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Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE (RE-SONATE)

Primary Purpose

Venous Thromboembolism

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
dabigatran etexilate 150 mg twice daily (BID)
matching placebo twice daily (BID)
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Patients with confirmed symptomatic PE or proximal DVT of the leg(s) who have been treated for 6 to 18 months with therapeutic dosages (intended INR between 2-3) of an oral VKA (e.g. warfarin, acenocoumarol, phenprocoumon, or fluindione) or RE-COVER study medication up to the moment of screening for the current study.
  2. Written informed consent

Exclusion criteria:

  1. Younger then 18 years of age
  2. Indication for VKA other than DVT and/or PE
  3. Patients in whom anticoagulant treatment for their index PE or DVT should be continued
  4. Active liver disease or liver disease decreasing survival (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN
  5. Creatinine clearance < 30 ml/min
  6. Acute bacterial endocarditis
  7. Active bleeding or high risk for bleeding.
  8. Uncontrolled hypertension (investigators judgement)
  9. Intake of another experimental drug within the 30 days prior to randomization into the study
  10. Life expectancy <6 months
  11. Childbearing potential without proper contraceptive measures*, pregnancy or breast feeding

Sites / Locations

  • 1160.63.01025 Boehringer Ingelheim Investigational Site
  • 1160.63.01023 Boehringer Ingelheim Investigational Site
  • 1160.63.01002 Boehringer Ingelheim Investigational Site
  • 1160.63.01014 Boehringer Ingelheim Investigational Site
  • 1160.63.01003 Boehringer Ingelheim Investigational Site
  • 1160.63.01030 Boehringer Ingelheim Investigational Site
  • 1160.63.01022 Boehringer Ingelheim Investigational Site
  • 1160.63.01044 Boehringer Ingelheim Investigational Site
  • 1160.63.01017 Boehringer Ingelheim Investigational Site
  • 1160.63.01004 Boehringer Ingelheim Investigational Site
  • 1160.63.01016 Boehringer Ingelheim Investigational Site
  • 1160.63.01037 Boehringer Ingelheim Investigational Site
  • 1160.63.01019 Boehringer Ingelheim Investigational Site
  • 1160.63.01032 Boehringer Ingelheim Investigational Site
  • 1160.63.01001 Boehringer Ingelheim Investigational Site
  • 1160.63.01024 Boehringer Ingelheim Investigational Site
  • 1160.63.01005 Boehringer Ingelheim Investigational Site
  • 1160.63.01020 Boehringer Ingelheim Investigational Site
  • 1160.63.01011 Boehringer Ingelheim Investigational Site
  • 1160.63.01007 Boehringer Ingelheim Investigational Site
  • 1160.63.01035 Boehringer Ingelheim Investigational Site
  • 1160.63.61002 Boehringer Ingelheim Investigational Site
  • 1160.63.61003 Boehringer Ingelheim Investigational Site
  • 1160.63.61001 Boehringer Ingelheim Investigational Site
  • 1160.63.61004 Boehringer Ingelheim Investigational Site
  • 1160.63.43005 Boehringer Ingelheim Investigational Site
  • 1160.63.43006 Boehringer Ingelheim Investigational Site
  • 1160.63.43001 Boehringer Ingelheim Investigational Site
  • 1160.63.43002 Boehringer Ingelheim Investigational Site
  • 1160.63.43004 Boehringer Ingelheim Investigational Site
  • 1160.63.32005 Boehringer Ingelheim Investigational Site
  • 1160.63.32004 Boehringer Ingelheim Investigational Site
  • 1160.63.32003 Boehringer Ingelheim Investigational Site
  • 1160.63.32001 Boehringer Ingelheim Investigational Site
  • 1160.63.32002 Boehringer Ingelheim Investigational Site
  • 1160.63.02013 Boehringer Ingelheim Investigational Site
  • 1160.63.02004 Boehringer Ingelheim Investigational Site
  • 1160.63.02005 Boehringer Ingelheim Investigational Site
  • 1160.63.02020 Boehringer Ingelheim Investigational Site
  • 1160.63.42004 Boehringer Ingelheim Investigational Site
  • 1160.63.42003 Boehringer Ingelheim Investigational Site
  • 1160.63.42008 Boehringer Ingelheim Investigational Site
  • 1160.63.42012 Boehringer Ingelheim Investigational Site
  • 1160.63.42010 Boehringer Ingelheim Investigational Site
  • 1160.63.42011 Boehringer Ingelheim Investigational Site
  • 1160.63.42009 Boehringer Ingelheim Investigational Site
  • 1160.63.42002 Boehringer Ingelheim Investigational Site
  • 1160.63.42001 Boehringer Ingelheim Investigational Site
  • 1160.63.42006 Boehringer Ingelheim Investigational Site
  • 1160.63.42005 Boehringer Ingelheim Investigational Site
  • 1160.63.42007 Boehringer Ingelheim Investigational Site
  • 1160.63.42013 Boehringer Ingelheim Investigational Site
  • 1160.63.42014 Boehringer Ingelheim Investigational Site
  • 1160.63.37202 Boehringer Ingelheim Investigational Site
  • 1160.63.37203 Boehringer Ingelheim Investigational Site
  • 1160.63.37201 Boehringer Ingelheim Investigational Site
  • 1160.63.49013 Boehringer Ingelheim Investigational Site
  • 1160.63.49017 Boehringer Ingelheim Investigational Site
  • 1160.63.49018 Boehringer Ingelheim Investigational Site
  • 1160.63.49014 Boehringer Ingelheim Investigational Site
  • 1160.63.49011 Boehringer Ingelheim Investigational Site
  • 1160.63.49005 Boehringer Ingelheim Investigational Site
  • 1160.63.49010 Boehringer Ingelheim Investigational Site
  • 1160.63.49007 Boehringer Ingelheim Investigational Site
  • 1160.63.49009 Boehringer Ingelheim Investigational Site
  • 1160.63.39006 Boehringer Ingelheim Investigational Site
  • 1160.63.39015 Boehringer Ingelheim Investigational Site
  • 1160.63.39019 Boehringer Ingelheim Investigational Site
  • 1160.63.39003 Boehringer Ingelheim Investigational Site
  • 1160.63.39008 Boehringer Ingelheim Investigational Site
  • 1160.63.39011 Boehringer Ingelheim Investigational Site
  • 1160.63.39009 Boehringer Ingelheim Investigational Site
  • 1160.63.39004 Boehringer Ingelheim Investigational Site
  • 1160.63.39010 Boehringer Ingelheim Investigational Site
  • 1160.63.39020 Boehringer Ingelheim Investigational Site
  • 1160.63.39022 Boehringer Ingelheim Investigational Site
  • 1160.63.39001 Boehringer Ingelheim Investigational Site
  • 1160.63.39007 Boehringer Ingelheim Investigational Site
  • 1160.63.39012 Boehringer Ingelheim Investigational Site
  • 1160.63.39017 Boehringer Ingelheim Investigational Site
  • 1160.63.39014 Boehringer Ingelheim Investigational Site
  • 1160.63.39002 Boehringer Ingelheim Investigational Site
  • 1160.63.39016 Boehringer Ingelheim Investigational Site
  • 1160.63.82010 Boehringer Ingelheim Investigational Site
  • 1160.63.82003 Boehringer Ingelheim Investigational Site
  • 1160.63.82005 Boehringer Ingelheim Investigational Site
  • 1160.63.82001 Boehringer Ingelheim Investigational Site
  • 1160.63.82004 Boehringer Ingelheim Investigational Site
  • 1160.63.82006 Boehringer Ingelheim Investigational Site
  • 1160.63.82008 Boehringer Ingelheim Investigational Site
  • 1160.63.82011 Boehringer Ingelheim Investigational Site
  • 1160.63.82007 Boehringer Ingelheim Investigational Site
  • 1160.63.37101 Boehringer Ingelheim Investigational Site
  • 1160.63.37102 Boehringer Ingelheim Investigational Site
  • 1160.63.37002 Boehringer Ingelheim Investigational Site
  • 1160.63.37001 Boehringer Ingelheim Investigational Site
  • 1160.63.31010 Boehringer Ingelheim Investigational Site
  • 1160.63.31006 Boehringer Ingelheim Investigational Site
  • 1160.63.31007 Boehringer Ingelheim Investigational Site
  • 1160.63.31011 Boehringer Ingelheim Investigational Site
  • 1160.63.31012 Boehringer Ingelheim Investigational Site
  • 1160.63.31003 Boehringer Ingelheim Investigational Site
  • 1160.63.31001 Boehringer Ingelheim Investigational Site
  • 1160.63.31009 Boehringer Ingelheim Investigational Site
  • 1160.63.31008 Boehringer Ingelheim Investigational Site
  • 1160.63.64002 Boehringer Ingelheim Investigational Site
  • 1160.63.48010 Boehringer Ingelheim Investigational Site
  • 1160.63.48003 Boehringer Ingelheim Investigational Site
  • 1160.63.48001 Boehringer Ingelheim Investigational Site
  • 1160.63.48002 Boehringer Ingelheim Investigational Site
  • 1160.63.48004 Boehringer Ingelheim Investigational Site
  • 1160.63.48005 Boehringer Ingelheim Investigational Site
  • 1160.63.48006 Boehringer Ingelheim Investigational Site
  • 1160.63.48007 Boehringer Ingelheim Investigational Site
  • 1160.63.48008 Boehringer Ingelheim Investigational Site
  • 1160.63.07007 Boehringer Ingelheim Investigational Site
  • 1160.63.07004 Boehringer Ingelheim Investigational Site
  • 1160.63.07014 Boehringer Ingelheim Investigational Site
  • 1160.63.07005 Boehringer Ingelheim Investigational Site
  • 1160.63.07006 Boehringer Ingelheim Investigational Site
  • 1160.63.65001 Boehringer Ingelheim Investigational Site
  • 1160.63.27003 Boehringer Ingelheim Investigational Site
  • 1160.63.27007 Boehringer Ingelheim Investigational Site
  • 1160.63.27009 Boehringer Ingelheim Investigational Site
  • 1160.63.27001 Boehringer Ingelheim Investigational Site
  • 1160.63.46001 Boehringer Ingelheim Investigational Site
  • 1160.63.46006 Boehringer Ingelheim Investigational Site
  • 1160.63.46002 Boehringer Ingelheim Investigational Site
  • 1160.63.46004 Boehringer Ingelheim Investigational Site
  • 1160.63.46007 Boehringer Ingelheim Investigational Site
  • 1160.63.46005 Boehringer Ingelheim Investigational Site
  • 1160.63.46003 Boehringer Ingelheim Investigational Site
  • 1160.63.41012 Boehringer Ingelheim Investigational Site
  • 1160.63.41011 Boehringer Ingelheim Investigational Site
  • 1160.63.41003 Boehringer Ingelheim Investigational Site
  • 1160.63.41001 Boehringer Ingelheim Investigational Site
  • 1160.63.41016 Boehringer Ingelheim Investigational Site
  • 1160.63.41014 Boehringer Ingelheim Investigational Site
  • 1160.63.41005 Boehringer Ingelheim Investigational Site
  • 1160.63.41009 Boehringer Ingelheim Investigational Site
  • 1160.63.41022 Boehringer Ingelheim Investigational Site
  • 1160.63.41008 Boehringer Ingelheim Investigational Site
  • 1160.63.41006 Boehringer Ingelheim Investigational Site
  • 1160.63.66002 Boehringer Ingelheim Investigational Site
  • 1160.63.66003 Boehringer Ingelheim Investigational Site
  • 1160.63.66004 Boehringer Ingelheim Investigational Site
  • 1160.63.66001 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

dabigatran etexilate 150 mg BID

matching placebo twice daily (BID)

Arm Description

Patient to receive dabigatran etexilatate capsules 150 mg twice daily

Patient to receive dabigatran extexilate matching placebo capsules twice daily

Outcomes

Primary Outcome Measures

Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period
Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.

Secondary Outcome Measures

Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period
Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.
Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period
Number of the participants with centrally confirmed symptomatic recurrent deep venous thrombotic (DVT) events during the intended treatment period were described.
Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period
Number of participants with centrally confirmed symptomatic pulmonary embolism (PE) events during the intended treatment period were described.
Centrally Confirmed Unexplained Deaths During the Intended Treatment Period
Number of participants with centrally confirmed unexplained deaths during the intended treatment period were described.
Centrally Confirmed Bleeding Event During the Treatment Period
Major bleeding events (MBE) had to fulfil at least 1 of the following criteria: Fatal bleeding Associated with a fall in haemoglobin of ≥2 g/dL Led to the transfusion of ≥2 units packed cells or whole blood Occurred in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal Other clinically relevant bleeding was defined as overt bleeding not meeting the criteria for an MBE but associated with medical intervention, unscheduled contact with a physician, (temporary) cessation of study treatment, or associated with discomfort such as pain, or impairment of activities of daily life. Examples of these bleedings were: Bleeding that compromised haemodynamics Bleeding that led to hospitalisation Trivial bleeding events were defined as all other bleeding events that did not fulfil the criteria of MBEs or CRBEs. All bleeding events include MBEs, CRBEs, and trivial bleeding events.
Centrally Confirmed Cardiovascular Events During the Treatment Period
Cardiovascular events that occurred during the treatment period + 3 days were summarised by treatment groups.
Laboratory Measures, Especially Liver Function Tests (LFTs)
Number of participants with possible clinically significant abnormalities during the treatment period.

Full Information

First Posted
November 13, 2007
Last Updated
June 17, 2014
Sponsor
Boehringer Ingelheim
search

1. Study Identification

Unique Protocol Identification Number
NCT00558259
Brief Title
Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE
Acronym
RE-SONATE
Official Title
Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long-term Prevention of Recurrent Symptomatic Proximal Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with vitamin K antagonist (VKA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1353 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dabigatran etexilate 150 mg BID
Arm Type
Experimental
Arm Description
Patient to receive dabigatran etexilatate capsules 150 mg twice daily
Arm Title
matching placebo twice daily (BID)
Arm Type
Placebo Comparator
Arm Description
Patient to receive dabigatran extexilate matching placebo capsules twice daily
Intervention Type
Drug
Intervention Name(s)
dabigatran etexilate 150 mg twice daily (BID)
Intervention Description
dabigatran etexilate capsules 150 mg BID
Intervention Type
Drug
Intervention Name(s)
matching placebo twice daily (BID)
Intervention Description
Matching placebo BID
Primary Outcome Measure Information:
Title
Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period
Description
Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period
Description
Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.
Time Frame
6 months
Title
Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period
Description
Number of the participants with centrally confirmed symptomatic recurrent deep venous thrombotic (DVT) events during the intended treatment period were described.
Time Frame
6 months
Title
Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period
Description
Number of participants with centrally confirmed symptomatic pulmonary embolism (PE) events during the intended treatment period were described.
Time Frame
6 months
Title
Centrally Confirmed Unexplained Deaths During the Intended Treatment Period
Description
Number of participants with centrally confirmed unexplained deaths during the intended treatment period were described.
Time Frame
6 months
Title
Centrally Confirmed Bleeding Event During the Treatment Period
Description
Major bleeding events (MBE) had to fulfil at least 1 of the following criteria: Fatal bleeding Associated with a fall in haemoglobin of ≥2 g/dL Led to the transfusion of ≥2 units packed cells or whole blood Occurred in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal Other clinically relevant bleeding was defined as overt bleeding not meeting the criteria for an MBE but associated with medical intervention, unscheduled contact with a physician, (temporary) cessation of study treatment, or associated with discomfort such as pain, or impairment of activities of daily life. Examples of these bleedings were: Bleeding that compromised haemodynamics Bleeding that led to hospitalisation Trivial bleeding events were defined as all other bleeding events that did not fulfil the criteria of MBEs or CRBEs. All bleeding events include MBEs, CRBEs, and trivial bleeding events.
Time Frame
6 months
Title
Centrally Confirmed Cardiovascular Events During the Treatment Period
Description
Cardiovascular events that occurred during the treatment period + 3 days were summarised by treatment groups.
Time Frame
6 months
Title
Laboratory Measures, Especially Liver Function Tests (LFTs)
Description
Number of participants with possible clinically significant abnormalities during the treatment period.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients with confirmed symptomatic PE or proximal DVT of the leg(s) who have been treated for 6 to 18 months with therapeutic dosages (intended INR between 2-3) of an oral VKA (e.g. warfarin, acenocoumarol, phenprocoumon, or fluindione) or RE-COVER study medication up to the moment of screening for the current study. Written informed consent Exclusion criteria: Younger then 18 years of age Indication for VKA other than DVT and/or PE Patients in whom anticoagulant treatment for their index PE or DVT should be continued Active liver disease or liver disease decreasing survival (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN Creatinine clearance < 30 ml/min Acute bacterial endocarditis Active bleeding or high risk for bleeding. Uncontrolled hypertension (investigators judgement) Intake of another experimental drug within the 30 days prior to randomization into the study Life expectancy <6 months Childbearing potential without proper contraceptive measures*, pregnancy or breast feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1160.63.01025 Boehringer Ingelheim Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
1160.63.01023 Boehringer Ingelheim Investigational Site
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
1160.63.01002 Boehringer Ingelheim Investigational Site
City
Laguna Hills
State/Province
California
Country
United States
Facility Name
1160.63.01014 Boehringer Ingelheim Investigational Site
City
Colorado Springs
State/Province
Colorado
Country
United States
Facility Name
1160.63.01003 Boehringer Ingelheim Investigational Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
1160.63.01030 Boehringer Ingelheim Investigational Site
City
Key West
State/Province
Florida
Country
United States
Facility Name
1160.63.01022 Boehringer Ingelheim Investigational Site
City
Lafayette
State/Province
Louisiana
Country
United States
Facility Name
1160.63.01044 Boehringer Ingelheim Investigational Site
City
New Iberia
State/Province
Louisiana
Country
United States
Facility Name
1160.63.01017 Boehringer Ingelheim Investigational Site
City
Biddeford
State/Province
Maine
Country
United States
Facility Name
1160.63.01004 Boehringer Ingelheim Investigational Site
City
Salisbury
State/Province
Maryland
Country
United States
Facility Name
1160.63.01016 Boehringer Ingelheim Investigational Site
City
Worcester
State/Province
Massachusetts
Country
United States
Facility Name
1160.63.01037 Boehringer Ingelheim Investigational Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
1160.63.01019 Boehringer Ingelheim Investigational Site
City
Missoula
State/Province
Montana
Country
United States
Facility Name
1160.63.01032 Boehringer Ingelheim Investigational Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
1160.63.01001 Boehringer Ingelheim Investigational Site
City
Uniontown
State/Province
Pennsylvania
Country
United States
Facility Name
1160.63.01024 Boehringer Ingelheim Investigational Site
City
Uniontown
State/Province
Pennsylvania
Country
United States
Facility Name
1160.63.01005 Boehringer Ingelheim Investigational Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
1160.63.01020 Boehringer Ingelheim Investigational Site
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
1160.63.01011 Boehringer Ingelheim Investigational Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
1160.63.01007 Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
1160.63.01035 Boehringer Ingelheim Investigational Site
City
Bellevue
State/Province
Washington
Country
United States
Facility Name
1160.63.61002 Boehringer Ingelheim Investigational Site
City
Greenslopes
State/Province
Queensland
Country
Australia
Facility Name
1160.63.61003 Boehringer Ingelheim Investigational Site
City
Elizabeth Vale
State/Province
South Australia
Country
Australia
Facility Name
1160.63.61001 Boehringer Ingelheim Investigational Site
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
1160.63.61004 Boehringer Ingelheim Investigational Site
City
Nedlands
State/Province
Western Australia
Country
Australia
Facility Name
1160.63.43005 Boehringer Ingelheim Investigational Site
City
Graz
Country
Austria
Facility Name
1160.63.43006 Boehringer Ingelheim Investigational Site
City
Innsbruck
Country
Austria
Facility Name
1160.63.43001 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1160.63.43002 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1160.63.43004 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1160.63.32005 Boehringer Ingelheim Investigational Site
City
Aalst
Country
Belgium
Facility Name
1160.63.32004 Boehringer Ingelheim Investigational Site
City
Duffel
Country
Belgium
Facility Name
1160.63.32003 Boehringer Ingelheim Investigational Site
City
Kortrijk
Country
Belgium
Facility Name
1160.63.32001 Boehringer Ingelheim Investigational Site
City
Leuven
Country
Belgium
Facility Name
1160.63.32002 Boehringer Ingelheim Investigational Site
City
Lier
Country
Belgium
Facility Name
1160.63.02013 Boehringer Ingelheim Investigational Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
1160.63.02004 Boehringer Ingelheim Investigational Site
City
Saint John
State/Province
New Brunswick
Country
Canada
Facility Name
1160.63.02005 Boehringer Ingelheim Investigational Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
1160.63.02020 Boehringer Ingelheim Investigational Site
City
Quebec
Country
Canada
Facility Name
1160.63.42004 Boehringer Ingelheim Investigational Site
City
Ceske Budejovice
Country
Czech Republic
Facility Name
1160.63.42003 Boehringer Ingelheim Investigational Site
City
Jablonec nad Nisou
Country
Czech Republic
Facility Name
1160.63.42008 Boehringer Ingelheim Investigational Site
City
Kladno
Country
Czech Republic
Facility Name
1160.63.42012 Boehringer Ingelheim Investigational Site
City
Liberec
Country
Czech Republic
Facility Name
1160.63.42010 Boehringer Ingelheim Investigational Site
City
Nymburk
Country
Czech Republic
Facility Name
1160.63.42011 Boehringer Ingelheim Investigational Site
City
Ostrava-Vitkovice
Country
Czech Republic
Facility Name
1160.63.42009 Boehringer Ingelheim Investigational Site
City
Ostrava
Country
Czech Republic
Facility Name
1160.63.42002 Boehringer Ingelheim Investigational Site
City
Prague 4-Krc
Country
Czech Republic
Facility Name
1160.63.42001 Boehringer Ingelheim Investigational Site
City
Prague 4
Country
Czech Republic
Facility Name
1160.63.42006 Boehringer Ingelheim Investigational Site
City
Praha 4
Country
Czech Republic
Facility Name
1160.63.42005 Boehringer Ingelheim Investigational Site
City
Prostejov
Country
Czech Republic
Facility Name
1160.63.42007 Boehringer Ingelheim Investigational Site
City
Rakovnik
Country
Czech Republic
Facility Name
1160.63.42013 Boehringer Ingelheim Investigational Site
City
Slany
Country
Czech Republic
Facility Name
1160.63.42014 Boehringer Ingelheim Investigational Site
City
Tabor
Country
Czech Republic
Facility Name
1160.63.37202 Boehringer Ingelheim Investigational Site
City
Kohtla-Järve
Country
Estonia
Facility Name
1160.63.37203 Boehringer Ingelheim Investigational Site
City
Tallin
Country
Estonia
Facility Name
1160.63.37201 Boehringer Ingelheim Investigational Site
City
Tartu
Country
Estonia
Facility Name
1160.63.49013 Boehringer Ingelheim Investigational Site
City
Darmstadt
Country
Germany
Facility Name
1160.63.49017 Boehringer Ingelheim Investigational Site
City
Dresden
Country
Germany
Facility Name
1160.63.49018 Boehringer Ingelheim Investigational Site
City
Dresden
Country
Germany
Facility Name
1160.63.49014 Boehringer Ingelheim Investigational Site
City
Gießen
Country
Germany
Facility Name
1160.63.49011 Boehringer Ingelheim Investigational Site
City
Ludwigshafen
Country
Germany
Facility Name
1160.63.49005 Boehringer Ingelheim Investigational Site
City
Mannheim
Country
Germany
Facility Name
1160.63.49010 Boehringer Ingelheim Investigational Site
City
Mannheim
Country
Germany
Facility Name
1160.63.49007 Boehringer Ingelheim Investigational Site
City
München
Country
Germany
Facility Name
1160.63.49009 Boehringer Ingelheim Investigational Site
City
Püttlingen
Country
Germany
Facility Name
1160.63.39006 Boehringer Ingelheim Investigational Site
City
Bergamo
Country
Italy
Facility Name
1160.63.39015 Boehringer Ingelheim Investigational Site
City
Castelfranco Veneto (TV)
Country
Italy
Facility Name
1160.63.39019 Boehringer Ingelheim Investigational Site
City
Chieti Scalo (CH)
Country
Italy
Facility Name
1160.63.39003 Boehringer Ingelheim Investigational Site
City
Cosenza
Country
Italy
Facility Name
1160.63.39008 Boehringer Ingelheim Investigational Site
City
Fidenza (PR)
Country
Italy
Facility Name
1160.63.39011 Boehringer Ingelheim Investigational Site
City
Firenze
Country
Italy
Facility Name
1160.63.39009 Boehringer Ingelheim Investigational Site
City
Genova
Country
Italy
Facility Name
1160.63.39004 Boehringer Ingelheim Investigational Site
City
Milano
Country
Italy
Facility Name
1160.63.39010 Boehringer Ingelheim Investigational Site
City
Milano
Country
Italy
Facility Name
1160.63.39020 Boehringer Ingelheim Investigational Site
City
Milano
Country
Italy
Facility Name
1160.63.39022 Boehringer Ingelheim Investigational Site
City
Napoli
Country
Italy
Facility Name
1160.63.39001 Boehringer Ingelheim Investigational Site
City
Palermo
Country
Italy
Facility Name
1160.63.39007 Boehringer Ingelheim Investigational Site
City
Pisa
Country
Italy
Facility Name
1160.63.39012 Boehringer Ingelheim Investigational Site
City
Rimini
Country
Italy
Facility Name
1160.63.39017 Boehringer Ingelheim Investigational Site
City
Roma
Country
Italy
Facility Name
1160.63.39014 Boehringer Ingelheim Investigational Site
City
Treviso
Country
Italy
Facility Name
1160.63.39002 Boehringer Ingelheim Investigational Site
City
Udine
Country
Italy
Facility Name
1160.63.39016 Boehringer Ingelheim Investigational Site
City
Vittorio veneto (TV)
Country
Italy
Facility Name
1160.63.82010 Boehringer Ingelheim Investigational Site
City
Gwangju-si
Country
Korea, Republic of
Facility Name
1160.63.82003 Boehringer Ingelheim Investigational Site
City
Incheon
Country
Korea, Republic of
Facility Name
1160.63.82005 Boehringer Ingelheim Investigational Site
City
Kyeonggi-do
Country
Korea, Republic of
Facility Name
1160.63.82001 Boehringer Ingelheim Investigational Site
City
Kyunggi-do
Country
Korea, Republic of
Facility Name
1160.63.82004 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1160.63.82006 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1160.63.82008 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1160.63.82011 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1160.63.82007 Boehringer Ingelheim Investigational Site
City
Suwon
Country
Korea, Republic of
Facility Name
1160.63.37101 Boehringer Ingelheim Investigational Site
City
Daugavpils
Country
Latvia
Facility Name
1160.63.37102 Boehringer Ingelheim Investigational Site
City
Riga
Country
Latvia
Facility Name
1160.63.37002 Boehringer Ingelheim Investigational Site
City
Kaunas
Country
Lithuania
Facility Name
1160.63.37001 Boehringer Ingelheim Investigational Site
City
Vilnius
Country
Lithuania
Facility Name
1160.63.31010 Boehringer Ingelheim Investigational Site
City
Assen
Country
Netherlands
Facility Name
1160.63.31006 Boehringer Ingelheim Investigational Site
City
Breda
Country
Netherlands
Facility Name
1160.63.31007 Boehringer Ingelheim Investigational Site
City
Den Haag
Country
Netherlands
Facility Name
1160.63.31011 Boehringer Ingelheim Investigational Site
City
Den Helder
Country
Netherlands
Facility Name
1160.63.31012 Boehringer Ingelheim Investigational Site
City
Dirksland
Country
Netherlands
Facility Name
1160.63.31003 Boehringer Ingelheim Investigational Site
City
Eindhoven
Country
Netherlands
Facility Name
1160.63.31001 Boehringer Ingelheim Investigational Site
City
Groningen
Country
Netherlands
Facility Name
1160.63.31009 Boehringer Ingelheim Investigational Site
City
Heerlen
Country
Netherlands
Facility Name
1160.63.31008 Boehringer Ingelheim Investigational Site
City
Oss
Country
Netherlands
Facility Name
1160.63.64002 Boehringer Ingelheim Investigational Site
City
Christchurch
Country
New Zealand
Facility Name
1160.63.48010 Boehringer Ingelheim Investigational Site
City
Kielce
Country
Poland
Facility Name
1160.63.48003 Boehringer Ingelheim Investigational Site
City
Poznan
Country
Poland
Facility Name
1160.63.48001 Boehringer Ingelheim Investigational Site
City
Warsaw
Country
Poland
Facility Name
1160.63.48002 Boehringer Ingelheim Investigational Site
City
Warsaw
Country
Poland
Facility Name
1160.63.48004 Boehringer Ingelheim Investigational Site
City
Warsaw
Country
Poland
Facility Name
1160.63.48005 Boehringer Ingelheim Investigational Site
City
Warsaw
Country
Poland
Facility Name
1160.63.48006 Boehringer Ingelheim Investigational Site
City
Warsaw
Country
Poland
Facility Name
1160.63.48007 Boehringer Ingelheim Investigational Site
City
Warsaw
Country
Poland
Facility Name
1160.63.48008 Boehringer Ingelheim Investigational Site
City
Warsaw
Country
Poland
Facility Name
1160.63.07007 Boehringer Ingelheim Investigational Site
City
Ekaterinburg
Country
Russian Federation
Facility Name
1160.63.07004 Boehringer Ingelheim Investigational Site
City
Kursk
Country
Russian Federation
Facility Name
1160.63.07014 Boehringer Ingelheim Investigational Site
City
Ufa
Country
Russian Federation
Facility Name
1160.63.07005 Boehringer Ingelheim Investigational Site
City
Yaroslavl
Country
Russian Federation
Facility Name
1160.63.07006 Boehringer Ingelheim Investigational Site
City
Yaroslavl
Country
Russian Federation
Facility Name
1160.63.65001 Boehringer Ingelheim Investigational Site
City
Singapore
Country
Singapore
Facility Name
1160.63.27003 Boehringer Ingelheim Investigational Site
City
Cape Town
Country
South Africa
Facility Name
1160.63.27007 Boehringer Ingelheim Investigational Site
City
Centurion
Country
South Africa
Facility Name
1160.63.27009 Boehringer Ingelheim Investigational Site
City
Krugersdorp
Country
South Africa
Facility Name
1160.63.27001 Boehringer Ingelheim Investigational Site
City
Somerset West
Country
South Africa
Facility Name
1160.63.46001 Boehringer Ingelheim Investigational Site
City
Göteborg
Country
Sweden
Facility Name
1160.63.46006 Boehringer Ingelheim Investigational Site
City
Göteborg
Country
Sweden
Facility Name
1160.63.46002 Boehringer Ingelheim Investigational Site
City
Lund
Country
Sweden
Facility Name
1160.63.46004 Boehringer Ingelheim Investigational Site
City
Mölndal
Country
Sweden
Facility Name
1160.63.46007 Boehringer Ingelheim Investigational Site
City
Skövde
Country
Sweden
Facility Name
1160.63.46005 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
1160.63.46003 Boehringer Ingelheim Investigational Site
City
Värnamo
Country
Sweden
Facility Name
1160.63.41012 Boehringer Ingelheim Investigational Site
City
Basel
Country
Switzerland
Facility Name
1160.63.41011 Boehringer Ingelheim Investigational Site
City
Bruderholz
Country
Switzerland
Facility Name
1160.63.41003 Boehringer Ingelheim Investigational Site
City
Cham
Country
Switzerland
Facility Name
1160.63.41001 Boehringer Ingelheim Investigational Site
City
Glarus
Country
Switzerland
Facility Name
1160.63.41016 Boehringer Ingelheim Investigational Site
City
Luzern 16
Country
Switzerland
Facility Name
1160.63.41014 Boehringer Ingelheim Investigational Site
City
Luzern
Country
Switzerland
Facility Name
1160.63.41005 Boehringer Ingelheim Investigational Site
City
Schiers
Country
Switzerland
Facility Name
1160.63.41009 Boehringer Ingelheim Investigational Site
City
Thun
Country
Switzerland
Facility Name
1160.63.41022 Boehringer Ingelheim Investigational Site
City
Wetzikon
Country
Switzerland
Facility Name
1160.63.41008 Boehringer Ingelheim Investigational Site
City
Zug
Country
Switzerland
Facility Name
1160.63.41006 Boehringer Ingelheim Investigational Site
City
Zurich
Country
Switzerland
Facility Name
1160.63.66002 Boehringer Ingelheim Investigational Site
City
Bangkok
Country
Thailand
Facility Name
1160.63.66003 Boehringer Ingelheim Investigational Site
City
Bangkok
Country
Thailand
Facility Name
1160.63.66004 Boehringer Ingelheim Investigational Site
City
Bangkok
Country
Thailand
Facility Name
1160.63.66001 Boehringer Ingelheim Investigational Site
City
Chiang Mai
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
24081972
Citation
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.
Results Reference
derived
PubMed Identifier
23425163
Citation
Schulman S, Kearon C, Kakkar AK, Schellong S, Eriksson H, Baanstra D, Kvamme AM, Friedman J, Mismetti P, Goldhaber SZ; RE-MEDY Trial Investigators; RE-SONATE Trial Investigators. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):709-18. doi: 10.1056/NEJMoa1113697.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.63_U11-2267-02-DS.pdf
Description
Related Info

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Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE

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