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NCT00329238 Clinical Trial

Secondary Prevention of Venous Thrombo Embolism (VTE).

Thromboembolism Clinical Trial

— RE-MEDY  

Official title:
A Phase III, Randomised, Multicenter, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for the Secondary Prevention of Venous Thromboembolism.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00329238
Other study ID # 1160.47
Secondary ID 2005-002536-94
Status Completed
Phase Phase 3
First received May 23, 2006
Last updated May 8, 2014
Start date May 2006

Study information
Verified date December 2013
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Dept of Health and Ageing Therapeutic Goods AdminAustria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 ViennaBelgium: Federal Agency for Medicines and Health Products, FAMHPBrazil: National Health Surveillance AgencyBulgaria: Bulgarian Drug Agency, BG-1504 SofiaCanada: Health Canada, Therapeutic Products DirectorateChina: Ministry of HealthCzech 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: BfArM-Federal Authorities for Drugs and Medical DevicesGreat Britain: MHRAGreece: National Organization for Medicines (EOF) National Ethics CommitteeHungary: National Institute of Pharmacy, H-1051 BudapestIndia: Drug Control General of IndiaIsrael: Israeli Health Ministry Pharmaceutical AdministrationItaly: Comitato Etico delle Aziende Sanitarie dell'Umbria di PerugiaMexico: Comisión Federal para la Protección contra Riesgos Sanitarios COFEPRIS Federal Commission for Protection against Sanitary HazardsNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)New Zealand: Multicentre Ethics Committee/MedsafeNorway: Norwegian Medicines Agency (Statens Legemiddelverk)Poland: Registration Medicinal Product Medical Device Biocidal ProductPortugal: INFARMED, National Authority of Medicines and Health Products, IPRussia: Ministry of Healthcare and Social Development of Russian Federation, MoscowSlovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26South Africa: Medicines Control CouncilSpain: Spanish Agency for Medicines and Health ProductsSweden: Medical Products Agency Regional Ethical Review BoardTurkey: Ministry of Health Central Ethics CommitteeUkraine: Ministry of Health Care of Ukraine (MoH of Ukraine)United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous Thrombo-embolism.

Recruitment information / eligibility
Status Completed
Enrollment 2867
Est. completion date
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

Inclusion_Criteria

- Acute symptomatic deep vein thrombosis (DVT)

- Pulmonary embolism (PE) 3-12 months prior to screening, which has been documented by objective testing

Exclusion criteria:

Exclusion_Criteria

- Symptomatic DVT or PE at screening Interruption of anticoagulant therapy for 2 or more weeks during the 3-12 months of treatment for the prior VTE.

- Patients who in the investigators judgement are perceived as having an excessive risk of bleeding Elevated Aspartate aminotransferase (AST) or Alanine tranminase (ALT) > 2x ULN

- Severe renal impairment (estimated creatinine clearance <= 30 ml/min)

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Dabigatran
Dabigatran 150 mg BID (twice daily)
• Warfarin
Warfarin dosed individually to maintain INR 2.0-3.0

Locations
Country Name City State
Argentina 1160.47.54017 Boehringer Ingelheim Investigational Site Adrogué
Argentina 1160.47.54015 Boehringer Ingelheim Investigational Site Bahía Blanca
Argentina 1160.47.54001 Boehringer Ingelheim Investigational Site Capital Federal
Argentina 1160.47.54003 Boehringer Ingelheim Investigational Site Capital Federal
Argentina 1160.47.54005 Boehringer Ingelheim Investigational Site Capital Federal
Argentina 1160.47.54006 Boehringer Ingelheim Investigational Site Capital Federal
Argentina 1160.47.54007 Boehringer Ingelheim Investigational Site Capital Federal
Argentina 1160.47.54010 Boehringer Ingelheim Investigational Site Capital Federal
Argentina 1160.47.54016 Boehringer Ingelheim Investigational Site La Plata
Argentina 1160.47.54014 Boehringer Ingelheim Investigational Site Mar del Plata
Argentina 1160.47.54013 Boehringer Ingelheim Investigational Site Quilmes
Argentina 1160.47.54011 Boehringer Ingelheim Investigational Site Rosario
Argentina 1160.47.54018 Boehringer Ingelheim Investigational Site Salta
Argentina 1160.47.54012 Boehringer Ingelheim Investigational Site Santa Fe
Australia 1160.47.61004 Boehringer Ingelheim Investigational Site Bedford Park South Australia
Australia 1160.47.61003 Boehringer Ingelheim Investigational Site Box Hill Victoria
Australia 1160.47.61001 Boehringer Ingelheim Investigational Site Clayton Victoria
Australia 1160.47.61005 Boehringer Ingelheim Investigational Site Perth Western Australia
Australia 1160.47.61006 Boehringer Ingelheim Investigational Site Windsor Victoria
Australia 1160.47.61002 Princess Alexandra Hospital Wooloongabba Queensland
Austria 1160.47.43001 Boehringer Ingelheim Investigational Site Graz
Austria 1160.47.43003 Boehringer Ingelheim Investigational Site Innsbruck
Austria 1160.47.43002 Boehringer Ingelheim Investigational Site Wien
Austria 1160.47.43004 Boehringer Ingelheim Investigational Site Wien
Belgium 1160.47.32001 Boehringer Ingelheim Investigational Site Bruxelles
Belgium 1160.47.32002 Boehringer Ingelheim Investigational Site Bruxelles
Belgium 1160.47.32005 Boehringer Ingelheim Investigational Site Leuven
Belgium 1160.47.32004 Boehringer Ingelheim Investigational Site Liège
Brazil 1160.47.55010 Boehringer Ingelheim Investigational Site Brasília
Brazil 1160.47.55007 Boehringer Ingelheim Investigational Site Campinas - SP
Brazil 1160.47.55014 Boehringer Ingelheim Investigational Site Curitiba
Brazil 1160.47.55017 Boehringer Ingelheim Investigational Site Juvene - Paraná -
Brazil 1160.47.55012 Boehringer Ingelheim Investigational Site pTO aLEGRE
Brazil 1160.47.55016 Boehringer Ingelheim Investigational Site Rio de Janeiro - RJ
Brazil 1160.47.55018 Boehringer Ingelheim Investigational Site São Bernardo do Campo
Brazil 1160.47.55005 Boehringer Ingelheim Investigational Site São José do Rio Preto
Bulgaria 1160.47.35910 Boehringer Ingelheim Investigational Site Plovdiv
Bulgaria 1160.47.35908 Boehringer Ingelheim Investigational Site Rousse
Bulgaria 1160.47.35901 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1160.47.35903 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1160.47.35904 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1160.47.35906 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1160.47.35907 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1160.47.35905 Boehringer Ingelheim Investigational Site Varna
Canada 1160.47.02006 Boehringer Ingelheim Investigational Site Edmonton Alberta
Canada 1160.47.02013 Boehringer Ingelheim Investigational Site Edmonton Alberta
Canada 1160.47.02001 Boehringer Ingelheim Investigational Site Halifax Nova Scotia
Canada 1160.47.02002 Boehringer Ingelheim Investigational Site Hamilton Ontario
Canada 1160.47.02005 Boehringer Ingelheim Investigational Site Hamilton Ontario
Canada 1160.47.02010 Boehringer Ingelheim Investigational Site Hamilton Ontario
Canada 1160.47.02022 Boehringer Ingelheim Investigational Site Hamilton Ontario
Canada 1160.47.02008 Boehringer Ingelheim Investigational Site Montreal Quebec
Canada 1160.47.02009 Boehringer Ingelheim Investigational Site Montreal Quebec
Canada 1160.47.02014 Boehringer Ingelheim Investigational Site Montreal Quebec
Canada 1160.47.02017 Boehringer Ingelheim Investigational Site Montreal Quebec
Canada 1160.47.02015 Boehringer Ingelheim Investigational Site Ottawa Ontario
Canada 1160.47.02004 Boehringer Ingelheim Investigational Site Saint Johns New Brunswick
Canada 1160.47.02019 Boehringer Ingelheim Investigational Site Toronto Ontario
Canada 1160.47.02021 Boehringer Ingelheim Investigational Site Victoria British Columbia
China 1160.47.86001 Boehringer Ingelheim Investigational Site Beijing
China 1160.47.86015 Boehringer Ingelheim Investigational Site Beijing
China 1160.47.86014 Boehringer Ingelheim Investigational Site Chengdu
China 1160.47.86012 Boehringer Ingelheim Investigational Site Guangzhou
China 1160.47.86009 Boehringer Ingelheim Investigational Site Hangzhou
China 1160.47.86010 Boehringer Ingelheim Investigational Site Hangzhou
China 1160.47.86013 Boehringer Ingelheim Investigational Site Nanjing
China 1160.47.86002 Boehringer Ingelheim Investigational Site Shanghai
China 1160.47.86003 Boehringer Ingelheim Investigational Site Shanghai
China 1160.47.86004 Boehringer Ingelheim Investigational Site Shanghai
China 1160.47.86005 Boehringer Ingelheim Investigational Site Shanghai
China 1160.47.86006 Boehringer Ingelheim Investigational Site Shanghai
China 1160.47.86007 Boehringer Ingelheim Investigational Site Shanghai
China 1160.47.86016 Boehringer Ingelheim Investigational Site Shanghai
China 1160.47.86011 Boehringer Ingelheim Investigational Site Shijiazhuang
Czech Republic 1160.47.42001 Boehringer Ingelheim Investigational Site Brno
Czech Republic 1160.47.42002 Boehringer Ingelheim Investigational Site Hradec Kralove
Czech Republic 1160.47.42011 Boehringer Ingelheim Investigational Site Hranice
Czech Republic 1160.47.42012 Boehringer Ingelheim Investigational Site Liberec
Czech Republic 1160.47.42015 Boehringer Ingelheim Investigational Site Novy Jicin
Czech Republic 1160.47.42005 Boehringer Ingelheim Investigational Site Ostrava-Vitkovice
Czech Republic 1160.47.42004 Boehringer Ingelheim Investigational Site Praha 2
Czech Republic 1160.47.42014 Boehringer Ingelheim Investigational Site Tabor
Czech Republic 1160.47.42010 Boehringer Ingelheim Investigational Site Usti nad Labem
Czech Republic 1160.47.42007 Boehringer Ingelheim Investigational Site Zlin
Denmark 1160.47.45008 Boehringer Ingelheim Investigational Site Esbjerg
Denmark 1160.47.45009 Boehringer Ingelheim Investigational Site Holbæk
Denmark 1160.47.45004 Boehringer Ingelheim Investigational Site København NV
Denmark 1160.47.45007 Boehringer Ingelheim Investigational Site København S
Denmark 1160.47.45002 Boehringer Ingelheim Investigational Site Kolding
Denmark 1160.47.45006 Boehringer Ingelheim Investigational Site Slagelse
Finland 1160.47.35804 Boehringer Ingelheim Investigational Site Espoo
Finland 1160.47.35801 Boehringer Ingelheim Investigational Site Helsinki
Finland 1160.47.35802 Boehringer Ingelheim Investigational Site Jyväskylä
Finland 1160.47.35805 Boehringer Ingelheim Investigational Site Kuopio
Finland 1160.47.35803 Boehringer Ingelheim Investigational Site Tampere
France 1160.47.3301A Boehringer Ingelheim Investigational Site Brest Cedex
France 1160.47.3301B Boehringer Ingelheim Investigational Site Brest Cedex
France 1160.47.3301C Boehringer Ingelheim Investigational Site Brest Cedex
France 1160.47.3301D Boehringer Ingelheim Investigational Site Brest Cedex
France 1160.47.3301E Boehringer Ingelheim Investigational Site Brest Cedex
France 1160.47.3301F Boehringer Ingelheim Investigational Site Brest Cedex
France 1160.47.3301H Boehringer Ingelheim Investigational Site Brest Cedex
France 1160.47.3301I Boehringer Ingelheim Investigational Site Brest Cedex
France 1160.47.3302A Boehringer Ingelheim Investigational Site Lorient
France 1160.47.3303A Boehringer Ingelheim Investigational Site St Etienne Cedex 2
France 1160.47.3303B Boehringer Ingelheim Investigational Site St Etienne Cedex 2
France 1160.47.3303C Boehringer Ingelheim Investigational Site St Etienne Cedex 2
France 1160.47.3303D Boehringer Ingelheim Investigational Site St Etienne Cedex 2
France 1160.47.3308A Boehringer Ingelheim Investigational Site Vandoeuvre les Nancy
Germany 1160.47.49017 Boehringer Ingelheim Investigational Site Dresden
Germany 1160.47.49018 Boehringer Ingelheim Investigational Site Dresden
Germany 1160.47.49003 Boehringer Ingelheim Investigational Site Köln
Germany 1160.47.49005 Boehringer Ingelheim Investigational Site Mannheim
Germany 1160.47.49006 Boehringer Ingelheim Investigational Site Mannheim
Germany 1160.47.49007 Boehringer Ingelheim Investigational Site München
Germany 1160.47.49008 Boehringer Ingelheim Investigational Site München
Germany 1160.47.49009 Boehringer Ingelheim Investigational Site Püttlingen
Greece 1160.47.30001 Boehringer Ingelheim Investigational Site Athens
Greece 1160.47.30006 Boehringer Ingelheim Investigational Site Athens
Greece 1160.47.30007 Boehringer Ingelheim Investigational Site Athens
Greece 1160.47.30009 Boehringer Ingelheim Investigational Site Athens
Hungary 1160.47.36001 Boehringer Ingelheim Investigational Site Budapest
Hungary 1160.47.36006 Boehringer Ingelheim Investigational Site Budapest
Hungary 1160.47.36007 Boehringer Ingelheim Investigational Site Budapest
Hungary 1160.47.36002 Boehringer Ingelheim Investigational Site Debrecen
Hungary 1160.47.36012 Boehringer Ingelheim Investigational Site Gyula
Hungary 1160.47.36004 Boehringer Ingelheim Investigational Site Miskolc
Hungary 1160.47.36003 Boehringer Ingelheim Investigational Site Pecs
Hungary 1160.47.36010 Boehringer Ingelheim Investigational Site Székesfehérvár
Hungary 1160.47.36011 Boehringer Ingelheim Investigational Site Szombathely
India 1160.47.91002 Boehringer Ingelheim Investigational Site Ahmedabad
India 1160.47.91011 Boehringer Ingelheim Investigational Site Bangalore
India 1160.47.91015 Boehringer Ingelheim Investigational Site Bangalore
India 1160.47.91012 Boehringer Ingelheim Investigational Site Chennai
India 1160.47.91017 Boehringer Ingelheim Investigational Site Chennai
India 1160.47.91009 Boehringer Ingelheim Investigational Site Madurai
India 1160.47.91007 Boehringer Ingelheim Investigational Site Mysore
India 1160.47.91003 Boehringer Ingelheim Investigational Site New Delhi
India 1160.47.91006 Boehringer Ingelheim Investigational Site new Delhi
India 1160.47.91010 Boehringer Ingelheim Investigational Site New Delhi
India 1160.47.91001 Boehringer Ingelheim Investigational Site Pune
India 1160.47.91005 Boehringer Ingelheim Investigational Site Pune
India 1160.47.91008 Boehringer Ingelheim Investigational Site Pune
India 1160.47.91014 Boehringer Ingelheim Investigational Site Trivandrum
India 1160.47.91004 Boehringer Ingelheim Investigational Site Vadodara
Israel 1160.47.97202 Boehringer Ingelheim Investigational Site Afula
Israel 1160.47.97207 Boehringer Ingelheim Investigational Site Ashkelon
Israel 1160.47.97211 Boehringer Ingelheim Investigational Site Haifa
Israel 1160.47.97203 Boehringer Ingelheim Investigational Site Holon
Israel 1160.47.97205 Boehringer Ingelheim Investigational Site Kfar Saba
Israel 1160.47.97206 Boehringer Ingelheim Investigational Site Petach Tikva
Israel 1160.47.97208 Boehringer Ingelheim Investigational Site Rehovot
Israel 1160.47.97210 Boehringer Ingelheim Investigational Site Tel Aviv
Israel 1160.47.97204 Boehringer Ingelheim Investigational Site Tel Hashomer
Israel 1160.47.97201 Boehringer Ingelheim Investigational Site Zerifin
Italy 1160.47.39003 Boehringer Ingelheim Investigational Site Bologna
Italy 1160.47.39004 Boehringer Ingelheim Investigational Site Cremona
Italy 1160.47.39006 Boehringer Ingelheim Investigational Site Genova
Italy 1160.47.39008 Boehringer Ingelheim Investigational Site Milano
Italy 1160.47.39007 Boehringer Ingelheim Investigational Site Reggio Emilia
Italy 1160.47.39009 Boehringer Ingelheim Investigational Site Udine
Italy 1160.47.39005 Boehringer Ingelheim Investigational Site Vittorio Veneto
Mexico 1160.47.52036 Boehringer Ingelheim Investigational Site Chihuahua
Mexico 1160.47.52039 Boehringer Ingelheim Investigational Site Culiacan
Mexico 1160.47.52030 Boehringer Ingelheim Investigational Site Guadalajara, Jal.
Mexico 1160.47.52027 Boehringer Ingelheim Investigational Site Monterrey
Mexico 1160.47.52034 Boehringer Ingelheim Investigational Site San Luis Potosí
Netherlands 1160.47.31001 Boehringer Ingelheim Investigational Site Amersfoort
Netherlands 1160.47.31006 Boehringer Ingelheim Investigational Site Amsterdam
Netherlands 1160.47.31007 Boehringer Ingelheim Investigational Site Amsterdam
Netherlands 1160.47.31010 Boehringer Ingelheim Investigational Site Den Bosch
Netherlands 1160.47.31014 Boehringer Ingelheim Investigational Site Heerlen
Netherlands 1160.47.31005 Boehringer Ingelheim Investigational Site Maastricht
Netherlands 1160.47.31004 Boehringer Ingelheim Investigational Site Rotterdam
Netherlands 1160.47.31009 Boehringer Ingelheim Investigational Site Rotterdam
New Zealand 1160.47.64004 Boehringer Ingelheim Investigational Site Christchurch
New Zealand 1160.47.64003 Boehringer Ingelheim Investigational Site Grafton
New Zealand 1160.47.64002 Boehringer Ingelheim Investigational Site Otahuhu
New Zealand 1160.47.64001 Boehringer Ingelheim Investigational Site Takapuna Auckland 9
Norway 1160.47.47001 Boehringer Ingelheim Investigational Site Oslo
Norway 1160.47.47004 Boehringer Ingelheim Investigational Site Oslo
Norway 1160.47.47003 Boehringer Ingelheim Investigational Site Rud
Norway 1160.47.47005 Boehringer Ingelheim Investigational Site Trondheim
Poland 1160.47.48004 Boehringer Ingelheim Investigational Site Kielce
Poland 1160.47.48005 Boehringer Ingelheim Investigational Site Krakow
Poland 1160.47.48007 Boehringer Ingelheim Investigational Site Krakow
Poland 1160.47.48003 Boehringer Ingelheim Investigational Site Poznan
Poland 1160.47.48006 Boehringer Ingelheim Investigational Site Warsaw
Portugal 1160.47.35104 Boehringer Ingelheim Investigational Site Almada
Portugal 1160.47.35109 Boehringer Ingelheim Investigational Site Coimbra
Portugal 1160.47.35107 Boehringer Ingelheim Investigational Site Covilhã
Portugal 1160.47.35101 Boehringer Ingelheim Investigational Site Lisboa
Portugal 1160.47.35102 Boehringer Ingelheim Investigational Site Lisboa
Portugal 1160.47.35105 Boehringer Ingelheim Investigational Site Lisboa
Russian Federation 1160.47.07022 Boehringer Ingelheim Investigational Site Belgorod
Russian Federation 1160.47.07011 Boehringer Ingelheim Investigational Site Chelyabinsk
Russian Federation 1160.47.07021 Boehringer Ingelheim Investigational Site Chelyabinsk
Russian Federation 1160.47.07007 Boehringer Ingelheim Investigational Site Ekaterinburg
Russian Federation 1160.47.07016 Boehringer Ingelheim Investigational Site Krasnodar
Russian Federation 1160.47.07004 Boehringer Ingelheim Investigational Site Kursk
Russian Federation 1160.47.07010 Boehringer Ingelheim Investigational Site Novosibirsk
Russian Federation 1160.47.07020 Boehringer Ingelheim Investigational Site Omsk
Russian Federation 1160.47.07018 Boehringer Ingelheim Investigational Site Pskov
Russian Federation 1160.47.07009 Boehringer Ingelheim Investigational Site Rostov-na-Donu
Russian Federation 1160.47.07023 Boehringer Ingelheim Investigational Site Rostov-na-Donu
Russian Federation 1160.47.07024 Boehringer Ingelheim Investigational Site Rostov-na-Donu
Russian Federation 1160.47.07025 Boehringer Ingelheim Investigational Site Rostov-na-Donu
Russian Federation 1160.47.07001 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 1160.47.07002 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 1160.47.07017 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 1160.47.07019 Boehringer Ingelheim Investigational Site Tyumen
Russian Federation 1160.47.07014 Boehringer Ingelheim Investigational Site Ufa
Russian Federation 1160.47.07005 Boehringer Ingelheim Investigational Site Yaroslavl
Russian Federation 1160.47.07006 Boehringer Ingelheim Investigational Site Yaroslavl
Slovakia 1160.47.42107 Boehringer Ingelheim Investigational Site Banska Bystrica
Slovakia 1160.47.42106 Boehringer Ingelheim Investigational Site Lucenec
Slovakia 1160.47.42102 Boehringer Ingelheim Investigational Site Nitra
Slovakia 1160.47.42103 Boehringer Ingelheim Investigational Site Nove Zamky
Slovakia 1160.47.42104 Boehringer Ingelheim Investigational Site Zilina
South Africa 1160.47.27001 Boehringer Ingelheim Investigational Site Johannesburg
South Africa 1160.47.27002 Boehringer Ingelheim Investigational Site Johannesburg
South Africa 1160.47.27006 Boehringer Ingelheim Investigational Site Johannesburg
South Africa 1160.47.27007 Pretoria
South Africa 1160.47.27003 Boehringer Ingelheim Investigational Site Randburg
South Africa 1160.47.27005 Boehringer Ingelheim Investigational Site Roodepoort
Spain 1160.47.34006 Boehringer Ingelheim Investigational Site Alicante
Spain 1160.47.34012 Boehringer Ingelheim Investigational Site Badalona (Barcelona)
Spain 1160.47.34001 Boehringer Ingelheim Investigational Site Barcelona
Spain 1160.47.34002 Boehringer Ingelheim Investigational Site Barcelona
Spain 1160.47.34007 Boehringer Ingelheim Investigational Site Cartagena. Murcia
Spain 1160.47.34003 Boehringer Ingelheim Investigational Site Cuenca
Spain 1160.47.34009 Boehringer Ingelheim Investigational Site Madrid
Spain 1160.47.34004 Boehringer Ingelheim Investigational Site Santander
Spain 1160.47.34011 Boehringer Ingelheim Investigational Site Valencia
Sweden 1160.47.46002 Boehringer Ingelheim Investigational Site Göteborg
Sweden 1160.47.46006 Boehringer Ingelheim Investigational Site Jönköping
Sweden 1160.47.46001 Boehringer Ingelheim Investigational Site Stockholm
Sweden 1160.47.46007 Boehringer Ingelheim Investigational Site Stockholm
Sweden 1160.47.46008 Boehringer Ingelheim Investigational Site Stockholm
Sweden 1160.47.46005 Boehringer Ingelheim Investigational Site Sundsvall
Sweden 1160.47.46003 Boehringer Ingelheim Investigational Site Uppsala
Turkey 1160.47.90003 Boehringer Ingelheim Investigational Site Ankara
Turkey 1160.47.90004 Boehringer Ingelheim Investigational Site Ankara
Turkey 1160.47.90005 Boehringer Ingelheim Investigational Site Ankara
Turkey 1160.47.90001 Boehringer Ingelheim Investigational Site Istanbul
Turkey 1160.47.90002 Boehringer Ingelheim Investigational Site Istanbul
Turkey 1160.47.90007 Boehringer Ingelheim Investigational Site Istanbul
Turkey 1160.47.90006 Boehringer Ingelheim Investigational Site Izmir
Ukraine 1160.47.38002 Boehringer Ingelheim Investigational Site Kharkov
Ukraine 1160.47.38006 Boehringer Ingelheim Investigational Site Kiev
Ukraine 1160.47.38005 Boehringer Ingelheim Investigational Site Vinnitsa
Ukraine 1160.47.38003 Boehringer Ingelheim Investigational Site Zaporozhye
United Kingdom 1160.47.44005 Boehringer Ingelheim Investigational Site Headington, Oxford
United Kingdom 1160.47.44009 Boehringer Ingelheim Investigational Site London
United Kingdom 1160.47.44011 Boehringer Ingelheim Investigational Site London
United Kingdom 1160.47.44006 Boehringer Ingelheim Investigational Site Newcastle upon Tyne
United Kingdom 1160.47.44012 Boehringer Ingelheim Investigational Site Sheffield
United States 1160.47.01036 Boehringer Ingelheim Investigational Site Albuquerque New Mexico
United States 1160.47.01052 Boehringer Ingelheim Investigational Site Altoona Pennsylvania
United States 1160.47.01019 Boehringer Ingelheim Investigational Site Augusta Georgia
United States 1160.47.01014 Boehringer Ingelheim Investigational Site Baltimore Maryland
United States 1160.47.01027 Boehringer Ingelheim Investigational Site Chapel Hill North Carolina
United States 1160.47.01044 Boehringer Ingelheim Investigational Site Clearwater Florida
United States 1160.47.01008 Boehringer Ingelheim Investigational Site Decatur Georgia
United States 1160.47.01023 Boehringer Ingelheim Investigational Site Detroit Michigan
United States 1160.47.01030 Boehringer Ingelheim Investigational Site Grand Forks North Dakota
United States 1160.47.01056 Boehringer Ingelheim Investigational Site Hartford Connecticut
United States 1160.47.01031 Boehringer Ingelheim Investigational Site Lebanon New Hampshire
United States 1160.47.01035 Boehringer Ingelheim Investigational Site Mobile Alabama
United States 1160.47.01017 Boehringer Ingelheim Investigational Site Richmond Virginia
United States 1160.47.01018 Boehringer Ingelheim Investigational Site Roxbury Crossing Massachusetts
United States 1160.47.01009 Boehringer Ingelheim Investigational Site St. Louis Park Minnesota
United States 1160.47.01055 Boehringer Ingelheim Investigational Site Summerville South Carolina
United States 1160.47.01013 Boehringer Ingelheim Investigational Site Toledo Ohio
United States 1160.47.01039 Boehringer Ingelheim Investigational Site Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Russian Federation,  Slovakia,  South Africa,  Spain,  Sweden,  Turkey,  Ukraine,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Composite of Recurrent VTE or VTE Death at 36 Months Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE. 36 months No
Primary Composite of Recurrent VTE or VTE Death at 18 Months Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE. 18 months No
Secondary Composite of Recurrent VTE or All Cause Death at 36 Months Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. 36 months No
Secondary Composite of Recurrent VTE or All Cause Death at 18 Months Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. 18 months No
Secondary Deep Vein Thrombosis (DVT) at 36 Months Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation. 36 months No
Secondary DVT at 18 Months Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation. 18 months No
Secondary Symptomatic Pulmonary Embolism (PE) at 36 Months Symptomatic pulmonary embolism (PE) at 36 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography. 36 months No
Secondary Symptomatic Pulmonary Embolism (PE) at 18 Months Symptomatic pulmonary embolism (PE) at 18 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography. 18 months No
Secondary Deaths Related to VTE at 36 Months Deaths related to VTE (i.e. fatal PE) at 36 Months. Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way. 36 months No
Secondary Deaths Related to VTE at 18 Months Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way. 18 months No
Secondary Deaths of All Causes at 36 Months Deaths of all causes at 36 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments. 36 months No
Secondary Deaths of All Causes at 18 Months Deaths of all causes at 18 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments. 18 months No
Secondary Number of Participants With Bleeding Events MBE (major bleeding event) if it fulfilled at least one of the following criteria
Fatal bleeding
Symptomatic bleeding in a critical area or organ.
Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells.
Minor bleeding event was any bleeding that did not fulfil any of the criteria for MBEs
CRBE (clinically relevant bleeding event) if it is a minor bleeding events which fulfilled at least one of the following criteria
Spontaneous skin haematoma =25 cm2
Spontaneous nose bleed >5 min duration
Macroscopic haematuria, either spontaneous or, if associated with an intervention, lasting >24 h
Spontaneous rectal bleeding
Gingival bleeding >5 min
Bleeding leading to hospitalisation or requiring surgical treatment
Bleeding leading to a transfusion of <2 units of whole blood or red cells
Any other bleeding event considered clinically relevant by the investigator		 first intake of study drug until 6 days following last intake of study drug Yes
Secondary Laboratory Analysis Patients with LFT (liver function tests) increases of possible clinical significance during treatment. Increases of possible clinical significance were defined as: =3 x ULN (AST, ALT), =2 x ULN (AP), and =2 mg/dL (total bilirubin). Only patients with a baseline value which was not of possible clinical significance (or without any baseline value) could have a PCSA (Possible clinically significant abnormality). 18 months + 30 days follow up No
Secondary Number of Participants With Definite Acute Coronary Syndrome (ACS) All suspected ACS occurring during the trial were to be recorded on the CRF and were to be centrally adjudicated by an independent ACS/AC in a treatment-blinded manner. day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination No
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