheim Investigational Site | Neerpelt | |
| Belgium | 205.235.0435 Boehringer Ingelheim Investigational Site | Nobressart (ATTERT) | |
| Belgium | 205.235.0423 Boehringer Ingelheim Investigational Site | Oostende | |
| Belgium | 205.235.0433 Boehringer Ingelheim Investigational Site | Tournai | |
| Belgium | 205.235.0412 Boehringer Ingelheim Investigational Site | Turnhout | |
| Belgium | 205.235.0413 Boehringer Ingelheim Investigational Site | Turnhout | |
| Belgium | 205.235.0428 Boehringer Ingelheim Investigational Site | Yvoir | |
| Brazil | 205.235.510 Servico de Pneumologia | Florianópolis - SC | |
| Brazil | 205.235.508 | Juiz de Fora - MG | |
| Brazil | 205.235.501 | Porto Alegre - RS | |
| Brazil | 205.235.503 | Porto Alegre - RS | |
| Brazil | 205.235.506 | Porto Alegre - RS | |
| Brazil | 205.235.507 Depto.de Medicina Interna-Servico de pneumologia | Porto Alegre - RS | |
| Brazil | 205.235.502 | Rio de Janeiro - RJ | |
| Brazil | 205.235.505 Dep.Medicina Especializada (DEMESP) | Rio de Janeiro - RJ | |
| Brazil | 205.235.511 Departamento de Pneumologia | Salvador - BA | |
| Brazil | 205.235.504 ANEXO 2-Laboratório de Funcao Pulmonar | Santo André - SP | |
| Brazil | 205.235.512 | São Paulo - SP | |
| Brazil | 205.235.513 | São Paulo - SP | |
| Brazil | 205.235.514 Unidade de Coracao e Pulmao do Dto. de Medicina | São Paulo - SP | |
| Brazil | 205.235.515 Lar Escola São Francisco / Setor de Pneumologia | São Paulo - SP | |
| Czech Republic | 205.235.0712 Boehringer Ingelheim Investigational Site | Benesov | |
| Czech Republic | 205.235.0711 Boehringer Ingelheim Investigational Site | Beroun | |
| Czech Republic | 205.235.0718 Clinic of Functional Diagnostics and Rehabilitation | Brno | |
| Czech Republic | 205.235.0725 University Hospital Brno | Brno | |
| Czech Republic | 205.235.0720 Office of Pulmonology and Respiratory Diseases | Cesky Tesin | |
| Czech Republic | 205.235.0717 Pulmonary Clinic | Hradec Kralove | |
| Czech Republic | 205.235.0705 Boehringer Ingelheim Investigational Site | Jablonec nad Nisou | |
| Czech Republic | 205.235.0726 Private Office of Pulmonary Diseases | Jaromer | |
| Czech Republic | 205.235.0722 Hospital Kromeriz | Kromeriz | |
| Czech Republic | 205.235.0724 District Hospital Kyjov | Kyjov | |
| Czech Republic | 205.235.0704 Boehringer Ingelheim Investigational Site | Lovosice | |
| Czech Republic | 205.235.0702 Boehringer Ingelheim Investigational Site | Marianske Lazne | |
| Czech Republic | 205.235.0701 Boehringer Ingelheim Investigational Site | Plzen | |
| Czech Republic | 205.235.0703 Boehringer Ingelheim Investigational Site | Plzen | |
| Czech Republic | 205.235.0710 Boehringer Ingelheim Investigational Site | Prague 5 | |
| Czech Republic | 205.235.0706 Boehringer Ingelheim Investigational Site | Praha 4 | |
| Czech Republic | 205.235.0709 Boehringer Ingelheim Investigational Site | Praha 4 | |
| Czech Republic | 205.235.0715 Boehringer Ingelheim Investigational Site | Praha 5 | |
| Czech Republic | 205.235.0708 Boehringer Ingelheim Investigational Site | Praha 5 - Nove Butovice | |
| Czech Republic | 205.235.0707 Boehringer Ingelheim Investigational Site | Praha 8 | |
| Czech Republic | 205.235.0723 Office of Pulmonary and Respiratory Diseases | Prerov | |
| Czech Republic | 205.235.0721 Office of Pulmonary Diseases | Pribor | |
| Czech Republic | 205.235.0713 Boehringer Ingelheim Investigational Site | Strakonice | |
| Czech Republic | 205.235.0714 Boehringer Ingelheim Investigational Site | Tabor | |
| Czech Republic | 205.235.0719 Office of Pulmonology and Respiratory Diseases | Usti nad Orlici | |
| Czech Republic | 205.235.0716 Boehringer Ingelheim Investigational Site | Znojmo | |
| Denmark | 205.235.0804 Boehringer Ingelheim Investigational Site | Aalborg | |
| Denmark | 205.235.0826 Boehringer Ingelheim Investigational Site | Aalborg SV | |
| Denmark | 205.235.0803 Boehringer Ingelheim Investigational Site | Aarhus | |
| Denmark | 205.235.0831 Boehringer Ingelheim Investigational Site | Copenhagen | |
| Denmark | 205.235.0828 Boehringer Ingelheim Investigational Site | Copenhagen K | |
| Denmark | 205.235.0802 Boehringer Ingelheim Investigational Site | Copenhagen NV | |
| Denmark | 205.235.0807 Boehringer Ingelheim Investigational Site | Fåborg | |
| Denmark | 205.235.0821 Boehringer Ingelheim Investigational Site | Frederikshavn | |
| Denmark | 205.235.0832 Boehringer Ingelheim Investigational Site | Frederikssund | |
| Denmark | 205.235.0805 Boehringer Ingelheim Investigational Site | Hellerup | |
| Denmark | 205.235.0835 Boehringer Ingelheim Investigational Site | Hellerup | |
| Denmark | 205.235.0816 Boehringer Ingelheim Investigational Site | Helsingor | |
| Denmark | 205.235.0811 Boehringer Ingelheim Investigational Site | Hillerød | |
| Denmark | 205.235.0834 Boehringer Ingelheim Investigational Site | Hobro | |
| Denmark | 205.235.0806 Boehringer Ingelheim Investigational Site | Holbæk | |
| Denmark | 205.235.0814 Boehringer Ingelheim Investigational Site | Holstebro | |
| Denmark | 205.235.0801 Boehringer Ingelheim Investigational Site | Hvidovre | |
| Denmark | 205.235.0833 Boehringer Ingelheim Investigational Site | Kalundborg | |
| Denmark | 205.235.0830 Boehringer Ingelheim Investigational Site | Kolding | |
| Denmark | 205.235.0810 Boehringer Ingelheim Investigational Site | Næstved | |
| Denmark | 205.235.0819 Boehringer Ingelheim Investigational Site | Nykobing F. | |
| Denmark | 205.235.0809 Boehringer Ingelheim Investigational Site | Odense C | |
| Denmark | 205.235.0815 Boehringer Ingelheim Investigational Site | Randers | |
| Denmark | 205.235.0824 Boehringer Ingelheim Investigational Site | Silkeborg | |
| Denmark | 205.235.0813 Boehringer Ingelheim Investigational Site | Skive | |
| Denmark | 205.235.0822 Boehringer Ingelheim Investigational Site | Skive | |
| Denmark | 205.235.0820 Boehringer Ingelheim Investigational Site | Slagelse | |
| Denmark | 205.235.0808 Boehringer Ingelheim Investigational Site | Svendborg | |
| Denmark | 205.235.0827 Boehringer Ingelheim Investigational Site | Værløse | |
| Finland | 205.235.0903 Boehringer Ingelheim Investigational Site | Helsinki | |
| Finland | 205.235.0901 Boehringer Ingelheim Investigational Site | Jyväskylä | |
| Finland | 205.235.0905 Boehringer Ingelheim Investigational Site | Kotka | |
| Finland | 205.235.0904 Boehringer Ingelheim Investigational Site | Lahti | |
| Finland | 205.235.0902 Boehringer Ingelheim Investigational Site | Pori | |
| France | 205.235.1007 Cabinet Médical | Albi | |
| France | 205.235.1004 Clinique Toulouse Lautrec | Albi cedex 9 | |
| France | 205.235.1015 Centre Hospitalier | Barbezieux St Hilaire | |
| France | 205.235.1012 Cabinet Médical | Bourges | |
| France | 205.235.1024 Cabinet Médical | Chamalières | |
| France | 205.235.1006 Centre Hospitalier de Chauny | Chauny cedex | |
| France | 205.235.1005 Polyclinique | Cholet | |
| France | 205.235.1013 Cabinet Médical | La Teste | |
| France | 205.235.1020 Cabinet Médical | Marseille | |
| France | 205.235.1023 Cabinet Médical | Montauban | |
| France | 205.235.1025 Centre Médical Erdre Saint Augustin | Nantes | |
| France | 205.235.1002 Cabinet médical | Nice | |
| France | 205.235.1001 Hôpital Bichat | Paris | |
| France | 205.235.1016 Cabinet Médical | Provins | |
| France | 205.235.1019 Cabinet Médical | Strasbourg | |
| France | 205.235.1009 Centre Hospitalier de Bigorre | Tarbes cedex 9 | |
| France | 205.235.1021 Clinique Pasteur | Toulouse | |
| Germany | 205.235.1113 Boehringer Ingelheim Investigational Site | Berlin | |
| Germany | 205.235.1114 Boehringer Ingelheim Investigational Site | Berlin | |
| Germany | 205.235.1103 Boehringer Ingelheim Investigational Site | Brake | |
| Germany | 205.235.1105 Boehringer Ingelheim Investigational Site | Braunschweig | |
| Germany | 205.235.1104 Boehringer Ingelheim Investigational Site | Bruchsal | |
| Germany | 205.235.1115 Boehringer Ingelheim Investigational Site | Hannover | |
| Germany | 205.235.1109 Boehringer Ingelheim Investigational Site | Kaufbeuren | |
| Germany | 205.235.1108 Boehringer Ingelheim Investigational Site | Lörrach | |
| Germany | 205.235.1102 Boehringer Ingelheim Investigational Site | Lübeck | |
| Germany | 205.235.1106 Boehringer Ingelheim Investigational Site | München | |
| Germany | 205.235.1110 Boehringer Ingelheim Investigational Site | München | |
| Germany | 205.235.1101 Boehringer Ingelheim Investigational Site | Ulm | |
| Germany | 205.235.1107 Boehringer Ingelheim Investigational Site | Weyhe | |
| Germany | 205.235.1112 Boehringer Ingelheim Investigational Site | Wiesloch | |
| Greece | 205.235.1202 8th Pulmonology Clinic "Sotiria" Athens Chest Hospital | Athens | |
| Greece | 205.235.1203 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 205.235.1201 Boehringer Ingelheim Investigational Site | Heraklion | |
| Greece | 205.235.1211 Boehringer Ingelheim Investigational Site | Kavala | |
| Greece | 205.235.1204 Boehringer Ingelheim Investigational Site | Larissa | |
| Greece | 205.235.1209 Boehringer Ingelheim Investigational Site | Patra | |
| Greece | 205.235.1210 Boehringer Ingelheim Investigational Site | Patra | |
| Greece | 205.235.1205 Boehringer Ingelheim Investigational Site | Thessaloniki | |
| Greece | 205.235.1206 Boehringer Ingelheim Investigational Site | Thessaloniki | |
| Greece | 205.235.1207 Boehringer Ingelheim Investigational Site | Thessaloniki | |
| Hong Kong | 205.235.1401 Boehringer Ingelheim Investigational Site | Hong Kong | |
| Hong Kong | 205.235.1403 Boehringer Ingelheim Investigational Site | Hong Kong | |
| Hong Kong | 205.235.1402 Boehringer Ingelheim Investigational Site | Kowloon | |
| Hong Kong | 205.235.1404 Boehringer Ingelheim Investigational Site | Kowloon | |
| Hungary | 205.235.1303 Boehringer Ingelheim Investigational Site | Budapest | |
| Hungary | 205.235.1308 Boehringer Ingelheim Investigational Site | Budapest | |
| Hungary | 205.235.1309 Boehringer Ingelheim Investigational Site | Budapest | |
| Hungary | 205.235.1310 Boehringer Ingelheim Investigational Site | Budapest | |
| Hungary | 205.235.1311 Boehringer Ingelheim Investigational Site | Budapest | |
| Hungary | 205.235.1318 Boehringer Ingelheim Investigational Site | Debrecen | |
| Hungary | 205.235.1314 Boehringer Ingelheim Investigational Site | Deszk | |
| Hungary | 205.235.1306 Boehringer Ingelheim Investigational Site | Erd | |
| Hungary | 205.235.1315 Boehringer Ingelheim Investigational Site | Farkasgyepü | |
| Hungary | 205.235.1320 Boehringer Ingelheim Investigational Site | Gyula | |
| Hungary | 205.235.1307 Boehringer Ingelheim Investigational Site | Kiskunhalas | |
| Hungary | 205.235.1304 Boehringer Ingelheim Investigational Site | Miskolc | |
| Hungary | 205.235.1317 Boehringer Ingelheim Investigational Site | Mosonmagyarovar | |
| Hungary | 205.235.1301 Boehringer Ingelheim Investigational Site | Pecs | |
| Hungary | 205.235.1313 Boehringer Ingelheim Investigational Site | Solymar | |
| Hungary | 205.235.1305 Boehringer Ingelheim Investigational Site | Sopron | |
| Hungary | 205.235.1319 Boehringer Ingelheim Investigational Site | Szombathely | |
| Hungary | 205.235.1302 Boehringer Ingelheim Investigational Site | Tatabanya | |
| Hungary | 205.235.1316 Boehringer Ingelheim Investigational Site | Törökbalint | |
| Hungary | 205.235.1312 Boehringer Ingelheim Investigational Site | Veszprem | |
| Ireland | 205.235.1505 Boehringer Ingelheim Investigational Site | Dublin 15 | |
| Ireland | 205.235.1503 Boehringer Ingelheim Investigational Site | Dublin 4 | |
| Ireland | 205.235.1501 Boehringer Ingelheim Investigational Site | Dublin 9 | |
| Italy | 205.235.1631 A. O. SS. Antonio e Biagio e Arrigo | Alessandria | |
| Italy | 205.235.1613 A. O. S. Giuseppe Moscati | Avellino | |
| Italy | 205.235.1618 Ospedale Bellaria | Bologna | |
| Italy | 205.235.1649 Ospedale di Circolo di Busto Arsizio | Busto Arsizio (VA) | |
| Italy | 205.235.1635 P. O. Roberto Binaghi | Cagliari | |
| Italy | 205.235.1623 A. O. di Carrara | Carrara (Massa) | |
| Italy | 205.235.1645 Ospedale Civile "Zappatoni" | CASSANO D'ADDA (Milano) | |
| Italy | 205.235.1617 Ospedale S. Camillo De Lellis | Chieti | |
| Italy | 205.235.1612 A. O. S. Antonio Abate | Erice (Trapani) | |
| Italy | 205.235.1622 A. O. S. Anna | Ferrara | |
| Italy | 205.235.1646 A. O. di Careggi | Firenze | |
| Italy | 205.235.1647 A. O. Careggi | Firenze | |
| Italy | 205.235.1615 Ospedale S. Martino | Genova | |
| Italy | 205.235.1603 P. O. di Gubbio | Gubbio (Perugia) | |
| Italy | 205.235.1619 A. O. Fratelli Crobu | Iglesias (Cagliari) | |
| Italy | 205.235.1648 Ospedale "S. Maria di Collemaggio" | L'Aquila | |
| Italy | 205.235.1624 Ospedale di Macerata | Macerata | |
| Italy | 205.235.1634 P. O. Luigi Sacco | Milano | |
| Italy | 205.235.1639 Ospedale Maggiore | Modica (Ragusa) | |
| Italy | 205.235.1629 A. O. S. Luigi Gonzaga | Orbassano (Torino) | |
| Italy | 205.235.1604 P. O. R. Silvestrini | Perugia | |
| Italy | 205.235.1601 Presidio Ospedaliero di Cisanello | Pisa | |
| Italy | 205.235.1643 A. O. Santa Maria degli Angeli | Pordenone | |
| Italy | 205.235.1614 Ospedale Misericordia e Dolce | Prato | |
| Italy | 205.235.1607 Università degli Studi di Sassari | Sassari | |
| Italy | 205.235.1608 ASL 1 di Sassari | Sassari | |
| Italy | 205.235.1606 ASL 4 di Terni | Terni | |
| Italy | 205.235.1632 ASL 4 - Distretto 2 | Torino | |
| Italy | 205.235.1633 A. O. Umberto I | Torrette di Ancona (Ancona) | |
| Italy | 205.235.1640 P. O. Cà Foncello | Treviso | |
| Italy | 205.235.1602 Ospedale di Voghera | Voghera (Pavia) | |
| Japan | 205.235.1706 Juntendo University Hospital | Bunkyo-ku, Tokyo | |
| Japan | 205.235.1705 Kameda Medical Center | Kamogawa, Chiba | |
| Japan | 205.235.1713 Komaki City Hospital | Komaki, Aichi | |
| Japan | 205.235.1712 Kurume University Hospital | Kurume, Fukuoka | |
| Japan | 205.235.1708 Shinshu University | Matsumoto, Nagano | |
| Japan | 205.235.1702 Iwate Medical University Hospital | Morioka, Iwate | |
| Japan | 205.235.1710 Osaka City University Hospital | Osaka, Osaka | |
| Japan | 205.235.1711 Kinki University Hospital | Osakasayama, Osaka | |
| Japan | 205.235.1701 Hokkaido University | Sapporo, Hokkaido | |
| Japan | 205.235.1703 Tohoku University Hospital | Sendai, Miyagi | |
| Japan | 205.235.1709 Tosei General Hospital | Seto, Aichi | |
| Japan | 205.235.1704 Hiraka General Hospital | Yokote, Akita | |
| Lithuania | 205.235.1801 Boehringer Ingelheim Investigational Site | Kaunas | |
| Lithuania | 205.235.1802 Boehringer Ingelheim Investigational Site | Kaunas | |
| Lithuania | 205.235.1803 Boehringer Ingelheim Investigational Site | Vilnius | |
| Malaysia | 205.235.1901 Boehringer Ingelheim Investigational Site | Kuala Lumpur | |
| Malaysia | 205.235.1902 Boehringer Ingelheim Investigational Site | Kuala Lumpur | |
| Malaysia | 205.235.1903 Boehringer Ingelheim Investigational Site | Kuala Lumpur | |
| Mexico | 205.235.2005 | Ciudad de Mexico | |
| Mexico | 205.235.2006 Tlalpan 4000, Pabellón 5, EPOC | Ciudad de Mexico | |
| Mexico | 205.235.2004 Edif. Dr. Rodrigo F. Barragan, P.B. | Col. Mitras Centro, Monterrey, N.L. | |
| Mexico | 205.235.2002 | Guadalajara, Jal. | |
| Mexico | 205.235.2009 | Puebla | |
| Mexico | 205.235.2010 Depto. De Ivestigación | Toluca | |
| Mexico | 205.235.2003 | Zapopan, jalisco | |
| Netherlands | 205.235.2110 Poli Longziekten | Almelo | |
| Netherlands | 205.235.2105 Lokatie De Lichtenberg | Amersfoort | |
| Netherlands | 205.235.2107 Poli Longziekten | Delft | |
| Netherlands | 205.235.2106 Lokatie Dordwijk | Dordrecht | |
| Netherlands | 205.235.2104 Poli longziekten | Eindhoven | |
| Netherlands | 205.235.2102 Martini Ziekenhuis Groningen | Groningen | |
| Netherlands | 205.235.2112 Poli Longziekten | Harderwijk | |
| Netherlands | 205.235.2115 Poli Longziekten | Heerenveen | |
| Netherlands | 205.235.2101 Atrium medisch centrum | Heerlen | |
| Netherlands | 205.235.2114 Poli Longziekten | Hengelo | |
| Netherlands | 205.235.2108 Poli Longziekten | Leeuwarden | |
| Netherlands | 205.235.2109 Poli Longziekten | Rotterdam | |
| Netherlands | 205.235.2111 Antonius Ziekenhuis | Sneek | |
| New Zealand | 205.235.0211 Boehringer Ingelheim Investigational Site | Auckland | |
| New Zealand | 205.235.0212 Boehringer Ingelheim Investigational Site | Christchurch, New Zealand | |
| Norway | 205.235.2202 Boehringer Ingelheim Investigational Site | Arendal | |
| Norway | 205.235.2201 Boehringer Ingelheim Investigational Site | Fredrikstad | |
| Norway | 205.235.2205 Boehringer Ingelheim Investigational Site | Sandvika | |
| Norway | 205.235.2204 Boehringer Ingelheim Investigational Site | Straume | |
| Philippines | 205.235.2301 Philippine General Hospital | Manila | |
| Philippines | 205.235.2305 University of Santo Tomas Hospital | Manila | |
| Philippines | 205.235.2302 Philippine Heart Center | Quezon City | |
| Philippines | 205.235.2303 Veterans Memorial Medical Center | Quezon City | |
| Philippines | 205.235.2304 Lung Center of the Philippines | Quezon City | |
| Poland | 205.235.2410 Boehringer Ingelheim Investigational Site | Gdansk | |
| Poland | 205.235.2407 Boehringer Ingelheim Investigational Site | Katowice | |
| Poland | 205.235.2408 Boehringer Ingelheim Investigational Site | Krakow | |
| Poland | 205.235.2405 Boehringer Ingelheim Investigational Site | Lodz | |
| Poland | 205.235.2409 Boehringer Ingelheim Investigational Site | Lodz | |
| Poland | 205.235.2401 Boehringer Ingelheim Investigational Site | Warsaw | |
| Poland | 205.235.2402 Boehringer Ingelheim Investigational Site | Warsaw | |
| Poland | 205.235.2403 Boehringer Ingelheim Investigational Site | Warsaw | |
| Poland | 205.235.2404 Boehringer Ingelheim Investigational Site | Wroclaw | |
| Poland | 205.235.2406 Boehringer Ingelheim Investigational Site | Zabrze | |
| Portugal | 205.235.2504 Centro Hospitalar de Coimbra | Coimbra | |
| Portugal | 205.235.2503 Hospital Pulido Valente | Lisboa | |
| Portugal | 205.235.2505 Hospital de Santa Marta | Lisboa | |
| Portugal | 205.235.2501 Hospital de São João | Porto | |
| Portugal | 205.235.2502 Centro Hospitalar de Vila Nova de Gaia | Vila Nova de Gaia | |
| Russian Federation | 205.235.2601 Boehringer Ingelheim Investigational Site | Moscow | |
| Russian Federation | 205.235.2602 Boehringer Ingelheim Investigational Site | Moscow | |
| Russian Federation | 205.235.2603 Boehringer Ingelheim Investigational Site | Moscow | |
| Russian Federation | 205.235.2605 Boehringer Ingelheim Investigational Site | Moscow | |
| Russian Federation | 205.235.2604 Boehringer Ingelheim Investigational Site | St. Petersburg | |
| Singapore | 205.235.1904 Boehringer Ingelheim Investigational Site | Singapore | |
| Singapore | 205.235.1905 Boehringer Ingelheim Investigational Site | Singapore | |
| Singapore | 205.235.1906 Boehringer Ingelheim Investigational Site | Singapore | |
| Slovakia | 205.235.2701 Boehringer Ingelheim Investigational Site | Bratislava | |
| Slovakia | 205.235.2702 Boehringer Ingelheim Investigational Site | Bratislava | |
| Slovakia | 205.235.2703 Boehringer Ingelheim Investigational Site | Martin | |
| Slovakia | 205.235.2704 Boehringer Ingelheim Investigational Site | Poprad | |
| Slovakia | 205.235.2705 Boehringer Ingelheim Investigational Site | Topolcany | |
| Slovenia | 205.235.2801 Boehringer Ingelheim Investigational Site | Golnik | |
| Slovenia | 205.235.2802 Boehringer Ingelheim Investigational Site | Golnik | |
| Slovenia | 205.235.2805 Boehringer Ingelheim Investigational Site | Kamnik | |
| Slovenia | 205.235.2803 Boehringer Ingelheim Investigational Site | Ljubljana | |
| Slovenia | 205.235.2804 Boehringer Ingelheim Investigational Site | Topolsica | |
| South Africa | 205.235.2908 | Bloemfontein | |
| South Africa | 205.235.2910 | Cape Town | |
| South Africa | 205.235.2912 | Cape Town | |
| South Africa | 205.235.2904 | Durban | |
| South Africa | 205.235.2911 | Durban | |
| South Africa | 205.235.2902 | George | |
| South Africa | 205.235.2905 | Paarl | |
| South Africa | 205.235.2901 Boehringer Ingelheim Investigational Site | Pretoria | |
| South Africa | 205.235.2906 | Somerset West | |
| South Africa | 205.235.2903 | Vanderbijlpark | |
| South Africa | 205.235.2909 | Welkom | |
| Spain | 205.235.3014 Complejo Hospitalario Juan Canalejo | A Coruña | |
| Spain | 205.235.3026 Hospital General Universitario de Alicante | Alicante | |
| Spain | 205.235.3011 Complejo Hospitalario Infanta Cristina | Badajoz | |
| Spain | 205.235.3006 Hospital Germans Trias i Pujol | Badalona (Barcelona) | |
| Spain | 205.235.3022 Hospital de Cruces | Barakaldo (Bilbao) | |
| Spain | 205.235.3003 Hospital Clínic i Provincial de Barcelona | Barcelona | |
| Spain | 205.235.3008 Hospital Vall d'Hebrón | Barcelona | |
| Spain | 205.235.3023 Hospital Dr. Josep Trueta | Girona | |
| Spain | 205.235.3004 Hospital General Universitario de Guadalajara | Guadalajara | |
| Spain | 205.235.3005 Hospital General San Jorge de Huesca | Huesca | |
| Spain | 205.235.3021 Hospital de Jerez de la Frontera | Jerez de la Frontera | |
| Spain | 205.235.3010 Hospital Severo Ochoa | Leganés, Madrid | |
| Spain | 205.235.3009 Hospital Clínico San Carlos | Madrid | |
| Spain | 205.235.3013 Clínica Puerta de Hierro | Madrid | |
| Spain | 205.235.3017 Hospital Ramón y Cajal | Madrid | |
| Spain | 205.235.3020 Hospital Universitario La Paz | Madrid | |
| Spain | 205.235.3028 Hospital Universitario de la Princesa | Madrid | |
| Spain | 205.235.3031 Hospital Gregorio Marañón | Madrid | |
| Spain | 205.235.3036 Hospital 12 de Octubre | Madrid | |
| Spain | 205.235.3033 Hospital General Carlos Haya | Málaga | |
| Spain | 205.235.3027 Complejo Asistencial Son Dureta | Palma de Mallorca | |
| Spain | 205.235.3024 Hospital de Montecelo | Pontevedra | |
| Spain | 205.235.3016 Hospital Universitari de Sant Joan | Reus (Tarragona) | |
| Spain | 205.235.3015 Corporació Sanitaria Parc Taulí de Sabadell | Sabadell (Barcelona) | |
| Spain | 205.235.3037 Hsopital Universitario Ntra. Sra. de la Candelaria | Santa Cruz de Tenerife | |
| Spain | 205.235.3039 Hospital Universitario Marqués de Valdecilla | Santander | |
| Spain | 205.235.3019 Hospital Vírgen de la Macarena | Sevilla | |
| Spain | 205.235.3035 Hospital Universitario Vírgen del Rocío | Sevilla | |
| Spain | 205.235.3001 Hospital Mutua Terrassa | Terrassa (Barcelona) | |
| Spain | 205.235.3002 Hospital Clínico Universitario de Valencia | Valencia | |
| Spain | 205.235.3025 Hospital Universitario Dr. Peset | Valencia | |
| Spain | 205.235.3032 Hospital Arnau de Vilanova | Valencia | |
| Spain | 205.235.3034 Hospital La Fe | Valencia | |
| Spain | 205.235.3018 Complejo Hospitalario Xeral - Cíes | Vigo | |
| Spain | 205.235.3030 Hospital Miguel Servet | Zaragoza | |
| Spain | 205.235.3038 Hospital Clínico Lozano Blesa | Zaragoza | |
| Switzerland | 205.235.3202 Boehringer Ingelheim Investigational Site | Basel | |
| Switzerland | 205.235.3203 Universitätsspital Basel | Basel | |
| Switzerland | 205.235.3204 Boehringer Ingelheim Investigational Site | Faltigberg | |
| Switzerland | 205.235.3205 Boehringer Ingelheim Investigational Site | Lugano | |
| Switzerland | 205.235.3206 Boehringer Ingelheim Investigational Site | Montana | |
| Switzerland | 205.235.3208 Boehringer Ingelheim Investigational Site | Winterthur | |
| Switzerland | 205.235.3201 Boehringer Ingelheim Investigational Site | Zürich | |
| Taiwan | 205.235.3301 Boehringer Ingelheim Investigational Site | Taipei | |
| Taiwan | 205.235.3302 Boehringer Ingelheim Investigational Site | Taipei | |
| Taiwan | 205.235.3303 Boehringer Ingelheim Investigational Site | Taipei | |
| Thailand | 205.235.3402 Boehringer Ingelheim Investigational Site | Bangkok | |
| Thailand | 205.235.3403 Boehringer Ingelheim Investigational Site | Bangkok | |
| Thailand | 205.235.3404 Boehringer Ingelheim Investigational Site | Bangkok | |
| Thailand | 205.235.3401 Boehringer Ingelheim Investigational Site | Chiang Mai | |
| Thailand | 205.235.3405 Boehringer Ingelheim Investigational Site | Khon Kaen | |
| Turkey | 205.235.3510 Cukurova Tip Fakultesi Balcali Hastanesi | Adana | |
| Turkey | 205.235.3506 Hacettepe Tip Fakultesi | Ankara | |
| Turkey | 205.235.3507 Ankara SSK Diskapi Egitim Hastanesi | Ankara | |
| Turkey | 205.235.3508 Atatürk Gögüs Hastaliklari ve Gögüs Cerrahi | Ankara | |
| Turkey | 205.235.3509 Atatürk Üniversitesi Tip Fakultesi Aziziye | Erzurum | |
| Turkey | 205.235.3511 Osmangazi Universitesi Tip Fakültesi | Eskisehir | |
| Turkey | 205.235.3501 Istanbul Universitesi Cerrahpasa Tip Fakultesi | Istanbul | |
| Turkey | 205.235.3502 Yedikule Gögüs Hastaliklari Hastanesi | Istanbul | |
| Turkey | 205.235.3503 Tophanelioglu Cad. No: 13/15 | Istanbul | |
| Turkey | 205.235.3504 Cevizli E5 Karayolu | Istanbul | |
| Turkey | 205.235.3505 Istanbul Universitesi Tip Fakültesi | Istanbul | |
| Turkey | 205.235.3512 DokuzEylül Universitesi Tip Fakultesi Gögüs Hastaliklari ABD | Izmir | |
| United Kingdom | 205.235.3615 Boehringer Ingelheim Investigational Site | Aberdeen | |
| United Kingdom | 205.235.3611 Boehringer Ingelheim Investigational Site | Chertsey | |
| United Kingdom | 205.235.3613 Boehringer Ingelheim Investigational Site | Chesterfield | |
| United Kingdom | 205.235.3608 Boehringer Ingelheim Investigational Site | Cottingham, Hull | |
| United Kingdom | 205.235.3605 Boehringer Ingelheim Investigational Site | Exeter | |
| United Kingdom | 205.235.3602 Boehringer Ingelheim Investigational Site | Glasgow | |
| United Kingdom | 205.235.3610 Boehringer Ingelheim Investigational Site | Leeds | |
| United Kingdom | 205.235.3607 Boehringer Ingelheim Investigational Site | Leicester | |
| United Kingdom | 205.235.3604 Boehringer Ingelheim Investigational Site | Middleton | |
| United Kingdom | 205.235.3612 Boehringer Ingelheim Investigational Site | Nottingham | |
| United Kingdom | 205.235.3616 Boehringer Ingelheim Investigational Site | Paisley | |
| United Kingdom | 205.235.3614 Boehringer Ingelheim Investigational Site | Penarth | |
| United Kingdom | 205.235.3603 Boehringer Ingelheim Investigational Site | Plymouth | |
| United Kingdom | 205.235.3609 Boehringer Ingelheim Investigational Site | Sheffield | |
| United Kingdom | 205.235.3601 Boehringer Ingelheim Investigational Site | Solihull, Birmingham | |
| United States | 205.235.3796 Boehringer Ingelheim Investigational Site | Albany | New York |
| United States | 205.235.3813 Boehringer Ingelheim Investigational Site | Ann Arbor | Michigan |
| United States | 205.235.3779 Boehringer Ingelheim Investigational Site | Anniston | Alabama |
| United States | 205.235.3719 Boehringer Ingelheim Investigational Site | Atlanta | Georgia |
| United States | 205.235.3790 Boehringer Ingelheim Investigational Site | Atlanta | Georgia |
| United States | 205.235.3716 Boehringer Ingelheim Investigational Site | Augusta | Georgia |
| United States | 205.235.3806 Boehringer Ingelheim Investigational Site | Baltimore | Maryland |
| United States | 205.235.3706 Boehringer Ingelheim Investigational Site | Bay Pines | Florida |
| United States | 205.235.3807 Boehringer Ingelheim Investigational Site | Bayshore | New York |
| United States | 205.235.3750 Boehringer Ingelheim Investigational Site | Bidderford | Maine |
| United States | 205.235.3785 Boehringer Ingelheim Investigational Site | Birmingham | Alabama |
| United States | 205.235.3721 Boehringer Ingelheim Investigational Site | Boston | Massachusetts |
| United States | 205.235.3762 Boehringer Ingelheim Investigational Site | Brandon | Florida |
| United States | 205.235.3816 Boehringer Ingelheim Investigational Site | Bronx | New York |
| United States | 205.235.3730 Boehringer Ingelheim Investigational Site | Burlington | North Carolina |
| United States | 205.235.3770 Boehringer Ingelheim Investigational Site | Carmichael | California |
| United States | 205.235.3731 Boehringer Ingelheim Investigational Site | Chapel Hill | North Carolina |
| United States | 205.235.3797 Boehringer Ingelheim Investigational Site | Cherry Hill | New Jersey |
| United States | 205.235.3734 Boehringer Ingelheim Investigational Site | Chesterfield | Missouri |
| United States | 205.235.3723 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio |
| United States | 205.235.3701 Boehringer Ingelheim Investigational Site | Cleveland | Ohio |
| United States | 205.235.3724 Boehringer Ingelheim Investigational Site | Coeur d'Alene | Idaho |
| United States | 205.235.3744 Boehringer Ingelheim Investigational Site | Danville | Virginia |
| United States | 205.235.3764 Boehringer Ingelheim Investigational Site | Denver | Colorado |
| United States | 205.235.3732 Boehringer Ingelheim Investigational Site | Detroit | Michigan |
| United States | 205.235.3749 Boehringer Ingelheim Investigational Site | Dubuque | Iowa |
| United States | 205.235.3736 Boehringer Ingelheim Investigational Site | Durham | North Carolina |
| United States | 205.235.3803 Boehringer Ingelheim Investigational Site | El Paso | Texas |
| United States | 205.235.3745 Boehringer Ingelheim Investigational Site | Elizabath City | North Carolina |
| United States | 205.235.3778 Boehringer Ingelheim Investigational Site | Escondito | California |
| United States | 205.235.3782 Boehringer Ingelheim Investigational Site | Fredericksburg | Virginia |
| United States | 205.235.3727 Boehringer Ingelheim Investigational Site | Hartford | Connecticut |
| United States | 205.235.3808 Boehringer Ingelheim Investigational Site | Hartford | Connecticut |
| United States | 205.235.3725 Boehringer Ingelheim Investigational Site | Hershey | Pennsylvania |
| United States | 205.235.3742 Boehringer Ingelheim Investigational Site | Houston | Texas |
| United States | 205.235.3787 Boehringer Ingelheim Investigational Site | Houston | Texas |
| United States | 205.235.3768 Boehringer Ingelheim Investigational Site | Indianapolis | Indiana |
| United States | 205.235.3804 Boehringer Ingelheim Investigational Site | Jasper | Alabama |
| United States | 205.235.3814 Boehringer Ingelheim Investigational Site | Kansas City | Missouri |
| United States | 205.235.3780 Boehringer Ingelheim Investigational Site | La Crosse | Wisconsin |
| United States | 205.235.3810 Boehringer Ingelheim Investigational Site | Lakewood | California |
| United States | 205.235.3765 Boehringer Ingelheim Investigational Site | Larchmont | New York |
| United States | 205.235.3707 Boehringer Ingelheim Investigational Site | Largo | Florida |
| United States | 205.235.3763 Boehringer Ingelheim Investigational Site | Lebanon | New Hampshire |
| United States | 205.235.3729 Boehringer Ingelheim Investigational Site | Lexington | Kentucky |
| United States | 205.235.3809 Boehringer Ingelheim Investigational Site | Livonia | Michigan |
| United States | 205.235.3758 Boehringer Ingelheim Investigational Site | Long Beach | California |
| United States | 205.235.3812 Boehringer Ingelheim Investigational Site | Long Beach | California |
| United States | 205.235.3773 Boehringer Ingelheim Investigational Site | Los Angeles | California |
| United States | 205.235.3800 Boehringer Ingelheim Investigational Site | Los Angeles | California |
| United States | 205.235.3802 Boehringer Ingelheim Investigational Site | Los Angeles | California |
| United States | 205.235.3771 Boehringer Ingelheim Investigational Site | Lynchburg | Virginia |
| United States | 205.235.3703 Boehringer Ingelheim Investigational Site | Melbourne | Florida |
| United States | 205.235.3737 Boehringer Ingelheim Investigational Site | Metairie | Louisiana |
| United States | 205.235.3748 Boehringer Ingelheim Investigational Site | Mineola | New York |
| United States | 205.235.3751 Boehringer Ingelheim Investigational Site | Minneapolis | Minnesota |
| United States | 205.235.3754 Boehringer Ingelheim Investigational Site | Minneapolis | Minnesota |
| United States | 205.235.3795 Boehringer Ingelheim Investigational Site | Mobile | Alabama |
| United States | 205.235.3818 Boehringer Ingelheim Investigational Site | New York | New York |
| United States | 205.235.3713 Boehringer Ingelheim Investigational Site | Normal | Illinois |
| United States | 205.235.3793 Boehringer Ingelheim Investigational Site | Norwalk | Connecticut |
| United States | 205.235.3757 Boehringer Ingelheim Investigational Site | Olathe | Kansas |
| United States | 205.235.3786 Pulmonary and Critical Care Medicine | Orange | California |
| United States | 205.235.3811 Boehringer Ingelheim Investigational Site | Palo Alto | California |
| United States | 205.235.3775 Boehringer Ingelheim Investigational Site | Panama City | Florida |
| United States | 205.235.3817 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania |
| United States | 205.235.3759 Boehringer Ingelheim Investigational Site | Phoenix | Arizona |
| United States | 205.235.3820 Boehringer Ingelheim Investigational Site | Portland | Oregon |
| United States | 205.235.3715 Boehringer Ingelheim Investigational Site | Providence | Rhode Island |
| United States | 205.235.3741 Boehringer Ingelheim Investigational Site | Rancho Mirage | California |
| United States | 205.235.3738 Boehringer Ingelheim Investigational Site | Richmond | Virginia |
| United States | 205.235.3792 Boehringer Ingelheim Investigational Site | Richmond | Virginia |
| United States | 205.235.3722 Boehringer Ingelheim Investigational Site | Rochester | New York |
| United States | 205.235.3789 Boehringer Ingelheim Investigational Site | Rochester | Minnesota |
| United States | 205.235.3761 Boehringer Ingelheim Investigational Site | Salem | Virginia |
| United States | 205.235.3752 Boehringer Ingelheim Investigational Site | Salt Lake City | Utah |
| United States | 205.235.3704 Boehringer Ingelheim Investigational Site | San Antonio | Texas |
| United States | 205.235.3717 Boehringer Ingelheim Investigational Site | San Diego | California |
| United States | 205.235.3781 Boehringer Ingelheim Investigational Site | San Diego | California |
| United States | 205.235.3784 Boehringer Ingelheim Investigational Site | San Diego | California |
| United States | 205.235.3743 Boehringer Ingelheim Investigational Site | Sarasota | Florida |
| United States | 205.235.3760 Boehringer Ingelheim Investigational Site | Sepulveda | California |
| United States | 205.235.3788 Boehringer Ingelheim Investigational Site | Shreveport | Louisiana |
| United States | 205.235.3718 Boehringer Ingelheim Investigational Site | Spokane | Washington |
| United States | 205.235.3726 354 Birnie Ave | Springfield | Massachusetts |
| United States | 205.235.3747 Boehringer Ingelheim Investigational Site | St. Louis | Missouri |
| United States | 205.235.3794 Boehringer Ingelheim Investigational Site | Stockbridge | Georgia |
| United States | 205.235.3711 Boehringer Ingelheim Investigational Site | Stockton | California |
| United States | 205.235.3799 Boehringer Ingelheim Investigational Site | Summit | New Jersey |
| United States | 205.235.3756 Boehringer Ingelheim Investigational Site | Tampa | Florida |
| United States | 205.235.3791 Boehringer Ingelheim Investigational Site | Tulsa | Oklahoma |
| United States | 205.235.3815 Boehringer Ingelheim Investigational Site | WEst Haven | Connecticut |
| United States | 205.235.3739 Boehringer Ingelheim Investigational Site | West Palm Beach | Florida |
| United States | 205.235.3783 Boehringer Ingelheim Investigational Site | Wheat Ridge | Colorado |
| United States | 205.235.3712 Boehringer Ingelheim Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
United States, Argentina, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Russian Federation, Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Incidence Rate of Serious Adverse Event (System Organ Class = Cardiac Disorders) | Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100. | Day 1 to completion of double blinded treatment plus 30 days | |
| Other | Incidence Rate of Serious Adverse Event (Preferred Term = Angina) | Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100. | Day 1 to completion of double blinded treatment plus 30 days | |
| Other | Incidence Rate of Serious Adverse Event (Preferred Term = Atrial Fibrillation) | Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100. | Day 1 to completion of double blinded treatment plus 30 days | |
| Other | Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure) | Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100. | Day 1 to completion of double blinded treatment plus 30 days | |
| Other | Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure Congestive) | Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100. | Day 1 to completion of double blinded treatment plus 30 days | |
| Other | Incidence Rate of Serious Adverse Event (Preferred Term = Coronary Artery Disease) | Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100. | Day 1 to completion of double blinded treatment plus 30 days | |
| Other | Incidence Rate of Serious Adverse Event (Preferred Term = Myocardial Infarction) | Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100. | Day 1 to completion of double blinded treatment plus 30 days | |
| Other | Incidence Rate of Serious Adverse Event (System Organ Class = Lower Respiratory System Disorders) | Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100. | Day 1 to completion of double blinded treatment plus 30 days | |
| Other | Incidence Rate of Serious Adverse Event (Preferred Term = Bronchitis) | Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100. | Day 1 to completion of double blinded treatment plus 30 days | |
| Other | Incidence Rate of Serious Adverse Event (Preferred Term = Chronic Obstructive Pulmonary Disease (COPD) Exacerbation) | Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100. | Day 1 to completion of double blinded treatment plus 30 days | |
| Other | Incidence Rate of Serious Adverse Event (Preferred Term = Dyspnoea) | Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100. | Day 1 to completion of double blinded treatment plus 30 days | |
| Other | Incidence Rate of Serious Adverse Event (Preferred Term = Pneumonia) | Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100. | Day 1 to completion of double blinded treatment plus 30 days | |
| Other | Incidence Rate of Serious Adverse Event (Preferred Term = Respiratory Failure) | Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100. | Day 1 to completion of double blinded treatment plus 30 days | |
| Primary | Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years | Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1. | From day 30 to 4 years | |
| Primary | Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years | Rate of decline of forced expiratory volume in one second (FEV1) measured after bronchodilation. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1. | From day 30 to 4 years | |
| Secondary | Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment | Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1 | Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days. | |
| Secondary | Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment | Rate of decline of forced expiratory volume in one second (FEV1) measured after the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1 | Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days | |
| Secondary | Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years | Rate of decline of forced vital capacity (FVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC | From day 30 to 4 years | |
| Secondary | Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years | Rate of decline of forced vital capacity (FVC) measured after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC | From day 30 to 4 years | |
| Secondary | Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years | Rate of decline of slow vital capacity (SVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC | From day 30 to 4 years | |
| Secondary | Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years | Rate of decline of slow vital capacity (SVC) measured after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC | From day 30 to 4 years | |
| Secondary | Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score | SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health). | From month 6 to 4 years | |
| Secondary | Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment | Rate of decline of forced vital capacity (FVC) before bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC | Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days. | |
| Secondary | Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment | Rate of decline of forced vital capacity (FVC) after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC | Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days | |
| Secondary | Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment | Rate of decline slow vital capacity (SVC) before bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC | Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days | |
| Secondary | Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment | Rate of decline of slow vital capacity (SVC) after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC | Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days | |
| Secondary | Time to First Exacerbation | Chronic obstructive pulmonary disease (COPD) exacerbation | From Day 1 to 4 years | |
| Secondary | Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year | Day 1 to 4 years | ||
| Secondary | Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | Day 1 to 4 years | ||
| Secondary | Number of Exacerbation Days Per Patient Year | Number of exacerbation days normalized by treatment exposure | Day 1 to 4 years | |
| Secondary | Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients) | Day 1 to 4 years | ||
| Secondary | Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization | From Day 1 to 4 years | ||
| Secondary | Number of Exacerbation Leading to Hospitalization | Estimated number of exacerbations leading to hospitalizations per patient year | From Day 1 to 4 years | |
| Secondary | Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization | Number of days with chronic obstructive pulmonary disease (COPD) exacerbation leading to hospitalization (normalized by treatment exposure) | From Day 1 to 4 years | |
| Secondary | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1 | Estimated FEV1 before bronchodilator at Month 1 | Month 1 | |
| Secondary | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1 | Estimated forced expiratory volume in one second (FEV1) after bronchodilator at month 1 | Month 1 | |
| Secondary | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6 | Estimated forced expiratory volume in one second (FEV1) before bronchodilator at month 6 | Month 6 | |
| Secondary | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6 | Month 6 | ||
| Secondary | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12 | Month 12 | ||
| Secondary | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12 | Month 12 | ||
| Secondary | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18 | Month 18 | ||
| Secondary | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18 | Month 18 | ||
| Secondary | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24 | Month 24 | ||
| Secondary | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24 | Month 24 | ||
| Secondary | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30 | Month 30 | ||
| Secondary | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30 | Month 30 | ||
| Secondary | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36 | Month 36 | ||
| Secondary | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36 | Month 36 | ||
| Secondary | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42 | Month 42 | ||
| Secondary | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42 | Estimated FEV1 after bronchodilator at Month 42 | Month 42 | |
| Secondary | Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48 | Month 48 | ||
| Secondary | Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48 | Month 48 | ||
| Secondary | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1 | Month 1 | ||
| Secondary | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1 | Month 1 | ||
| Secondary | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6 | Month 6 | ||
| Secondary | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6 | Month 6 | ||
| Secondary | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12 | Month 12 | ||
| Secondary | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12 | Month 12 | ||
| Secondary | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18 | Month 18 | ||
| Secondary | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18 | Month 18 | ||
| Secondary | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24 | Month 24 | ||
| Secondary | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24 | Month 24 | ||
| Secondary | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30 | Month 30 | ||
| Secondary | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30 | Month 30 | ||
| Secondary | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36 | Month 36 | ||
| Secondary | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36 | Month 36 | ||
| Secondary | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42 | Month 42 | ||
| Secondary | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42 | Month 42 | ||
| Secondary | Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48 | Month 48 | ||
| Secondary | Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48 | Month 48 | ||
| Secondary | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1 | Month 1 | ||
| Secondary | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1 | Month 1 | ||
| Secondary | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6 | Month 6 | ||
| Secondary | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6 | Month 6 | ||
| Secondary | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12 | Month 12 | ||
| Secondary | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12 | Month 12 | ||
| Secondary | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18 | Month 18 | ||
| Secondary | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18 | Month 18 | ||
| Secondary | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24 | Month 24 | ||
| Secondary | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24 | Month 24 | ||
| Secondary | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30 | Month 30 | ||
| Secondary | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30 | Month 30 | ||
| Secondary | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36 | Month 36 | ||
| Secondary | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36 | Month 36 | ||
| Secondary | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42 | Month 42 | ||
| Secondary | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42 | Month 42 | ||
| Secondary | Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48 | Month 48 | ||
| Secondary | Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48 | Month 48 | ||
| Secondary | Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6 | SGRQ total score summarizes the impact of COPD on overall patient's health status. Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. The scale is continuous. Rate of decline shows the yearly change of SGRQ total score. |
Month 6 | |
| Secondary | Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12 | SGRQ total score summarizes the impact of COPD on overall patient's health status. Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. The scale is continuous. Rate of decline shows the yearly change of SGRQ total score. |
Month 12 | |
| Secondary | Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18 | SGRQ total score summarizes the impact of COPD on overall patient's health status. Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. The scale is continuous. Rate of decline shows the yearly change of SGRQ total score. |
Month 18 | |
| Secondary | Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24 | SGRQ total score summarizes the impact of COPD on overall patient's health status. Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. The scale is continuous. Rate of decline shows the yearly change of SGRQ total score. |
Month 24 | |
| Secondary | Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30 | SGRQ total score summarizes the impact of COPD on overall patient's health status. Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. The scale is continuous. Rate of decline shows the yearly change of SGRQ total score. |
Month 30 | |
| Secondary | Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36 | SGRQ total score summarizes the impact of COPD on overall patient's health status. Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. The scale is continuous. Rate of decline shows the yearly change of SGRQ total score. |
Month 36 | |
| Secondary | Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42 | SGRQ total score summarizes the impact of COPD on overall patient's health status. Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. The scale is continuous. Rate of decline shows the yearly change of SGRQ total score. |
Month 42 | |
| Secondary | Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48 | SGRQ total score summarizes the impact of COPD on overall patient's health status. Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. The scale is continuous. Rate of decline shows the yearly change of SGRQ total score. |
Month 48 | |
| Secondary | Number and Percentage of Participants With All Cause Death and Time to Event Analysis (On-treatment) | On-treatment defined as day 1 to completion of double blinded treatment plus 30 days | Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days | |
| Secondary | Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1470 Days) | All cause mortality vital status information was followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used. | Day 1 to day 1470 | |
| Secondary | Number and Percentage of Participants With Lower Respiratory Death (On-treatment; Adjudicated Primary Cause) | The primary cause of death was adjudicated by an external committee prior to unblinding; on-treatment defined as day 1 to completion of double blinded treatment plus 30 days | Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days | |
| Secondary | Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days) | The primary cause of death was adjudicated by an external committee prior to unblinding; vital status was information followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used | Day 1 to day 1470 |
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