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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00808067
Other study ID # 1160.71
Secondary ID 2008-005248-17
Status Completed
Phase Phase 3
First received December 12, 2008
Last updated June 3, 2014
Start date November 2008
Est. completion date December 2012

Study information

Verified date March 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Australia: Dept of Health and Ageing Therapeutic Goods AdminAustria: Medicines and Medical Devices AgencyBelgium: Federal Agency for Medicines and Health Products, FAMHPBrazil: National Health Surveillance AgencyBulgaria: Bulgarian Drug Agency, BG-1504 SofiaCanada: Health Canada, Therapeutic Products DirectorateChina: Food and Drug AdministrationCzech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10Denmark: The Danish Medicines AgencyFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, D-53175 BonnGreat Britain: MHRAGreece: National Organization fo Medicines (EOF) National Ethics CommitteHong Kong: Department of HealthHungary: National Institute of Pharmacy (OGYI), H-1051 BudapestIndia: Drug Control General of IndiaIsrael: Israeli Health Ministry Pharmaceutical AdministrationItaly: Ethics CommitteeKorea, Republic of: Korea Food and Drug Administration (KFDA)Malaysia: Drug Control AuthorityNetherlands: Central Committee on Research Involving Human Subjects (CCMO)Norway: Norwegian Medicines Agency (Statens Legemiddelverk)Philippines: Bureau of Food and DrugPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPortugal: INFARMED I.P.Romania: National Medicines Agency, BucharestRussia: Ministry of Health of the Russian FederationSingapore: Health Sciences AuthoritySlovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26Sweden: Medical Products Agency Regional Ethics Committee of UppsalaSwitzerland: SwissmedicTaiwan: Department of Health, Executive Yuan, TaiwanThailand: Thai Food & Drug AdministrationUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purposes of this study are:

1. To evaluate the long-term safety of dabigatran etexilate

2. To assess the effect of a knowledge translation intervention on patient outcomes


Recruitment information / eligibility

Status Completed
Enrollment 5897
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

Participation in RE-LY, requires long term anticoagulation, provides written informed consent

Exclusion criteria:

Permanent discontinuation of dabigatran during RE-LY

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
dabigatran dose 1
dabigatran high dose twice daily
dabigatran dose 2
dabigatran low dose twice daily

Locations

Country Name City State
Australia 1160.71.0509 Boehringer Ingelheim Investigational Site Ashford South Australia
Australia 1160.71.0504 Boehringer Ingelheim Investigational Site Box Hill Victoria
Australia 1160.71.0508 Boehringer Ingelheim Investigational Site Coffs Harbour New South Wales
Australia 1160.71.0501 Boehringer Ingelheim Investigational Site Geelong Victoria
Australia 1160.71.0510 Boehringer Ingelheim Investigational Site Gosford New South Wales
Australia 1160.71.0507 Boehringer Ingelheim Investigational Site Launceston Tasmania
Australia 1160.71.0506 Boehringer Ingelheim Investigational Site Milton Queensland
Austria 1160.71.0543 Boehringer Ingelheim Investigational Site Graz
Austria 1160.71.0549 Boehringer Ingelheim Investigational Site Linz
Austria 1160.71.0541 Boehringer Ingelheim Investigational Site Wien
Austria 1160.71.0542 Boehringer Ingelheim Investigational Site Wien
Austria 1160.71.0545 Boehringer Ingelheim Investigational Site Wien
Austria 1160.71.0547 Boehringer Ingelheim Investigational Site Wien
Austria 1160.71.0548 Boehringer Ingelheim Investigational Site Wien
Austria 1160.71.0550 Boehringer Ingelheim Investigational Site Wr. Neustadt
Belgium 1160.71.0564 Boehringer Ingelheim Investigational Site Aalst
Belgium 1160.71.0572 Boehringer Ingelheim Investigational Site Brasschaat
Belgium 1160.71.0571 Boehringer Ingelheim Investigational Site Brussel
Belgium 1160.71.0581 Boehringer Ingelheim Investigational Site Bruxelles
Belgium 1160.71.0585 Boehringer Ingelheim Investigational Site Bruxelles
Belgium 1160.71.0563 Boehringer Ingelheim Investigational Site Edegem
Belgium 1160.71.0578 Boehringer Ingelheim Investigational Site Genk
Belgium 1160.71.0587 Boehringer Ingelheim Investigational Site Genk
Belgium 1160.71.0574 Boehringer Ingelheim Investigational Site Gent
Belgium 1160.71.0588 Boehringer Ingelheim Investigational Site Gilly
Belgium 1160.71.0568 Boehringer Ingelheim Investigational Site Hasselt
Belgium 1160.71.0561 Boehringer Ingelheim Investigational Site Leuven
Belgium 1160.71.0579 Boehringer Ingelheim Investigational Site Liège
Belgium 1160.71.0567 Boehringer Ingelheim Investigational Site Oostende
Belgium 1160.71.0570 Boehringer Ingelheim Investigational Site Roeselare
Belgium 1160.71.0566 Boehringer Ingelheim Investigational Site Tienen
Belgium 1160.71.0562 Boehringer Ingelheim Investigational Site Turnhout
Brazil 1160.71.0644 Boehringer Ingelheim Investigational Site Campinas
Brazil 1160.71.0650 Boehringer Ingelheim Investigational Site Curitiba
Brazil 1160.71.0651 Boehringer Ingelheim Investigational Site Curitiba
Brazil 1160.71.0652 Boehringer Ingelheim Investigational Site Goiania
Brazil 1160.71.0646 Boehringer Ingelheim Investigational Site Sao Jose do Riio Preto
Brazil 1160.71.0647 Boehringer Ingelheim Investigational Site São José do Rio Preto
Brazil 1160.71.0643 Boehringer Ingelheim Investigational Site São Paulo
Bulgaria 1160.71.0620 Boehringer Ingelheim Investigational Site Pleven
Bulgaria 1160.71.0611 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1160.71.0612 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1160.71.0615 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1160.71.0617 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1160.71.0618 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1160.71.0625 Boehringer Ingelheim Investigational Site Sofia
Canada 1160.71.0674 Boehringer Ingelheim Investigational Site Burlington Ontario
Canada 1160.71.0694 Boehringer Ingelheim Investigational Site Calgary Alberta
Canada 1160.71.0696 Boehringer Ingelheim Investigational Site Calgary Alberta
Canada 1160.71.0702 Boehringer Ingelheim Investigational Site Cambridge Ontario
Canada 1160.71.0720 Boehringer Ingelheim Investigational Site Cambridge Ontario
Canada 1160.71.0680 Boehringer Ingelheim Investigational Site Coquitlam British Columbia
Canada 1160.71.0712 Boehringer Ingelheim Investigational Site Coquitlam British Columbia
Canada 1160.71.0692 Boehringer Ingelheim Investigational Site Grimsby Ontario
Canada 1160.71.0703 Boehringer Ingelheim Investigational Site Halifax Nova Scotia
Canada 1160.71.0697 Boehringer Ingelheim Investigational Site Hamilton Ontario
Canada 1160.71.0710 Boehringer Ingelheim Investigational Site Hamilton Ontario
Canada 1160.71.0719 Boehringer Ingelheim Investigational Site Hamilton Ontario
Canada 1160.71.0721 Boehringer Ingelheim Investigational Site Hamilton Ontario
Canada 1160.71.0706 Boehringer Ingelheim Investigational Site Kelowna British Columbia
Canada 1160.71.0708 Boehringer Ingelheim Investigational Site Mississauga Ontario
Canada 1160.71.0683 Boehringer Ingelheim Investigational Site Montreal Quebec
Canada 1160.71.0705 Boehringer Ingelheim Investigational Site Montreal Quebec
Canada 1160.71.0709 Boehringer Ingelheim Investigational Site Montreal Quebec
Canada 1160.71.0716 Boehringer Ingelheim Investigational Site Montreal Quebec
Canada 1160.71.0725 Boehringer Ingelheim Investigational Site Nanaimo British Columbia
Canada 1160.71.0691 Boehringer Ingelheim Investigational Site New Westminster British Columbia
Canada 1160.71.0688 Boehringer Ingelheim Investigational Site Newmarket Ontario
Canada 1160.71.0672 Boehringer Ingelheim Investigational Site Oshawa Ontario
Canada 1160.71.0687 Boehringer Ingelheim Investigational Site Ottawa Ontario
Canada 1160.71.0701 Boehringer Ingelheim Investigational Site Portage la Prairie Manitoba
Canada 1160.71.0700 Boehringer Ingelheim Investigational Site Quebec
Canada 1160.71.0717 Boehringer Ingelheim Investigational Site Quebec City Quebec
Canada 1160.71.0673 Boehringer Ingelheim Investigational Site Saskatoon Saskatchewan
Canada 1160.71.0678 Boehringer Ingelheim Investigational Site Saskatoon Saskatchewan
Canada 1160.71.0679 Boehringer Ingelheim Investigational Site Scarborough Ontario
Canada 1160.71.0723 Boehringer Ingelheim Investigational Site Scarborough Ontario
Canada 1160.71.0699 Boehringer Ingelheim Investigational Site St. Charles-Borromee Quebec
Canada 1160.71.0713 Boehringer Ingelheim Investigational Site St. George-de-Beauce Quebec
Canada 1160.71.0675 Boehringer Ingelheim Investigational Site St. Hyacinthe Quebec
Canada 1160.71.0715 Boehringer Ingelheim Investigational Site Sudbury Ontario
Canada 1160.71.0690 Boehringer Ingelheim Investigational Site Thunder Bay Ontario
Canada 1160.71.0684 Boehringer Ingelheim Investigational Site Toronto Ontario
Canada 1160.71.0718 Boehringer Ingelheim Investigational Site Toronto Ontario
Canada 1160.71.0714 Boehringer Ingelheim Investigational Site Victoria British Columbia
Canada 1160.71.0686 Boehringer Ingelheim Investigational Site Windsor Ontario
China 1160.71.0771 Boehringer Ingelheim Investigational Site Beijing
China 1160.71.0772 Boehringer Ingelheim Investigational Site Beijing
China 1160.71.0773 Boehringer Ingelheim Investigational Site Beijing
China 1160.71.0774 Boehringer Ingelheim Investigational Site Beijing
China 1160.71.0776 Boehringer Ingelheim Investigational Site Haerbin
China 1160.71.0784 Boehringer Ingelheim Investigational Site Hangzhou
China 1160.71.0778 Boehringer Ingelheim Investigational Site QingDao
China 1160.71.0781 Boehringer Ingelheim Investigational Site Shanghai
China 1160.71.0782 Boehringer Ingelheim Investigational Site Shanghai
China 1160.71.0777 Boehringer Ingelheim Investigational Site Shenyang
China 1160.71.0780 Boehringer Ingelheim Investigational Site Shijiazhuang
Czech Republic 1160.71.0816 Boehringer Ingelheim Investigational Site Modrice
Czech Republic 1160.71.0820 Boehringer Ingelheim Investigational Site Ostrava 1
Czech Republic 1160.71.0818 Boehringer Ingelheim Investigational Site Pardubice
Czech Republic 1160.71.0814 Boehringer Ingelheim Investigational Site Plzen-Bory
Czech Republic 1160.71.0811 Boehringer Ingelheim Investigational Site Praha 5
Czech Republic 1160.71.0812 Boehringer Ingelheim Investigational Site Praha 6
Czech Republic 1160.71.0813 Boehringer Ingelheim Investigational Site Praha 9
Czech Republic 1160.71.0817 Boehringer Ingelheim Investigational Site Pribram
Czech Republic 1160.71.0819 Boehringer Ingelheim Investigational Site Usti nad Orlici
Denmark 1160.71.0837 Boehringer Ingelheim Investigational Site Aalborg
Denmark 1160.71.0835 Boehringer Ingelheim Investigational Site Aarhus C
Denmark 1160.71.0838 Boehringer Ingelheim Investigational Site Frederikssund
Denmark 1160.71.0833 Boehringer Ingelheim Investigational Site Helsingør
Denmark 1160.71.0834 Boehringer Ingelheim Investigational Site Herlev
Denmark 1160.71.0841 Boehringer Ingelheim Investigational Site Horsens
Denmark 1160.71.0832 Boehringer Ingelheim Investigational Site Hvidovre
Denmark 1160.71.0840 Boehringer Ingelheim Investigational Site Køge
Denmark 1160.71.0831 Boehringer Ingelheim Investigational Site Odense
Denmark 1160.71.0839 Boehringer Ingelheim Investigational Site Roskilde
Denmark 1160.71.0836 Boehringer Ingelheim Investigational Site Svendborg
Finland 1160.71.0851 Boehringer Ingelheim Investigational Site Helsinki
Finland 1160.71.0859 Boehringer Ingelheim Investigational Site Jyväskylä
Finland 1160.71.0854 Boehringer Ingelheim Investigational Site Oulu
Finland 1160.71.0858 Boehringer Ingelheim Investigational Site Pori
Finland 1160.71.0852 Boehringer Ingelheim Investigational Site Tampere
Finland 1160.71.0853 Boehringer Ingelheim Investigational Site Turku
France 1160.71.875A Boehringer Ingelheim Investigational Site ABBEVILLE cedex
France 1160.71.882D Boehringer Ingelheim Investigational Site Angers
France 1160.71.882G Boehringer Ingelheim Investigational Site Angers
France 1160.71.879F Boehringer Ingelheim Investigational Site Besle Sur Vilaine
France 1160.71.882K Boehringer Ingelheim Investigational Site Château Gontier
France 1160.71.887A Boehringer Ingelheim Investigational Site Cholet
France 1160.71.879C Boehringer Ingelheim Investigational Site Derval
France 1160.71.882H Boehringer Ingelheim Investigational Site Feneu
France 1160.71.888A Boehringer Ingelheim Investigational Site GRENOBLE Cédex 9
France 1160.71.879B Boehringer Ingelheim Investigational Site La Chapelle sur Erdre
France 1160.71.874A Boehringer Ingelheim Investigational Site Langres
France 1160.71.884A Boehringer Ingelheim Investigational Site Laval
France 1160.71.880B Boehringer Ingelheim Investigational Site Le Mesnil en Valée
France 1160.71.880A Boehringer Ingelheim Investigational Site Murs Erigne
France 1160.71.879A Boehringer Ingelheim Investigational Site Nantes
France 1160.71.879H Boehringer Ingelheim Investigational Site Nantes
France 1160.71.879S Boehringer Ingelheim Investigational Site Nantes
France 1160.71.880J Boehringer Ingelheim Investigational Site Parcay les Pins
France 1160.71.871A Boehringer Ingelheim Investigational Site Paris
France 1160.71.879E Boehringer Ingelheim Investigational Site Saint Aubin Des Chateaux
France 1160.71.880D Boehringer Ingelheim Investigational Site Segre
France 1160.71.882A Boehringer Ingelheim Investigational Site Tierce
France 1160.71.882B Boehringer Ingelheim Investigational Site Tierce
France 1160.71.882C Boehringer Ingelheim Investigational Site Tierce
France 1160.71.879G Boehringer Ingelheim Investigational Site Vieillevigne
France 1160.71.880E Boehringer Ingelheim Investigational Site Vihiers
Germany 1160.71.0932 Boehringer Ingelheim Investigational Site Berlin
Germany 1160.71.0948 Boehringer Ingelheim Investigational Site Berlin
Germany 1160.71.0962 Boehringer Ingelheim Investigational Site Berlin
Germany 1160.71.0940 Boehringer Ingelheim Investigational Site Bochum
Germany 1160.71.0972 Boehringer Ingelheim Investigational Site Dortmund
Germany 1160.71.0934 Boehringer Ingelheim Investigational Site Essen
Germany 1160.71.0931 Boehringer Ingelheim Investigational Site Frankfurt am Main
Germany 1160.71.0943 Boehringer Ingelheim Investigational Site Heidelberg
Germany 1160.71.0963 Boehringer Ingelheim Investigational Site Köln
Germany 1160.71.0946 Boehringer Ingelheim Investigational Site Lahr
Germany 1160.71.0944 Boehringer Ingelheim Investigational Site Limburg
Germany 1160.71.0951 Boehringer Ingelheim Investigational Site Mainz
Germany 1160.71.0933 Boehringer Ingelheim Investigational Site Mannheim
Germany 1160.71.0945 Boehringer Ingelheim Investigational Site Mannheim
Germany 1160.71.0970 Boehringer Ingelheim Investigational Site Mannheim
Germany 1160.71.0937 Boehringer Ingelheim Investigational Site Witten
Germany 1160.71.0966 Boehringer Ingelheim Investigational Site Wuppertal
Greece 1160.71.0901 Boehringer Ingelheim Investigational Site Athens
Greece 1160.71.0914 Boehringer Ingelheim Investigational Site Kalamaria-Thessaloniki
Greece 1160.71.0904 Boehringer Ingelheim Investigational Site Larissa
Greece 1160.71.0910 Boehringer Ingelheim Investigational Site Thiva
Greece 1160.71.0903 Boehringer Ingelheim Investigational Site Trikala
Greece 1160.71.0905 Boehringer Ingelheim Investigational Site Voula - Athens
Hong Kong 1160.71.1003 Boehringer Ingelheim Investigational Site Kowloon
Hong Kong 1160.71.1004 Boehringer Ingelheim Investigational Site Kowloon
Hungary 1160.71.1011 Boehringer Ingelheim Investigational Site Budapest
Hungary 1160.71.1012 Boehringer Ingelheim Investigational Site Budapest
Hungary 1160.71.1013 Boehringer Ingelheim Investigational Site Budapest
Hungary 1160.71.1014 Boehringer Ingelheim Investigational Site Budapest
Hungary 1160.71.1015 Boehringer Ingelheim Investigational Site Budapest
Hungary 1160.71.1016 Boehringer Ingelheim Investigational Site Budapest
Hungary 1160.71.1020 Boehringer Ingelheim Investigational Site Gyongyos
Hungary 1160.71.1017 Boehringer Ingelheim Investigational Site Komarom
Hungary 1160.71.1018 Boehringer Ingelheim Investigational Site Pecs
India 1160.71.1057 Boehringer Ingelheim Investigational Site Ahmedabad
India 1160.71.1056 Boehringer Ingelheim Investigational Site Ahmedabad-52
India 1160.71.1065 Boehringer Ingelheim Investigational Site Bangalore
India 1160.71.1062 Boehringer Ingelheim Investigational Site Hyderabad
India 1160.71.1073 Boehringer Ingelheim Investigational Site Jaipur, Rajasthan
India 1160.71.1067 Boehringer Ingelheim Investigational Site Kerala
India 1160.71.1068 Boehringer Ingelheim Investigational Site Kottayam
India 1160.71.1055 Boehringer Ingelheim Investigational Site Lucknow, Uttar Pradesh
India 1160.71.1051 Boehringer Ingelheim Investigational Site Ludhiana
India 1160.71.1072 Boehringer Ingelheim Investigational Site Mysore
India 1160.71.1059 Boehringer Ingelheim Investigational Site Nagpur-12
India 1160.71.1052 Boehringer Ingelheim Investigational Site New Delhi
India 1160.71.1070 Boehringer Ingelheim Investigational Site Pune, Maharashtra
Israel 1160.71.1110 Boehringer Ingelheim Investigational Site Afula
Israel 1160.71.1121 Boehringer Ingelheim Investigational Site Afula
Israel 1160.71.1111 Boehringer Ingelheim Investigational Site Ashkelon
Israel 1160.71.1117 Boehringer Ingelheim Investigational Site Givatayim
Israel 1160.71.1112 Boehringer Ingelheim Investigational Site Hadera
Israel 1160.71.1091 Boehringer Ingelheim Investigational Site Haifa
Israel 1160.71.1113 Boehringer Ingelheim Investigational Site Haifa
Israel 1160.71.1114 Boehringer Ingelheim Investigational Site Haifa
Israel 1160.71.1116 Boehringer Ingelheim Investigational Site Haifa
Israel 1160.71.1118 Boehringer Ingelheim Investigational Site Haifa
Israel 1160.71.1105 Boehringer Ingelheim Investigational Site Holon
Israel 1160.71.1101 Boehringer Ingelheim Investigational Site Jerusalem
Israel 1160.71.1104 Boehringer Ingelheim Investigational Site Jerusalem
Israel 1160.71.1106 Boehringer Ingelheim Investigational Site Jerusalem
Israel 1160.71.1119 Boehringer Ingelheim Investigational Site Kfar Saba
Israel 1160.71.1096 Boehringer Ingelheim Investigational Site Petah Tikva
Israel 1160.71.1093 Boehringer Ingelheim Investigational Site Ramat Gan
Israel 1160.71.1094 Boehringer Ingelheim Investigational Site Ramat Gan
Israel 1160.71.1095 Boehringer Ingelheim Investigational Site Ramat Gan
Israel 1160.71.1100 Boehringer Ingelheim Investigational Site Rehovot
Israel 1160.71.1103 Boehringer Ingelheim Investigational Site Safed
Israel 1160.71.1120 Boehringer Ingelheim Investigational Site Tel Aviv
Israel 1160.71.1122 Boehringer Ingelheim Investigational Site Tel Aviv
Israel 1160.71.1107 Boehringer Ingelheim Investigational Site Tel-Aviv
Israel 1160.71.1108 Boehringer Ingelheim Investigational Site Tel-Aviv
Israel 1160.71.1109 Boehringer Ingelheim Investigational Site Tel-Aviv
Italy 1160.71.1169 Boehringer Ingelheim Investigational Site Arezzo
Italy 1160.71.1172 Boehringer Ingelheim Investigational Site Ascoli Piceno
Italy 1160.71.1170 Boehringer Ingelheim Investigational Site Sassari
Korea, Republic of 1160.71.1585 Boehringer Ingelheim Investigational Site Busan
Korea, Republic of 1160.71.1586 Boehringer Ingelheim Investigational Site Cheonan-si
Korea, Republic of 1160.71.1584 Boehringer Ingelheim Investigational Site Daegu
Korea, Republic of 1160.71.1591 Boehringer Ingelheim Investigational Site Daegu
Korea, Republic of 1160.71.1590 Boehringer Ingelheim Investigational Site Gwangju
Korea, Republic of 1160.71.1581 Boehringer Ingelheim Investigational Site Incheon
Korea, Republic of 1160.71.1582 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1160.71.1583 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1160.71.1589 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1160.71.1592 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1160.71.1593 Boehringer Ingelheim Investigational Site Seoul
Malaysia 1160.71.1291 Boehringer Ingelheim Investigational Site Kuala Lumpur
Malaysia 1160.71.1292 Boehringer Ingelheim Investigational Site Kuala Lumpur
Netherlands 1160.71.1337 Boehringer Ingelheim Investigational Site 's Hertogenbosch
Netherlands 1160.71.1344 Boehringer Ingelheim Investigational Site Almelo
Netherlands 1160.71.1331 Boehringer Ingelheim Investigational Site Amsterdam
Netherlands 1160.71.1336 Boehringer Ingelheim Investigational Site Apeldoorn
Netherlands 1160.71.1332 Boehringer Ingelheim Investigational Site Breda
Netherlands 1160.71.1349 Boehringer Ingelheim Investigational Site Den Helder
Netherlands 1160.71.1345 Boehringer Ingelheim Investigational Site Deventer
Netherlands 1160.71.1360 Boehringer Ingelheim Investigational Site Dirksland
Netherlands 1160.71.1340 Boehringer Ingelheim Investigational Site Ede
Netherlands 1160.71.1358 Boehringer Ingelheim Investigational Site Eindhoven
Netherlands 1160.71.1338 Boehringer Ingelheim Investigational Site Enschede
Netherlands 1160.71.1343 Boehringer Ingelheim Investigational Site Goes
Netherlands 1160.71.1347 Boehringer Ingelheim Investigational Site Gorinchem
Netherlands 1160.71.1333 Boehringer Ingelheim Investigational Site Groningen
Netherlands 1160.71.1361 Boehringer Ingelheim Investigational Site Heerlen
Netherlands 1160.71.1339 Boehringer Ingelheim Investigational Site Hengelo
Netherlands 1160.71.1346 Boehringer Ingelheim Investigational Site Hilversum
Netherlands 1160.71.1356 Boehringer Ingelheim Investigational Site Hoorn
Netherlands 1160.71.1359 Boehringer Ingelheim Investigational Site Maastricht
Netherlands 1160.71.1341 Boehringer Ingelheim Investigational Site Meppel
Netherlands 1160.71.1354 Boehringer Ingelheim Investigational Site Rotterdam
Netherlands 1160.71.1351 Boehringer Ingelheim Investigational Site Sneek
Netherlands 1160.71.1353 Boehringer Ingelheim Investigational Site Tiel
Netherlands 1160.71.1352 Boehringer Ingelheim Investigational Site Tilburg
Netherlands 1160.71.1350 Boehringer Ingelheim Investigational Site Veldhoven
Netherlands 1160.71.1342 Boehringer Ingelheim Investigational Site Velp
Netherlands 1160.71.1348 Boehringer Ingelheim Investigational Site Zwijndrecht
Norway 1160.71.1396 Boehringer Ingelheim Investigational Site Gjøvik
Norway 1160.71.1393 Boehringer Ingelheim Investigational Site Moss
Norway 1160.71.1395 Boehringer Ingelheim Investigational Site Nordbyhagen
Norway 1160.71.1391 Boehringer Ingelheim Investigational Site Oslo
Norway 1160.71.1397 Boehringer Ingelheim Investigational Site Oslo
Norway 1160.71.1394 Boehringer Ingelheim Investigational Site RUD
Philippines 1160.71.1422 Boehringer Ingelheim Investigational Site Ermita Manila
Philippines 1160.71.1421 Boehringer Ingelheim Investigational Site Manila
Philippines 1160.71.1424 Boehringer Ingelheim Investigational Site Pasig City
Philippines 1160.71.1423 Boehringer Ingelheim Investigational Site Quezon City
Philippines 1160.71.1425 Boehringer Ingelheim Investigational Site Quezon City
Poland 1160.71.1436 Boehringer Ingelheim Investigational Site Gdynia
Poland 1160.71.1437 Boehringer Ingelheim Investigational Site Gdynia
Poland 1160.71.1438 Boehringer Ingelheim Investigational Site Gdynia
Poland 1160.71.1433 Boehringer Ingelheim Investigational Site Pulawy
Poland 1160.71.1431 Boehringer Ingelheim Investigational Site Warsaw
Poland 1160.71.1432 Boehringer Ingelheim Investigational Site Warsaw
Poland 1160.71.1434 Boehringer Ingelheim Investigational Site Zabrze
Portugal 1160.71.1456 Boehringer Ingelheim Investigational Site Amadora
Portugal 1160.71.1451 Boehringer Ingelheim Investigational Site Carnaxide
Portugal 1160.71.1454 Boehringer Ingelheim Investigational Site Coimbra
Portugal 1160.71.1459 Boehringer Ingelheim Investigational Site Coimbra
Portugal 1160.71.1457 Boehringer Ingelheim Investigational Site Covilhã
Portugal 1160.71.1455 Boehringer Ingelheim Investigational Site Porto
Romania 1160.71.1471 Boehringer Ingelheim Investigational Site Bucharest
Romania 1160.71.1472 Boehringer Ingelheim Investigational Site Bucharest
Russian Federation 1160.71.1501 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1160.71.1503 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1160.71.1504 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1160.71.1505 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1160.71.1507 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1160.71.1508 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1160.71.1509 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1160.71.1510 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1160.71.1511 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1160.71.1512 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 1160.71.1513 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 1160.71.1514 Boehringer Ingelheim Investigational Site St. Petersburg
Singapore 1160.71.1531 Boehringer Ingelheim Investigational Site Singapore
Slovakia 1160.71.1548 Boehringer Ingelheim Investigational Site Banska Bystrica
Slovakia 1160.71.1541 Boehringer Ingelheim Investigational Site Bratislava
Slovakia 1160.71.1542 Boehringer Ingelheim Investigational Site Bratislava
Slovakia 1160.71.1543 Boehringer Ingelheim Investigational Site Bratislava
Slovakia 1160.71.1550 Boehringer Ingelheim Investigational Site Kosice
Slovakia 1160.71.1547 Boehringer Ingelheim Investigational Site Zilina
Sweden 1160.71.1633 Boehringer Ingelheim Investigational Site Göteborg
Sweden 1160.71.1627 Boehringer Ingelheim Investigational Site Malmö
Sweden 1160.71.1628 Boehringer Ingelheim Investigational Site Nässjö
Sweden 1160.71.1625 Boehringer Ingelheim Investigational Site Norrköping
Sweden 1160.71.1623 Boehringer Ingelheim Investigational Site Örebro
Sweden 1160.71.1626 Boehringer Ingelheim Investigational Site Stockholm
Sweden 1160.71.1634 Boehringer Ingelheim Investigational Site Stockholm
Sweden 1160.71.1624 Boehringer Ingelheim Investigational Site Umeå
Sweden 1160.71.1621 Boehringer Ingelheim Investigational Site Uppsala
Sweden 1160.71.1635 Boehringer Ingelheim Investigational Site Uppsala
Sweden 1160.71.1622 Boehringer Ingelheim Investigational Site Västerås
Switzerland 1160.71.1652 Boehringer Ingelheim Investigational Site Basel
Switzerland 1160.71.1655 Boehringer Ingelheim Investigational Site Bellinzona
Switzerland 1160.71.1651 Boehringer Ingelheim Investigational Site Bern
Switzerland 1160.71.1654 Boehringer Ingelheim Investigational Site Lugano
Taiwan 1160.71.1680 Boehringer Ingelheim Investigational Site Changhua
Taiwan 1160.71.1683 Boehringer Ingelheim Investigational Site Hualien
Taiwan 1160.71.1682 Boehringer Ingelheim Investigational Site Kaohsiung
Taiwan 1160.71.1679 Boehringer Ingelheim Investigational Site Taichung
Taiwan 1160.71.1681 Boehringer Ingelheim Investigational Site Tainan
Taiwan 1160.71.1671 Boehringer Ingelheim Investigational Site Taipei
Taiwan 1160.71.1672 Boehringer Ingelheim Investigational Site Taipei
Taiwan 1160.71.1673 Boehringer Ingelheim Investigational Site Taipei
Taiwan 1160.71.1674 Boehringer Ingelheim Investigational Site Taipei
Taiwan 1160.71.1675 Boehringer Ingelheim Investigational Site Taipei
Taiwan 1160.71.1676 Boehringer Ingelheim Investigational Site Taipei
Taiwan 1160.71.1677 Boehringer Ingelheim Investigational Site Taipei
Taiwan 1160.71.1678 Boehringer Ingelheim Investigational Site Taoyuan
Thailand 1160.71.1701 Boehringer Ingelheim Investigational Site Bangkok
Thailand 1160.71.1703 Boehringer Ingelheim Investigational Site Chiang Mai
Thailand 1160.71.1704 Boehringer Ingelheim Investigational Site Khon Kaen
United Kingdom 1160.71.1744 Boehringer Ingelheim Investigational Site Birmingham
United Kingdom 1160.71.1746 Boehringer Ingelheim Investigational Site Chertsey
United Kingdom 1160.71.1745 Boehringer Ingelheim Investigational Site County Armagh
United Kingdom 1160.71.1755 Boehringer Ingelheim Investigational Site Kirkcaldy, Fife
United Kingdom 1160.71.1741 Boehringer Ingelheim Investigational Site London
United Kingdom 1160.71.1742 Boehringer Ingelheim Investigational Site Newcastle upon Tyne
United Kingdom 1160.71.1751 Boehringer Ingelheim Investigational Site Newport
United Kingdom 1160.71.1752 Boehringer Ingelheim Investigational Site Northampton
United Kingdom 1160.71.1743 Boehringer Ingelheim Investigational Site Romford, Essex
United Kingdom 1160.71.1748 Boehringer Ingelheim Investigational Site York
United States 1160.71.0203 Boehringer Ingelheim Investigational Site Akron Ohio
United States 1160.71.0476 Boehringer Ingelheim Investigational Site Albany New York
United States 1160.71.0301 Boehringer Ingelheim Investigational Site Allentown Pennsylvania
United States 1160.71.0114 Boehringer Ingelheim Investigational Site Annapolis Maryland
United States 1160.71.0353 Boehringer Ingelheim Investigational Site Asheville North Carolina
United States 1160.71.0159 Boehringer Ingelheim Investigational Site Atlanta Georgia
United States 1160.71.0096 Boehringer Ingelheim Investigational Site Auburn Maine
United States 1160.71.0021 Boehringer Ingelheim Investigational Site Augusta Georgia
United States 1160.71.0129 Boehringer Ingelheim Investigational Site Austin Texas
United States 1160.71.0410 Boehringer Ingelheim Investigational Site Austin Texas
United States 1160.71.0023 Boehringer Ingelheim Investigational Site Baltimore Maryland
United States 1160.71.0047 Boehringer Ingelheim Investigational Site Baltimore Maryland
United States 1160.71.0079 Boehringer Ingelheim Investigational Site Baltimore Maryland
United States 1160.71.0186 Boehringer Ingelheim Investigational Site Baltimore Maryland
United States 1160.71.0194 Boehringer Ingelheim Investigational Site Baltimore Maryland
United States 1160.71.0144 Boehringer Ingelheim Investigational Site Baton Rouge Louisiana
United States 1160.71.0007 Boehringer Ingelheim Investigational Site Beaufort South Carolina
United States 1160.71.0255 Boehringer Ingelheim Investigational Site Bel Air Maryland
United States 1160.71.0050 Boehringer Ingelheim Investigational Site Bellingham Washington
United States 1160.71.0046 Boehringer Ingelheim Investigational Site Birmingham Alabama
United States 1160.71.0057 Boehringer Ingelheim Investigational Site Birmingham Alabama
United States 1160.71.0211 Boehringer Ingelheim Investigational Site Birmingham Alabama
United States 1160.71.0382 Boehringer Ingelheim Investigational Site Boynton Beach Florida
United States 1160.71.0056 Boehringer Ingelheim Investigational Site Brandon Florida
United States 1160.71.0278 Boehringer Ingelheim Investigational Site Bridgeport Connecticut
United States 1160.71.0113 Boehringer Ingelheim Investigational Site Bronx New York
United States 1160.71.0281 Boehringer Ingelheim Investigational Site Bronx New York
United States 1160.71.0142 Boehringer Ingelheim Investigational Site Browns Mills New Jersey
United States 1160.71.0040 Boehringer Ingelheim Investigational Site Burien Washington
United States 1160.71.0295 Boehringer Ingelheim Investigational Site Camp Hill Pennsylvania
United States 1160.71.0434 Boehringer Ingelheim Investigational Site Canal Fulton Ohio
United States 1160.71.0441 Boehringer Ingelheim Investigational Site Carmichael California
United States 1160.71.0383 Boehringer Ingelheim Investigational Site Charleston South Carolina
United States 1160.71.0080 Boehringer Ingelheim Investigational Site Charlotte North Carolina
United States 1160.71.0453 Boehringer Ingelheim Investigational Site Charlottesville Virginia
United States 1160.71.0084 Boehringer Ingelheim Investigational Site Chattanooga Tennessee
United States 1160.71.0221 Boehringer Ingelheim Investigational Site Cherry Hill New Jersey
United States 1160.71.0053 Boehringer Ingelheim Investigational Site Chesapeake Virginia
United States 1160.71.0218 Boehringer Ingelheim Investigational Site Cicero Illinois
United States 1160.71.0402 Boehringer Ingelheim Investigational Site Cincinnati Ohio
United States 1160.71.0426 Boehringer Ingelheim Investigational Site Cincinnati Ohio
United States 1160.71.0479 Boehringer Ingelheim Investigational Site Cincinnati Ohio
United States 1160.71.0169 Boehringer Ingelheim Investigational Site Clarksburg West Virginia
United States 1160.71.0296 Boehringer Ingelheim Investigational Site Clearwater Florida
United States 1160.71.0263 Boehringer Ingelheim Investigational Site Cleveland Ohio
United States 1160.71.0480 Boehringer Ingelheim Investigational Site Cleveland Ohio
United States 1160.71.0474 Boehringer Ingelheim Investigational Site Clinton Tennessee
United States 1160.71.0321 Boehringer Ingelheim Investigational Site Colorado Springs Colorado
United States 1160.71.0449 Boehringer Ingelheim Investigational Site Colorado Springs Colorado
United States 1160.71.0055 Boehringer Ingelheim Investigational Site Columbia Missouri
United States 1160.71.0398 Boehringer Ingelheim Investigational Site Columbia Maryland
United States 1160.71.0267 Boehringer Ingelheim Investigational Site Columbus Ohio
United States 1160.71.0161 Boehringer Ingelheim Investigational Site Conyers Georgia
United States 1160.71.0327 Boehringer Ingelheim Investigational Site Coral Springs Florida
United States 1160.71.0044 Boehringer Ingelheim Investigational Site Cortlandt Manor New York
United States 1160.71.0139 Boehringer Ingelheim Investigational Site Corvallis Oregon
United States 1160.71.0156 Boehringer Ingelheim Investigational Site Dallas Texas
United States 1160.71.0035 Boehringer Ingelheim Investigational Site Dayton Ohio
United States 1160.71.0376 Boehringer Ingelheim Investigational Site Daytona Beach Florida
United States 1160.71.0360 Boehringer Ingelheim Investigational Site Denver Colorado
United States 1160.71.0413 Boehringer Ingelheim Investigational Site Denver Colorado
United States 1160.71.0268 Boehringer Ingelheim Investigational Site Dubuque Iowa
United States 1160.71.0325 Boehringer Ingelheim Investigational Site Eugene Oregon
United States 1160.71.0150 Boehringer Ingelheim Investigational Site Fairview Park Ohio
United States 1160.71.0248 Boehringer Ingelheim Investigational Site Flemington New Jersey
United States 1160.71.0362 Boehringer Ingelheim Investigational Site Fort Collins Colorado
United States 1160.71.0074 Boehringer Ingelheim Investigational Site Fort Myers Florida
United States 1160.71.0377 Boehringer Ingelheim Investigational Site Fort Wayne Indiana
United States 1160.71.0315 Boehringer Ingelheim Investigational Site Fort Worth Texas
United States 1160.71.0428 Boehringer Ingelheim Investigational Site Fredericksburg Virginia
United States 1160.71.0333 Boehringer Ingelheim Investigational Site Fullerton California
United States 1160.71.0350 Boehringer Ingelheim Investigational Site Gastonia North Carolina
United States 1160.71.0062 Boehringer Ingelheim Investigational Site Germantown Tennessee
United States 1160.71.0154 Boehringer Ingelheim Investigational Site Grand Blanc Michigan
United States 1160.71.0102 Boehringer Ingelheim Investigational Site Grand Forks North Dakota
United States 1160.71.0313 Boehringer Ingelheim Investigational Site Greenville South Carolina
United States 1160.71.0482 Boehringer Ingelheim Investigational Site Guilford Connecticut
United States 1160.71.0086 Boehringer Ingelheim Investigational Site Gulfport Mississippi
United States 1160.71.0311 Boehringer Ingelheim Investigational Site Harrisonburg Virginia
United States 1160.71.0443 Boehringer Ingelheim Investigational Site Haverhill Massachusetts
United States 1160.71.0452 Boehringer Ingelheim Investigational Site Haverhill Massachusetts
United States 1160.71.0346 Boehringer Ingelheim Investigational Site Henderson Nevada
United States 1160.71.0294 Boehringer Ingelheim Investigational Site Hershey Pennsylvania
United States 1160.71.0173 Boehringer Ingelheim Investigational Site High Point North Carolina
United States 1160.71.0038 Boehringer Ingelheim Investigational Site Hot Springs Arkansas
United States 1160.71.0447 Boehringer Ingelheim Investigational Site Houston Texas
United States 1160.71.0365 Boehringer Ingelheim Investigational Site Huntington West Virginia
United States 1160.71.0288 Boehringer Ingelheim Investigational Site Indianapolis Indiana
United States 1160.71.0352 Boehringer Ingelheim Investigational Site Indianapolis Indiana
United States 1160.71.0436 Boehringer Ingelheim Investigational Site Indianapolis Indiana
United States 1160.71.0089 Boehringer Ingelheim Investigational Site Jacksonville Florida
United States 1160.71.0232 Boehringer Ingelheim Investigational Site Jacksonville Florida
United States 1160.71.0427 Boehringer Ingelheim Investigational Site Jacksonville Florida
United States 1160.71.0222 Boehringer Ingelheim Investigational Site Jamestown North Dakota
United States 1160.71.0369 Boehringer Ingelheim Investigational Site Jenkintown Pennsylvania
United States 1160.71.0370 Boehringer Ingelheim Investigational Site Johnson City Tennessee
United States 1160.71.0302 Boehringer Ingelheim Investigational Site Jonesboro Arkansas
United States 1160.71.0027 Boehringer Ingelheim Investigational Site Kalispell Montana
United States 1160.71.0257 Boehringer Ingelheim Investigational Site Kansas City Missouri
United States 1160.71.0201 Boehringer Ingelheim Investigational Site Kettering Ohio
United States 1160.71.0483 Boehringer Ingelheim Investigational Site Killeen Texas
United States 1160.71.0384 Boehringer Ingelheim Investigational Site La Jolla California
United States 1160.71.0018 Boehringer Ingelheim Investigational Site Lafayette Louisiana
United States 1160.71.0104 Boehringer Ingelheim Investigational Site Lake Havasu City Arizona
United States 1160.71.0012 Boehringer Ingelheim Investigational Site Lakeland Florida
United States 1160.71.0246 Boehringer Ingelheim Investigational Site Lancaster California
United States 1160.71.0431 Boehringer Ingelheim Investigational Site Lancaster Pennsylvania
United States 1160.71.0168 Boehringer Ingelheim Investigational Site Langhorne Pennsylvania
United States 1160.71.0205 Boehringer Ingelheim Investigational Site Lapeer Michigan
United States 1160.71.0430 Boehringer Ingelheim Investigational Site Las Vegas Nevada
United States 1160.71.0422 Boehringer Ingelheim Investigational Site Lexington Kentucky
United States 1160.71.0191 Boehringer Ingelheim Investigational Site Little Rock Arkansas
United States 1160.71.0213 Boehringer Ingelheim Investigational Site Little Rock Arkansas
United States 1160.71.0223 Boehringer Ingelheim Investigational Site Lorain Ohio
United States 1160.71.0178 Boehringer Ingelheim Investigational Site Louisville Kentucky
United States 1160.71.0397 Boehringer Ingelheim Investigational Site Louisville Kentucky
United States 1160.71.0335 Boehringer Ingelheim Investigational Site Lubbock Texas
United States 1160.71.0214 Boehringer Ingelheim Investigational Site Lyndhurst Ohio
United States 1160.71.0099 Boehringer Ingelheim Investigational Site Madison Wisconsin
United States 1160.71.0438 Boehringer Ingelheim Investigational Site Maywood Illinois
United States 1160.71.0293 Boehringer Ingelheim Investigational Site Meadowbrook Pennsylvania
United States 1160.71.0331 Boehringer Ingelheim Investigational Site Melrose Park Illinois
United States 1160.71.0070 Boehringer Ingelheim Investigational Site Merced California
United States 1160.71.0034 Boehringer Ingelheim Investigational Site Miami Florida
United States 1160.71.0072 Boehringer Ingelheim Investigational Site Milwaukee Wisconsin
United States 1160.71.0461 Boehringer Ingelheim Investigational Site Milwaukee Wisconsin
United States 1160.71.0229 Boehringer Ingelheim Investigational Site Mineola New York
United States 1160.71.0451 Boehringer Ingelheim Investigational Site Mineola New York
United States 1160.71.0202 Boehringer Ingelheim Investigational Site Minneapolis Minnesota
United States 1160.71.0115 Boehringer Ingelheim Investigational Site Mobile Alabama
United States 1160.71.0279 Boehringer Ingelheim Investigational Site Muskegon Michigan
United States 1160.71.0395 Boehringer Ingelheim Investigational Site Nashville Tennessee
United States 1160.71.0029 Boehringer Ingelheim Investigational Site Natick Massachusetts
United States 1160.71.0132 Boehringer Ingelheim Investigational Site New Iberia Louisiana
United States 1160.71.0183 Boehringer Ingelheim Investigational Site New Rochelle New York
United States 1160.71.0292 Boehringer Ingelheim Investigational Site Newport News Virginia
United States 1160.71.0364 Boehringer Ingelheim Investigational Site Normal Illinois
United States 1160.71.0394 Boehringer Ingelheim Investigational Site Norristown Pennsylvania
United States 1160.71.0109 Boehringer Ingelheim Investigational Site North Chicago Illinois
United States 1160.71.0003 Boehringer Ingelheim Investigational Site North Dartmouth Massachusetts
United States 1160.71.0210 Boehringer Ingelheim Investigational Site Northport New York
United States 1160.71.0152 Boehringer Ingelheim Investigational Site Oak Lawn Illinois
United States 1160.71.0349 Boehringer Ingelheim Investigational Site Oakland California
United States 1160.71.0478 Boehringer Ingelheim Investigational Site Oakland New Jersey
United States 1160.71.0392 Boehringer Ingelheim Investigational Site Ocean New Jersey
United States 1160.71.0016 Boehringer Ingelheim Investigational Site Oceanside California
United States 1160.71.0110 Boehringer Ingelheim Investigational Site Omaha Nebraska
United States 1160.71.0227 Boehringer Ingelheim Investigational Site Orlando Florida
United States 1160.71.0095 Boehringer Ingelheim Investigational Site Ormond Beach Florida
United States 1160.71.0310 Boehringer Ingelheim Investigational Site Owensboro Kentucky
United States 1160.71.0459 Boehringer Ingelheim Investigational Site Pasadena California
United States 1160.71.0037 Boehringer Ingelheim Investigational Site Pensacola Florida
United States 1160.71.0445 Boehringer Ingelheim Investigational Site Petoskey Michigan
United States 1160.71.0006 Boehringer Ingelheim Investigational Site Pinehurst North Carolina
United States 1160.71.0466 Boehringer Ingelheim Investigational Site Pittsburgh Pennsylvania
United States 1160.71.0137 Boehringer Ingelheim Investigational Site Port Charlotte Florida
United States 1160.71.0417 Boehringer Ingelheim Investigational Site Port Charlotte Florida
United States 1160.71.0075 Boehringer Ingelheim Investigational Site Poughkeepsie New York
United States 1160.71.0270 Boehringer Ingelheim Investigational Site Poway California
United States 1160.71.0135 Boehringer Ingelheim Investigational Site Riverside California
United States 1160.71.0274 Boehringer Ingelheim Investigational Site Rochester Hills Michigan
United States 1160.71.0198 Boehringer Ingelheim Investigational Site Rockford Illinois
United States 1160.71.0332 Boehringer Ingelheim Investigational Site Rockledge Florida
United States 1160.71.0177 Boehringer Ingelheim Investigational Site Rockville Maryland
United States 1160.71.0300 Boehringer Ingelheim Investigational Site Sacramento California
United States 1160.71.0165 Boehringer Ingelheim Investigational Site Saginaw Michigan
United States 1160.71.0220 Boehringer Ingelheim Investigational Site Salem Virginia
United States 1160.71.0073 Boehringer Ingelheim Investigational Site Salisbury Maryland
United States 1160.71.0207 Boehringer Ingelheim Investigational Site Salisbury Maryland
United States 1160.71.0269 Boehringer Ingelheim Investigational Site San Antonio Texas
United States 1160.71.0307 Boehringer Ingelheim Investigational Site San Antonio Texas
United States 1160.71.0284 Boehringer Ingelheim Investigational Site San Diego California
United States 1160.71.0285 Boehringer Ingelheim Investigational Site San Marcos Texas
United States 1160.71.0275 Boehringer Ingelheim Investigational Site Sandusky Ohio
United States 1160.71.0385 Boehringer Ingelheim Investigational Site Sarasota Florida
United States 1160.71.0208 Boehringer Ingelheim Investigational Site Sellersville Pennsylvania
United States 1160.71.0235 Boehringer Ingelheim Investigational Site South Bend Indiana
United States 1160.71.0166 Boehringer Ingelheim Investigational Site Spartanburg South Carolina
United States 1160.71.0250 Boehringer Ingelheim Investigational Site Spokane Washington
United States 1160.71.0133 Boehringer Ingelheim Investigational Site Springfield Oregon
United States 1160.71.0336 Boehringer Ingelheim Investigational Site St. Charles Missouri
United States 1160.71.0249 Boehringer Ingelheim Investigational Site St. Louis Missouri
United States 1160.71.0101 Boehringer Ingelheim Investigational Site St. Paul Minnesota
United States 1160.71.0015 Boehringer Ingelheim Investigational Site St. Petersburg Florida
United States 1160.71.0339 Boehringer Ingelheim Investigational Site St. Petersburg Florida
United States 1160.71.0002 Boehringer Ingelheim Investigational Site Statesville North Carolina
United States 1160.71.0069 Boehringer Ingelheim Investigational Site Statesville North Carolina
United States 1160.71.0224 Boehringer Ingelheim Investigational Site Suffolk Virginia
United States 1160.71.0008 Boehringer Ingelheim Investigational Site Summerville South Carolina
United States 1160.71.0256 Boehringer Ingelheim Investigational Site Tacoma Washington
United States 1160.71.0196 Boehringer Ingelheim Investigational Site Takoma Park Maryland
United States 1160.71.0187 Boehringer Ingelheim Investigational Site Towson Maryland
United States 1160.71.0020 Boehringer Ingelheim Investigational Site Troy Michigan
United States 1160.71.0414 Boehringer Ingelheim Investigational Site Troy New York
United States 1160.71.0185 Boehringer Ingelheim Investigational Site Tucson Arizona
United States 1160.71.0435 Boehringer Ingelheim Investigational Site Tulsa Oklahoma
United States 1160.71.0119 Boehringer Ingelheim Investigational Site Tupelo Mississippi
United States 1160.71.0367 Boehringer Ingelheim Investigational Site Tyler Texas
United States 1160.71.0465 Boehringer Ingelheim Investigational Site Uniontown Pennsylvania
United States 1160.71.0019 Boehringer Ingelheim Investigational Site Vero Beach Florida
United States 1160.71.0379 Boehringer Ingelheim Investigational Site Walnut Creek California
United States 1160.71.0356 Boehringer Ingelheim Investigational Site Watertown New York
United States 1160.71.0024 Boehringer Ingelheim Investigational Site Wenatchee Washington
United States 1160.71.0001 Boehringer Ingelheim Investigational Site West Des Moines Iowa
United States 1160.71.0357 Boehringer Ingelheim Investigational Site West Des Moines Iowa
United States 1160.71.0103 Boehringer Ingelheim Investigational Site Westlake Ohio
United States 1160.71.0052 Boehringer Ingelheim Investigational Site Westminster Maryland
United States 1160.71.0254 Boehringer Ingelheim Investigational Site Westwood New Jersey
United States 1160.71.0317 Boehringer Ingelheim Investigational Site Winchester Virginia
United States 1160.71.0433 Boehringer Ingelheim Investigational Site Winfield Illinois
United States 1160.71.0472 Boehringer Ingelheim Investigational Site Woodland Park New Jersey
United States 1160.71.0308 Boehringer Ingelheim Investigational Site Worcester Massachusetts
United States 1160.71.0032 Boehringer Ingelheim Investigational Site Wynnewood Pennsylvania
United States 1160.71.0067 Boehringer Ingelheim Investigational Site Wyomissing Pennsylvania
United States 1160.71.0064 Boehringer Ingelheim Investigational Site Yonkers New York
United States 1160.71.0188 Boehringer Ingelheim Investigational Site Ypsilanti Michigan

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Israel,  Italy,  Korea, Republic of,  Malaysia,  Netherlands,  Norway,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Singapore,  Slovakia,  Sweden,  Switzerland,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Major Bleeding, Annualized Rate of Subjects With Major Bleeds Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Major bleeding must have satisfied one or more of the following criteria:
Bleeding associated with a reduction in hemoglobin of at least 20 g/L
Required transfusion of at least 2 units of blood or packed cells
Symptomatic bleeding in a critical area or organ: intraocular, intraspinal, intramuscular with compartment syndrome, retroperitoneal, intra-articular, pericardial, gastrointestinal
Major bleed were classified as life-threatening if they met one or more of the following criteria:
Reduction in hemoglobin of at least 50 g/L
Transfusion of at least 4 units of blood or packed cells
Symptomatic intracranial bleeding, either subdural or intracerebral
Associated with hypotension requiring use of intravenous inotropic agents
Required surgical intervention to stop bleeding
Resulted in death
up to 43 months Yes
Secondary Stroke, Annualized Rate of Subjects With Stroke Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Stroke was an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke was categorized as ischemic or hemorrhagic or cause unknown based on computerized tomography (CT), magnetic resonance (MR) scanning or autopsy. Fatal stroke was defined as death from any cause within 30 days of stroke. Severity of stroke was assessed by modified Rankin score at discharge from hospital
up to 43 months No
Secondary Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Systemic embolism was an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts), and was to be documented by angiography, surgery, scintigraphy, or autopsy.
up to 43 months No
Secondary Pulmonary Embolism (PE), Annualized Rate of Subjects With PE Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Pulmonary Embolism was generally documented by one of the following:
an intraluminal filling defect in segmental or more proximal branches on spiral CT scan
an intraluminal filling defect or an extension of an existing defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram
a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)
inconclusive spiral CT, pulmonary angiography or lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasound or venography.
up to 43 months No
Secondary Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
a. In subjects not undergoing PCI or CABG a subject should have fulfilled at least 2 of the following: i. Typical prolonged severe chest pain or related symptoms or signs suggestive of MI. ii. Elevation of troponin or CK-MB to more than upper level of normal (ULN) or, if CK-MB was elevated at baseline, re-elevation to more than 50% increase above the previous level. iii. Development of significant Q-waves in at least 2 adjacent ECG leads. b. After percutaneous coronary intervention (within 24h). c. After coronary artery bypass grafting (within 72h). d. Silent myocardial infarction. e. Myocardial infarction could also have been demonstrated at autopsy.
up to 43 months No
Secondary Deep Vein Thrombosis, Annualized Rate of Subjects With DVT Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Deep Vein Thrombosis (DVT) was generally documented by one of the following:
abnormal compression ultrasound (CUS),
an intraluminal filling defect on venography.
up to 43 months No
Secondary Death, Annualized Rate of Subject Death Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Deaths were classified as being vascular (sudden/arrhythmic, pump failure death, or other vascular, including bleeding) or non-vascular, due to other specified causes (e.g., malignancy), or of unknown etiology.
up to 43 months No
Secondary Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. up to 43 months No
Secondary Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. up to 43 months No
Secondary Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. up to 43 months No
Secondary Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction (MI), All Cause Death and Major Bleed Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. up to 43 months No
Secondary Annualized Rate of Subjects With Minor Bleeds Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds. Minor bleeds were classified as associated with study medication discontinuation (temporary or permanent) or not.
up to 43 months No
Secondary Annualized Rate of Subjects With Any Bleeds (Major Plus Minor) Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. up to 43 months No
Secondary Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH) Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. up to 43 months No
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