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Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism

NCT ID: NCT00291330

Last Updated: 2014-06-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2564 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Brief Summary

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The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. This trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE. After achieving non-inferiority, this trial also aims to establish superiority (by means of hierarchical tests) of dabigatran over warfarin.

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Detailed Description

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Conditions

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Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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dabigatran etexilate 150 mg

twice daily

Group Type EXPERIMENTAL

dabigatran etexilate 150 mg

Intervention Type DRUG

twice daily

warfarin (INR 2-3)

prn to maintain INR (2-3)

Group Type ACTIVE_COMPARATOR

warfarin (INR 2-3)

Intervention Type DRUG

prn to maintain INR (2-3)

Interventions

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dabigatran etexilate 150 mg

twice daily

Intervention Type DRUG

warfarin (INR 2-3)

prn to maintain INR (2-3)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Acute deep vein thrombosis (DVT) of the leg involving proximal veins, and/or pulmonary embolism (PE) iin patients for whom at least 6 months of anticoagulant therapy is considered appropriate
2. Male or female, being 18 years of age or older
3. Written informed consent for study participation

Exclusion Criteria

1. Overt symptoms of VTE for longer than 2 weeks prior to enrolment
2. PE satisfying at least one of the following criteria: Haemodynamic instability, embolectomy is indicated or performed, thrombolytic therapy is indicated or performed, or suspected source of PE is other than the legs
3. Actual or anticipated use of vena cava filter
4. Contraindications to anticoagulant therapy
5. Patients who in the investigators opinion should not be treated with warfarin
6. Allergy to heparins or other alternate approved therapy used for initial treatment, warfarin or dabigatran, or to one of the excipients included in these medications
7. Patients who in the investigators judgement are perceived as having an excessive risk of bleeding
8. Known anaemia
9. Need of anticoagulant treatment for disorders other than VTE
10. Recent unstable cardiovascular disease
11. Elevated AST or ALT \> 2x ULN
12. Liver disease expected to have any potential impact on survival
13. Patients who have developed transaminase elevations upon exposure to ximelagatran
14. Severe renal impairment
15. Women who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception
16. Participation in another clinical trial with an investigational drug during the last 30 days or previous participation in this study
17. Patients considered unsuitable for inclusion by the investigator
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1160.53.01035 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Site Status

1160.53.01056 Boehringer Ingelheim Investigational Site

Hartford, Connecticut, United States

Site Status

1160.53.01044 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

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1160.53.01033 Boehringer Ingelheim Investigational Site

Sarasota, Florida, United States

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1160.53.01046 Boehringer Ingelheim Investigational Site

Sarasota, Florida, United States

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1160.53.01019 Boehringer Ingelheim Investigational Site

Augusta, Georgia, United States

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1160.53.01008 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

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1160.53.01010 Boehringer Ingelheim Investigational Site

Marietta, Georgia, United States

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1160.53.01014 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

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1160.53.01023 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

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1160.53.01029 Boehringer Ingelheim Investigational Site

Pontiac, Michigan, United States

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1160.53.01009 Boehringer Ingelheim Investigational Site

Saint Louis Park, Minnesota, United States

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1160.53.01031 Boehringer Ingelheim Investigational Site

Lebanon, New Hampshire, United States

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1160.53.01036 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

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1160.53.01025 Boehringer Ingelheim Investigational Site

Valhalla, New York, United States

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1160.53.01027 Boehringer Ingelheim Investigational Site

Chapel Hill, North Carolina, United States

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1160.53.01039 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

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1160.53.01030 Boehringer Ingelheim Investigational Site

Grand Forks, North Dakota, United States

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1160.53.01013 Boehringer Ingelheim Investigational Site

Toledo, Ohio, United States

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1160.53.01028 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

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1160.53.01052 Boehringer Ingelheim Investigational Site

Altoona, Pennsylvania, United States

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1160.53.01055 Boehringer Ingelheim Investigational Site

Summerville, South Carolina, United States

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1160.53.01017 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

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1160.53.54017 Boehringer Ingelheim Investigational Site

Adrogué, , Argentina

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1160.53.54003 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

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1160.53.54005 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

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1160.53.54006 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

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1160.53.54007 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

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1160.53.54010 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

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1160.53.61002 Boehringer Ingelheim Investigational Site

Woolloongabba, Queensland, Australia

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1160.53.61004 Boehringer Ingelheim Investigational Site

Bedford Park, South Australia, Australia

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1160.53.61003 Boehringer Ingelheim Investigational Site

Box Hill, Victoria, Australia

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1160.53.61001 Boehringer Ingelheim Investigational Site

Clayton, Victoria, Australia

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1160.53.61006 The Avenue Cardiovascular Centre

Windsor, Victoria, Australia

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1160.53.61005 Boehringer Ingelheim Investigational Site

Perth, Western Australia, Australia

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1160.53.43001 Boehringer Ingelheim Investigational Site

Graz, , Austria

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1160.53.43003 Boehringer Ingelheim Investigational Site

Innsbruck, , Austria

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1160.53.43002 Boehringer Ingelheim Investigational Site

Vienna, , Austria

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1160.53.32001 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

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1160.53.32002 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

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1160.53.32003 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

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1160.53.32007 Boehringer Ingelheim Investigational Site

Edegem, , Belgium

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1160.53.32005 Boehringer Ingelheim Investigational Site

Leuven, , Belgium

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1160.53.32004 Boehringer Ingelheim Investigational Site

Liège, , Belgium

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1160.53.55010 Boehringer Ingelheim Investigational Site

Brasília, , Brazil

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1160.53.55007 Boehringer Ingelheim Investigational Site

Campinas, , Brazil

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1160.53.55001 Boehringer Ingelheim Investigational Site

Cerqueira César - Sao Paulo, , Brazil

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1160.53.55002 Boehringer Ingelheim Investigational Site

Cerqueira César - São Paulo, , Brazil

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1160.53.55014 Boehringer Ingelheim Investigational Site

Cristo Rei - Curitiba, , Brazil

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1160.53.55011 Boehringer Ingelheim Investigational Site

Goiânia, , Brazil

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1160.53.55017 Boehringer Ingelheim Investigational Site

Paraná, , Brazil

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1160.53.55012 Boehringer Ingelheim Investigational Site

Porto Alegre, , Brazil

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1160.53.55016 Boehringer Ingelheim Investigational Site

Rio de Janeiro - RJ, , Brazil

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1160.53.55004 Boehringer Ingelheim Investigational Site

Santo André, , Brazil

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1160.53.55005 Boehringer Ingelheim Investigational Site

São José do Rio Preto, , Brazil

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1160.53.02006 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

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1160.53.02013 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

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1160.53.02021 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

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1160.53.02004 Boehringer Ingelheim Investigational Site

Saint Johns, New Brunswick, Canada

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1160.53.02001 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

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1160.53.02002 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

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1160.53.02005 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

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1160.53.02010 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

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1160.53.02022 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

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1160.53.02011 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

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1160.53.02015 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

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1160.53.02019 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

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1160.53.02008 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

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1160.53.02009 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

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1160.53.02014 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

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1160.53.02017 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

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1160.53.02020 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

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1160.53.02003 Boehringer Ingelheim Investigational Site

Sainte-Foy, Quebec, Canada

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1160.53.42001 Boehringer Ingelheim Investigational Site

Brno, , Czechia

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1160.53.42002 Boehringer Ingelheim Investigational Site

Hradec Králové, , Czechia

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1160.53.42011 Boehringer Ingelheim Investigational Site

Hranice, , Czechia

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1160.53.42009 Boehringer Ingelheim Investigational Site

Jihlava, , Czechia

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1160.53.42012 Boehringer Ingelheim Investigational Site

Liberec, , Czechia

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1160.53.42015 Boehringer Ingelheim Investigational Site

Nový Jičín, , Czechia

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1160.53.42005 Boehringer Ingelheim Investigational Site

Ostrava-Vitkovice, , Czechia

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1160.53.42004 Boehringer Ingelheim Investigational Site

Prague, , Czechia

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1160.53.42014 Boehringer Ingelheim Investigational Site

Tábor, , Czechia

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1160.53.42016 Boehringer Ingelheim Investigational Site

Teplice, , Czechia

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1160.53.42010 Boehringer Ingelheim Investigational Site

Ústí nad Labem, , Czechia

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1160.53.42007 Boehringer Ingelheim Investigational Site

Zlín, , Czechia

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1160.53.45008 Boehringer Ingelheim Investigational Site

Esbjerg, , Denmark

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1160.53.45009 Boehringer Ingelheim Investigational Site

Holbæk, , Denmark

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1160.53.45002 Boehringer Ingelheim Investigational Site

Kolding, , Denmark

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1160.53.45004 Boehringer Ingelheim Investigational Site

København NV, , Denmark

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1160.53.45007 Boehringer Ingelheim Investigational Site

København S, , Denmark

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1160.53.45006 Boehringer Ingelheim Investigational Site

Slagelse, , Denmark

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1160.53.3301A Boehringer Ingelheim Investigational Site

Brest, , France

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1160.53.3301B Boehringer Ingelheim Investigational Site

Brest, , France

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1160.53.3301C Boehringer Ingelheim Investigational Site

Brest, , France

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1160.53.3301D Boehringer Ingelheim Investigational Site

Brest, , France

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1160.53.3301E Boehringer Ingelheim Investigational Site

Brest, , France

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1160.53.3301F Boehringer Ingelheim Investigational Site

Brest, , France

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1160.53.3301H Boehringer Ingelheim Investigational Site

Brest, , France

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1160.53.3301I Boehringer Ingelheim Investigational Site

Brest, , France

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1160.53.3302A Boehringer Ingelheim Investigational Site

Lorient, , France

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1160.53.3310A Boehringer Ingelheim Investigational Site

Montpellier, , France

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1160.53.3310B Boehringer Ingelheim Investigational Site

Montpellier, , France

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1160.53.3310C Boehringer Ingelheim Investigational Site

Montpellier, , France

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1160.53.3308B Boehringer Ingelheim Investigational Site

Nancy, , France

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1160.53.3303B Boehringer Ingelheim Investigational Site

Saint-Etienne, , France

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1160.53.3303C Boehringer Ingelheim Investigational Site

Saint-Etienne, , France

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1160.53.3303D Boehringer Ingelheim Investigational Site

Saint-Etienne, , France

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1160.53.3303E Boehringer Ingelheim Investigational Site

Saint-Etienne, , France

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1160.53.3303A Boehringer Ingelheim Investigational Site

Saint-Priest-en-Jarez, , France

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1160.53.3311A Boehringer Ingelheim Investigational Site

Toulon Naval, , France

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1160.53.3311B Boehringer Ingelheim Investigational Site

Toulon Naval, , France

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1160.53.3311C Boehringer Ingelheim Investigational Site

Toulon Naval, , France

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1160.53.3311D Boehringer Ingelheim Investigational Site

Toulon Naval, , France

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1160.53.3311E Boehringer Ingelheim Investigational Site

Toulon Naval, , France

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1160.53.3308A Boehringer Ingelheim Investigational Site

Vandœuvre-lès-Nancy, , France

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1160.53.49003 Boehringer Ingelheim Investigational Site

Cologne, , Germany

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1160.53.49017 Boehringer Ingelheim Investigational Site

Dresden, , Germany

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1160.53.49018 Boehringer Ingelheim Investigational Site

Dresden, , Germany

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1160.53.49005 Boehringer Ingelheim Investigational Site

Mannheim, , Germany

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1160.53.49007 Boehringer Ingelheim Investigational Site

München, , Germany

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1160.53.49009 Boehringer Ingelheim Investigational Site

Püttlingen, , Germany

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1160.53.30001 Boehringer Ingelheim Investigational Site

Athens, , Greece

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1160.53.30005 Boehringer Ingelheim Investigational Site

Athens, , Greece

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1160.53.30006 Boehringer Ingelheim Investigational Site

Athens, , Greece

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1160.53.36001 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

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1160.53.36006 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

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1160.53.36002 Boehringer Ingelheim Investigational Site

Debrecen, , Hungary

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1160.53.36013 Boehringer Ingelheim Investigational Site

Eger, , Hungary

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1160.53.36012 Boehringer Ingelheim Investigational Site

Gyula, , Hungary

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1160.53.36004 Boehringer Ingelheim Investigational Site

Miskolc, , Hungary

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1160.53.36003 Boehringer Ingelheim Investigational Site

Pécs, , Hungary

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1160.53.36010 Boehringer Ingelheim Investigational Site

Székesfehérvár, , Hungary

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1160.53.36011 Boehringer Ingelheim Investigational Site

Szombathely, , Hungary

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1160.53.91011 Boehringer Ingelheim Investigational Site

Bangalore, , India

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1160.53.91012 Boehringer Ingelheim Investigational Site

Chennai, , India

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1160.53.91019 Boehringer Ingelheim Investigational Site

Chennai, , India

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1160.53.91013 Boehringer Ingelheim Investigational Site

Indore, , India

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1160.53.91021 Boehringer Ingelheim Investigational Site

Karna, , India

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1160.53.91022 Boehringer Ingelheim Investigational Site

Kerala, , India

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1160.53.91020 Boehringer Ingelheim Investigational Site

Ludhiana, , India

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1160.53.91007 Boehringer Ingelheim Investigational Site

Mysore, , India

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1160.53.91015 Boehringer Ingelheim Investigational Site

Nagpur, , India

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1160.53.91010 Boehringer Ingelheim Investigational Site

New Delhi, , India

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1160.53.91005 Boehringer Ingelheim Investigational Site

Pune, , India

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1160.53.91008 Boehringer Ingelheim Investigational Site

Pune, , India

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1160.53.91004 Boehringer Ingelheim Investigational Site

Vadodara, , India

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1160.53.97202 Boehringer Ingelheim Investigational Site

Afula, , Israel

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1160.53.97207 Boehringer Ingelheim Investigational Site

Ashkelon, , Israel

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1160.53.97211 Boehringer Ingelheim Investigational Site

Haifa, , Israel

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1160.53.97203 Boehringer Ingelheim Investigational Site

Holon, , Israel

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1160.53.97205 Boehringer Ingelheim Investigational Site

KfarSaba, , Israel

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1160.53.97206 Boehringer Ingelheim Investigational Site

Petah Tikva, , Israel

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1160.53.97210 Boehringer Ingelheim Investigational Site

Tel Aviv, , Israel

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1160.53.97204 Boehringer Ingelheim Investigational Site

Tel Litwinsky, , Israel

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1160.53.97201 Boehringer Ingelheim Investigational Site

Ẕerifin, , Israel

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1160.53.39003 Boehringer Ingelheim Investigational Site

Bologna, , Italy

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1160.53.39002 Boehringer Ingelheim Investigational Site

Padua, , Italy

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1160.53.39001 Boehringer Ingelheim Investigational Site

Perugia, , Italy

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1160.53.39004 Boehringer Ingelheim Investigational Site

Reggio Emilia, , Italy

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1160.53.39007 Boehringer Ingelheim Investigational Site

Vimercate, , Italy

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1160.53.39005 Boehringer Ingelheim Investigational Site

Vittorio Veneto (tv), , Italy

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1160.53.5264 Boehringer Ingelheim Investigational Site

Chihuahua City, , Mexico

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1160.53.5270 Boehringer Ingelheim Investigational Site

Culiacán, , Mexico

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1160.53.5262 Boehringer Ingelheim Investigational Site

San Luis Potosí City, , Mexico

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1160.53.31010 Boehringer Ingelheim Investigational Site

's-Hertogenbosch, , Netherlands

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1160.53.31001 Boehringer Ingelheim Investigational Site

Amersfoort, , Netherlands

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1160.53.31006 Boehringer Ingelheim Investigational Site

Amsterdam, , Netherlands

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1160.53.31013 Boehringer Ingelheim Investigational Site

Eindhoven, , Netherlands

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1160.53.31005 Boehringer Ingelheim Investigational Site

Maastricht, , Netherlands

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1160.53.31002 Boehringer Ingelheim Investigational Site

Nieuwegein, , Netherlands

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1160.53.31004 Boehringer Ingelheim Investigational Site

Rotterdam, , Netherlands

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1160.53.31009 Boehringer Ingelheim Investigational Site

Rotterdam, , Netherlands

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1160.53.64003 Boehringer Ingelheim Investigational Site

Auckland, , New Zealand

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1160.53.64004 Boehringer Ingelheim Investigational Site

Christchurch, , New Zealand

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1160.53.64002 Boehringer Ingelheim Investigational Site

Otahuhu Auckland, , New Zealand

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1160.53.64001 Boehringer Ingelheim Investigational Site

Takapuna Auckland, , New Zealand

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1160.53.47001 Boehringer Ingelheim Investigational Site

Oslo, , Norway

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1160.53.47004 Boehringer Ingelheim Investigational Site

Oslo, , Norway

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1160.53.47003 Boehringer Ingelheim Investigational Site

Rud, , Norway

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1160.53.47005 Boehringer Ingelheim Investigational Site

Trondheim, , Norway

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1160.53.35104 Boehringer Ingelheim Investigational Site

Almada, , Portugal

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1160.53.35109 Boehringer Ingelheim Investigational Site

Coimbra, , Portugal

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1160.53.35101 Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

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1160.53.35102 Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

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1160.53.35105 Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

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1160.53.07011 Boehringer Ingelheim Investigational Site

Chelyabinsk, , Russia

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1160.53.07021 Boehringer Ingelheim Investigational Site

Chelyabinsk, , Russia

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1160.53.07016 Boehringer Ingelheim Investigational Site

Krasnodar, , Russia

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1160.53.07004 Boehringer Ingelheim Investigational Site

Kursk, , Russia

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1160.53.07003 Boehringer Ingelheim Investigational Site

Moscow, , Russia

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1160.53.07010 Boehringer Ingelheim Investigational Site

Novosibirsk, , Russia

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1160.53.07020 Boehringer Ingelheim Investigational Site

Omsk, , Russia

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1160.53.07018 Boehringer Ingelheim Investigational Site

Pskov, , Russia

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1160.53.07009 Boehringer Ingelheim Investigational Site

Rostov-on-Don, , Russia

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1160.53.07023 Boehringer Ingelheim Investigational Site

Rostov-on-Don, , Russia

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1160.53.07024 Boehringer Ingelheim Investigational Site

Rostov-on-Don, , Russia

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1160.53.07025 Boehringer Ingelheim Investigational Site

Rostov-on-Don, , Russia

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1160.53.07001 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

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1160.53.07014 Boehringer Ingelheim Investigational Site

Ufa, , Russia

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1160.53.07005 Boehringer Ingelheim Investigational Site

Yaroslavl, , Russia

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1160.53.07006 Boehringer Ingelheim Investigational Site

Yaroslavl, , Russia

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1160.53.07007 Boehringer Ingelheim Investigational Site

Yekaterinburg, , Russia

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1160.53.42107 Boehringer Ingelheim Investigational Site

Banská Bystrica, , Slovakia

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1160.53.42106 Boehringer Ingelheim Investigational Site

Lučenec, , Slovakia

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1160.53.42102 Boehringer Ingelheim Investigational Site

Nitra, , Slovakia

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1160.53.42103 Boehringer Ingelheim Investigational Site

Nové Zámky, , Slovakia

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1160.53.42104 Boehringer Ingelheim Investigational Site

Žilina, , Slovakia

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1160.53.27007 Boehringer Ingelheim Investigational Site

Centurion, , South Africa

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1160.53.27001 Boehringer Ingelheim Investigational Site

Johannesburg, , South Africa

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1160.53.27002 Boehringer Ingelheim Investigational Site

Johannesburg, , South Africa

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1160.53.27004 Boehringer Ingelheim Investigational Site

Johannesburg, , South Africa

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1160.53.27006 Boehringer Ingelheim Investigational Site

Johannesburg, , South Africa

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1160.53.27009 Suite 404, Medical Centre

Pretoria, , South Africa

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1160.53.27003 Boehringer Ingelheim Investigational Site

Randburg, , South Africa

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1160.53.27008 Suite M5, Second Floor

Richards Bay, , South Africa

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1160.53.27005 Boehringer Ingelheim Investigational Site

Roodepoort, , South Africa

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1160.53.34012 Boehringer Ingelheim Investigational Site

Badalona (Barcelona), , Spain

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1160.53.34001 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

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1160.53.34002 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1160.53.34007 Boehringer Ingelheim Investigational Site

Cartagena. Murcia, , Spain

Site Status

1160.53.34003 Boehringer Ingelheim Investigational Site

Cuenca, , Spain

Site Status

1160.53.34009 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1160.53.34010 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1160.53.34004 Boehringer Ingelheim Investigational Site

Santander, , Spain

Site Status

1160.53.34005 Boehringer Ingelheim Investigational Site

Torrelavega.Santander, , Spain

Site Status

1160.53.34011 Boehringer Ingelheim Investigational Site

Valencia, , Spain

Site Status

1160.53.46002 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

Site Status

1160.53.46006 Boehringer Ingelheim Investigational Site

Jönköping, , Sweden

Site Status

1160.53.46001 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1160.53.46007 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1160.53.46008 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1160.53.46005 Boehringer Ingelheim Investigational Site

Sundsvall, , Sweden

Site Status

1160.53.46003 Boehringer Ingelheim Investigational Site

Uppsala, , Sweden

Site Status

1160.53.90003 Boehringer Ingelheim Investigational Site

Ankara, , Turkey (Türkiye)

Site Status

1160.53.90004 Boehringer Ingelheim Investigational Site

Ankara, , Turkey (Türkiye)

Site Status

1160.53.90005 Boehringer Ingelheim Investigational Site

Ankara, , Turkey (Türkiye)

Site Status

1160.53.90001 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

1160.53.90002 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

1160.53.90007 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

1160.53.90006 Boehringer Ingelheim Investigational Site

Izmir, , Turkey (Türkiye)

Site Status

1160.53.38006 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1160.53.38005 Boehringer Ingelheim Investigational Site

Vinnitsa, , Ukraine

Site Status

1160.53.38003 Boehringer Ingelheim Investigational Site

Zaporizhzhya, , Ukraine

Site Status

1160.53.44008 Boehringer Ingelheim Investigational Site

Aberdeen, , United Kingdom

Site Status

1160.53.44005 Boehringer Ingelheim Investigational Site

Headington, Oxford, , United Kingdom

Site Status

1160.53.44004 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1160.53.44009 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1160.53.44011 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1160.53.44006 Boehringer Ingelheim Investigational Site

Newcastle upon Tyne, , United Kingdom

Site Status

1160.53.44012 Boehringer Ingelheim Investigational Site

Sheffield, , United Kingdom

Site Status

Countries

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United States Argentina Australia Austria Belgium Brazil Canada Czechia Denmark France Germany Greece Hungary India Israel Italy Mexico Netherlands New Zealand Norway Portugal Russia Slovakia South Africa Spain Sweden Turkey (Türkiye) Ukraine United Kingdom

References

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Goldhaber SZ, Eriksson H, Kakkar A, Schellong S, Feuring M, Fraessdorf M, Kreuzer J, Schueler E, Schulman S. Efficacy of dabigatran versus warfarin in patients with acute venous thromboembolism in the presence of thrombophilia: Findings from RE-COVER(R), RE-COVER II, and RE-MEDY. Vasc Med. 2016 Dec;21(6):506-514. doi: 10.1177/1358863X16668588. Epub 2016 Nov 1.

Reference Type DERIVED
PMID: 27807306 (View on PubMed)

Schulman S, Kakkar AK, Goldhaber SZ, Schellong S, Eriksson H, Mismetti P, Christiansen AV, Friedman J, Le Maulf F, Peter N, Kearon C; RE-COVER II Trial Investigators. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014 Feb 18;129(7):764-72. doi: 10.1161/CIRCULATIONAHA.113.004450. Epub 2013 Dec 16.

Reference Type DERIVED
PMID: 24344086 (View on PubMed)

Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L, Brueckmann M, Fraessdorf M, Yusuf S, Schulman S. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013 Nov 19;128(21):2325-32. doi: 10.1161/CIRCULATIONAHA.113.002332. Epub 2013 Sep 30.

Reference Type DERIVED
PMID: 24081972 (View on PubMed)

Schulman S, Kearon C, Kakkar AK, Mismetti P, Schellong S, Eriksson H, Baanstra D, Schnee J, Goldhaber SZ; RE-COVER Study Group. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med. 2009 Dec 10;361(24):2342-52. doi: 10.1056/NEJMoa0906598.

Reference Type DERIVED
PMID: 19966341 (View on PubMed)

Related Links

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http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.53_Literature.pdf

Related Info

Other Identifiers

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2005-001999-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1160.53

Identifier Type: -

Identifier Source: org_study_id

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