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Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE) (RE-COVER II)

Primary Purpose

Thromboembolism

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Warfarin
Dabigatran etexilate
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thromboembolism

Eligibility Criteria

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

Inclusion criteria:

  • Acute symptomatic uni- or bilateral Deep Vein Thrombosis (DVT) of the leg involving proximal veins, and/or Pulmonary Embolism (PE)
  • Male or female, being 18 years of age or older
  • Written informed consent for study participation

Exclusion criteria:

  • Persistent symptoms of VTE
  • PE requiring urgent intervention
  • Use of vena cava filter
  • Contraindications to anticoagulant therapy
  • Allergy to study medications
  • Elevated Aspartate-aminotransferase (AST) or Alanine-aminotransferase (ALT) > 3x Upper Limit of Normal (ULN) or known liver disease expected to have an impact on survival
  • Severe renal impairment
  • Patients considered unsuitable for inclusion

Sites / Locations

  • 1160.46.01073 Boehringer Ingelheim Investigational Site
  • 1160.46.01044 Boehringer Ingelheim Investigational Site
  • 1160.46.01068 Boehringer Ingelheim Investigational Site
  • 1160.46.01071 Boehringer Ingelheim Investigational Site
  • 1160.46.01060 Boehringer Ingelheim Investigational Site
  • 1160.46.01061 Boehringer Ingelheim Investigational Site
  • 1160.46.01059 Boehringer Ingelheim Investigational Site
  • 1160.46.01063 Boehringer Ingelheim Investigational Site
  • 1160.46.01055 Boehringer Ingelheim Investigational Site
  • 1160.46.01062 Boehringer Ingelheim Investigational Site
  • 1160.46.61007 Boehringer Ingelheim Investigational Site
  • 1160.46.61003 Boehringer Ingelheim Investigational Site
  • 1160.46.61001 Boehringer Ingelheim Investigational Site
  • 1160.46.61006 Boehringer Ingelheim Investigational Site
  • 1160.46.61005 Boehringer Ingelheim Investigational Site
  • 1160.46.55010 Boehringer Ingelheim Investigational Site
  • 1160.46.55007 Boehringer Ingelheim Investigational Site
  • 1160.46.55014 Boehringer Ingelheim Investigational Site
  • 1160.46.55017 Boehringer Ingelheim Investigational Site
  • 1160.46.55019 Boehringer Ingelheim Investigational Site
  • 1160.46.55021 Boehringer Ingelheim Investigational Site
  • 1160.46.55016 Boehringer Ingelheim Investigational Site
  • 1160.46.55018 Boehringer Ingelheim Investigational Site
  • 1160.46.55020 Boehringer Ingelheim Investigational Site
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  • 1160.46.02006 Boehringer Ingelheim Investigational Site
  • 1160.46.02013 Boehringer Ingelheim Investigational Site
  • 1160.46.02021 Boehringer Ingelheim Investigational Site
  • 1160.46.02004 Boehringer Ingelheim Investigational Site
  • 1160.46.02001 Boehringer Ingelheim Investigational Site
  • 1160.46.02002 Boehringer Ingelheim Investigational Site
  • 1160.46.02005 Boehringer Ingelheim Investigational Site
  • 1160.46.02010 Boehringer Ingelheim Investigational Site
  • 1160.46.02015 Boehringer Ingelheim Investigational Site
  • 1160.46.02019 Boehringer Ingelheim Investigational Site
  • 1160.46.02008 Boehringer Ingelheim Investigational Site
  • 1160.46.02009 Boehringer Ingelheim Investigational Site
  • 1160.46.02014 Boehringer Ingelheim Investigational Site
  • 1160.46.02017 Boehringer Ingelheim Investigational Site
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  • 1160.46.42001 Boehringer Ingelheim Investigational Site
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  • 1160.46.42012 Boehringer Ingelheim Investigational Site
  • 1160.46.42018 Boehringer Ingelheim Investigational Site
  • 1160.46.42015 Boehringer Ingelheim Investigational Site
  • 1160.46.42005 Boehringer Ingelheim Investigational Site
  • 1160.46.42017 Boehringer Ingelheim Investigational Site
  • 1160.46.42014 Boehringer Ingelheim Investigational Site
  • 1160.46.42016 Boehringer Ingelheim Investigational Site
  • 1160.46.42010 Boehringer Ingelheim Investigational Site
  • 1160.46.42007 Boehringer Ingelheim Investigational Site
  • 1160.46.45001 Boehringer Ingelheim Investigational Site
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  • 1160.46.3301A Boehringer Ingelheim Investigational Site
  • 1160.46.3301B Boehringer Ingelheim Investigational Site
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  • 1160.46.3315B Boehringer Ingelheim Investigational Site
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  • 1160.46.36002 Boehringer Ingelheim Investigational Site
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  • 1160.46.91006 Boehringer Ingelheim Investigational Site
  • 1160.46.91010 Boehringer Ingelheim Investigational Site
  • 1160.46.91002 Boehringer Ingelheim Investigational Site
  • 1160.46.91007 Boehringer Ingelheim Investigational Site
  • 1160.46.91012 Boehringer Ingelheim Investigational Site
  • 1160.46.91009 Boehringer Ingelheim Investigational Site
  • 1160.46.91008 Boehringer Ingelheim Investigational Site
  • 1160.46.91005 Boehringer Ingelheim Investigational Site
  • 1160.46.91014 Boehringer Ingelheim Investigational Site
  • 1160.46.91001 Boehringer Ingelheim Investigational Site
  • 1160.46.91004 Boehringer Ingelheim Investigational Site
  • 1160.46.91011 Boehringer Ingelheim Investigational Site
  • 1160.46.91013 Boehringer Ingelheim Investigational Site
  • 1160.46.91003 Boehringer Ingelheim Investigational Site
  • 1160.46.97202 Boehringer Ingelheim Investigational Site
  • 1160.46.97207 Boehringer Ingelheim Investigational Site
  • 1160.46.97212 Boehringer Ingelheim Investigational Site
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  • 1160.46.97203 Boehringer Ingelheim Investigational Site
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  • 1160.46.97206 Boehringer Ingelheim Investigational Site
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  • 1160.46.97204 Boehringer Ingelheim Investigational Site
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  • 1160.46.82008 Boehringer Ingelheim Investigational Site
  • 1160.46.82010 Boehringer Ingelheim Investigational Site
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  • 1160.46.82005 Boehringer Ingelheim Investigational Site
  • 1160.46.82006 Boehringer Ingelheim Investigational Site
  • 1160.46.82009 Boehringer Ingelheim Investigational Site
  • 1160.46.60001 Boehringer Ingelheim Investigational Site
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  • 1160.46.31017 Boehringer Ingelheim Investigational Site
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  • 1160.46.31002 Boehringer Ingelheim Investigational Site
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  • 1160.46.64004 Boehringer Ingelheim Investigational Site
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  • 1160.46.64002 Boehringer Ingelheim Investigational Site
  • 1160.46.64001 Boehringer Ingelheim Investigational Site
  • 1160.46.47001 Boehringer Ingelheim Investigational Site
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  • 1160.46.48004 Boehringer Ingelheim Investigational Site
  • 1160.46.48001 Boehringer Ingelheim Investigational Site
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  • 1160.46.48003 Boehringer Ingelheim Investigational Site
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  • 1160.46.07021 Boehringer Ingelheim Investigational Site
  • 1160.46.07007 Boehringer Ingelheim Investigational Site
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  • 1160.46.07024 Boehringer Ingelheim Investigational Site
  • 1160.46.07014 Boehringer Ingelheim Investigational Site
  • 1160.46.07005 Boehringer Ingelheim Investigational Site
  • 1160.46.07006 Boehringer Ingelheim Investigational Site
  • 1160.46.65001 Boehringer Ingelheim Investigational Site
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  • 1160.46.42107 Boehringer Ingelheim Investigational Site
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  • 1160.46.34002 Boehringer Ingelheim Investigational Site
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  • 1160.46.46002 Boehringer Ingelheim Investigational Site
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  • 1160.46.46001 Boehringer Ingelheim Investigational Site
  • 1160.46.46008 Boehringer Ingelheim Investigational Site
  • 1160.46.46003 Boehringer Ingelheim Investigational Site
  • 1160.46.88607 Boehringer Ingelheim Investigational Site
  • 1160.46.88604 Boehringer Ingelheim Investigational Site
  • 1160.46.88606 Boehringer Ingelheim Investigational Site
  • 1160.46.88608 Boehringer Ingelheim Investigational Site
  • 1160.46.88609 Boehringer Ingelheim Investigational Site
  • 1160.46.66007 Boehringer Ingelheim Investigational Site
  • 1160.46.66010 Boehringer Ingelheim Investigational Site
  • 1160.46.66001 Boehringer Ingelheim Investigational Site
  • 1160.46.66004 Boehringer Ingelheim Investigational Site
  • 1160.46.66005 Boehringer Ingelheim Investigational Site
  • 1160.46.66006 Boehringer Ingelheim Investigational Site
  • 1160.46.66008 Boehringer Ingelheim Investigational Site
  • 1160.46.90003 Boehringer Ingelheim Investigational Site
  • 1160.46.90004 Boehringer Ingelheim Investigational Site
  • 1160.46.90001 Boehringer Ingelheim Investigational Site
  • 1160.46.90002 Boehringer Ingelheim Investigational Site
  • 1160.46.90007 Boehringer Ingelheim Investigational Site
  • 1160.46.90008 Boehringer Ingelheim Investigational Site
  • 1160.46.90009 Boehringer Ingelheim Investigational Site
  • 1160.46.90010 Boehringer Ingelheim Investigational Site
  • 1160.46.38005 Boehringer Ingelheim Investigational Site
  • 1160.46.44005 Boehringer Ingelheim Investigational Site
  • 1160.46.44011 Boehringer Ingelheim Investigational Site
  • 1160.46.44006 Boehringer Ingelheim Investigational Site
  • 1160.46.44013 Boehringer Ingelheim Investigational Site
  • 1160.46.44012 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dabigatran etexilate (150mg bid)

Warfarin (INR 2.0-3.0)

Arm Description

Patients will receive 1 capsule containing 150 mg dabigatran etexilate/matching placebo twice daily

Patients will receive tablets PRN warfarin/matching placebo to maintain a target INR of 2.0-3.0

Outcomes

Primary Outcome Measures

Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.

Secondary Outcome Measures

Number of Participants With Recurrent Symptomatic VTE and All Deaths
VTE or any death which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Number of Participants With Recurrent Symptomatic DVT
Symptomatic DVT which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Number of Participants With Recurrent Symptomatic Non-fatal PE
Symptomatic non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Number of Participants Who Died Due to VTE
VTE - related deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. Hazard ratios and 95% CI were not calculated because of insufficient number of events.
Number of Participants Who Died (Any Cause)
Any deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE
Symptomatic fatal and non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events
Major bleeding events (MBE) are defined as 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 Clinically-relevant bleeding events (CRBE) are defined as spontaneous skin hematoma >=25 cm² wound hematoma >=100 cm² spontaneous nose bleed >5 min macroscopic hematuria spontaneous or >24 hours if associated with an intervention spontaneous rectal bleeding gingival bleeding >5 min leading to hospitalisation and / or requiring surgical treatment leading to a transfusion of <2 units of whole blood or red cells any other bleeding event considered clinically relevant by the investigator Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.
Number of Participants With Acute Coronary Syndrome (ACS)
Any ACS occurring during the conduct of the study (centrally adjudicated as definite). Patients having a centrally adjudicated definite ACS during intake of study drug and after stopping study drug, according to treatment group. ACS assessments pre-specified in the protocol without adjudication. Prior to database lock, the steering committee asked to have ACS events adjudicated by an independent committee. After database lock, the committee was provided with source documentation that was blinded to the patient's treatment assignment. ACS results presented are based on adjudication findings.
Laboratory Analyses
Frequency of patients with possible clinically significant abnormalities.

Full Information

First Posted
May 16, 2008
Last Updated
May 8, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00680186
Brief Title
Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)
Acronym
RE-COVER II
Official Title
A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism, Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 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 general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic VTE. The primary objective is to investigate the efficacy of dabigatran compared to warfarin during the 6 month treatment period. The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
2589 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dabigatran etexilate (150mg bid)
Arm Type
Experimental
Arm Description
Patients will receive 1 capsule containing 150 mg dabigatran etexilate/matching placebo twice daily
Arm Title
Warfarin (INR 2.0-3.0)
Arm Type
Active Comparator
Arm Description
Patients will receive tablets PRN warfarin/matching placebo to maintain a target INR of 2.0-3.0
Intervention Type
Drug
Intervention Name(s)
Warfarin
Intervention Description
PRN (to maintain a target INR of 2.0-3.0)
Intervention Type
Drug
Intervention Name(s)
Dabigatran etexilate
Intervention Description
150mg bid
Primary Outcome Measure Information:
Title
Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE
Description
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Time Frame
For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180)
Secondary Outcome Measure Information:
Title
Number of Participants With Recurrent Symptomatic VTE and All Deaths
Description
VTE or any death which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Time Frame
For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Title
Number of Participants With Recurrent Symptomatic DVT
Description
Symptomatic DVT which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Time Frame
For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Title
Number of Participants With Recurrent Symptomatic Non-fatal PE
Description
Symptomatic non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Time Frame
For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Title
Number of Participants Who Died Due to VTE
Description
VTE - related deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. Hazard ratios and 95% CI were not calculated because of insufficient number of events.
Time Frame
From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224)
Title
Number of Participants Who Died (Any Cause)
Description
Any deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Time Frame
For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Title
Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE
Description
Symptomatic fatal and non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Time Frame
For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Title
Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events
Description
Major bleeding events (MBE) are defined as 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 Clinically-relevant bleeding events (CRBE) are defined as spontaneous skin hematoma >=25 cm² wound hematoma >=100 cm² spontaneous nose bleed >5 min macroscopic hematuria spontaneous or >24 hours if associated with an intervention spontaneous rectal bleeding gingival bleeding >5 min leading to hospitalisation and / or requiring surgical treatment leading to a transfusion of <2 units of whole blood or red cells any other bleeding event considered clinically relevant by the investigator Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.
Time Frame
From first intake of study drug to last intake of study drug + 6 days washout
Title
Number of Participants With Acute Coronary Syndrome (ACS)
Description
Any ACS occurring during the conduct of the study (centrally adjudicated as definite). Patients having a centrally adjudicated definite ACS during intake of study drug and after stopping study drug, according to treatment group. ACS assessments pre-specified in the protocol without adjudication. Prior to database lock, the steering committee asked to have ACS events adjudicated by an independent committee. After database lock, the committee was provided with source documentation that was blinded to the patient's treatment assignment. ACS results presented are based on adjudication findings.
Time Frame
From first intake of study drug to last contact date
Title
Laboratory Analyses
Description
Frequency of patients with possible clinically significant abnormalities.
Time Frame
From first intake of study drug to last intake of study drug + 6 days washout

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Acute symptomatic uni- or bilateral Deep Vein Thrombosis (DVT) of the leg involving proximal veins, and/or Pulmonary Embolism (PE) Male or female, being 18 years of age or older Written informed consent for study participation Exclusion criteria: Persistent symptoms of VTE PE requiring urgent intervention Use of vena cava filter Contraindications to anticoagulant therapy Allergy to study medications Elevated Aspartate-aminotransferase (AST) or Alanine-aminotransferase (ALT) > 3x Upper Limit of Normal (ULN) or known liver disease expected to have an impact on survival Severe renal impairment Patients considered unsuitable for inclusion
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
1160.46.01073 Boehringer Ingelheim Investigational Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
1160.46.01044 Boehringer Ingelheim Investigational Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
1160.46.01068 Boehringer Ingelheim Investigational Site
City
Normal
State/Province
Illinois
Country
United States
Facility Name
1160.46.01071 Boehringer Ingelheim Investigational Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
1160.46.01060 Boehringer Ingelheim Investigational Site
City
Stony Brook
State/Province
New York
Country
United States
Facility Name
1160.46.01061 Boehringer Ingelheim Investigational Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
1160.46.01059 Boehringer Ingelheim Investigational Site
City
Bend
State/Province
Oregon
Country
United States
Facility Name
1160.46.01063 Boehringer Ingelheim Investigational Site
City
Corvallis
State/Province
Oregon
Country
United States
Facility Name
1160.46.01055 Boehringer Ingelheim Investigational Site
City
Summerville
State/Province
South Carolina
Country
United States
Facility Name
1160.46.01062 Boehringer Ingelheim Investigational Site
City
Bellevue
State/Province
Washington
Country
United States
Facility Name
1160.46.61007 Boehringer Ingelheim Investigational Site
City
Concord
State/Province
New South Wales
Country
Australia
Facility Name
1160.46.61003 Boehringer Ingelheim Investigational Site
City
Box Hill
State/Province
Victoria
Country
Australia
Facility Name
1160.46.61001 Boehringer Ingelheim Investigational Site
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
1160.46.61006 Boehringer Ingelheim Investigational Site
City
Windsor
State/Province
Victoria
Country
Australia
Facility Name
1160.46.61005 Boehringer Ingelheim Investigational Site
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
1160.46.55010 Boehringer Ingelheim Investigational Site
City
Brasília
Country
Brazil
Facility Name
1160.46.55007 Boehringer Ingelheim Investigational Site
City
Campinas
Country
Brazil
Facility Name
1160.46.55014 Boehringer Ingelheim Investigational Site
City
Curitiba
Country
Brazil
Facility Name
1160.46.55017 Boehringer Ingelheim Investigational Site
City
Curitiba
Country
Brazil
Facility Name
1160.46.55019 Boehringer Ingelheim Investigational Site
City
Porto Alegre
Country
Brazil
Facility Name
1160.46.55021 Boehringer Ingelheim Investigational Site
City
Recife
Country
Brazil
Facility Name
1160.46.55016 Boehringer Ingelheim Investigational Site
City
Rio de Janeiro - RJ
Country
Brazil
Facility Name
1160.46.55018 Boehringer Ingelheim Investigational Site
City
São Bernardo do Campo
Country
Brazil
Facility Name
1160.46.55020 Boehringer Ingelheim Investigational Site
City
São Paulo
Country
Brazil
Facility Name
1160.46.35901 Boehringer Ingelheim Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
1160.46.35903 Boehringer Ingelheim Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
1160.46.35906 Boehringer Ingelheim Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
1160.46.35905 Boehringer Ingelheim Investigational Site
City
Varna
Country
Bulgaria
Facility Name
1160.46.02006 Boehringer Ingelheim Investigational Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
1160.46.02013 Boehringer Ingelheim Investigational Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
1160.46.02021 Boehringer Ingelheim Investigational Site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
1160.46.02004 Boehringer Ingelheim Investigational Site
City
Saint John
State/Province
New Brunswick
Country
Canada
Facility Name
1160.46.02001 Boehringer Ingelheim Investigational Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
1160.46.02002 Boehringer Ingelheim Investigational Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
1160.46.02005 Boehringer Ingelheim Investigational Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
1160.46.02010 Boehringer Ingelheim Investigational Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
1160.46.02015 Boehringer Ingelheim Investigational Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
1160.46.02019 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1160.46.02008 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1160.46.02009 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1160.46.02014 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1160.46.02017 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1160.46.02020 Boehringer Ingelheim Investigational Site
City
Quebec
Country
Canada
Facility Name
1160.46.86001 Boehringer Ingelheim Investigational Site
City
Beijing
Country
China
Facility Name
1160.46.86002 Boehringer Ingelheim Investigational Site
City
Beijing
Country
China
Facility Name
1160.46.86019 Boehringer Ingelheim Investigational Site
City
Beijing
Country
China
Facility Name
1160.46.86014 Boehringer Ingelheim Investigational Site
City
Guangzhou
Country
China
Facility Name
1160.46.86015 Boehringer Ingelheim Investigational Site
City
Guangzhou
Country
China
Facility Name
1160.46.86016 Boehringer Ingelheim Investigational Site
City
Hangzhou
Country
China
Facility Name
1160.46.86003 Boehringer Ingelheim Investigational Site
City
Shanghai
Country
China
Facility Name
1160.46.86004 Boehringer Ingelheim Investigational Site
City
Shanghai
Country
China
Facility Name
1160.46.86005 Boehringer Ingelheim Investigational Site
City
Shanghai
Country
China
Facility Name
1160.46.86011 Boehringer Ingelheim Investigational Site
City
Shanghai
Country
China
Facility Name
1160.46.86007 Boehringer Ingelheim Investigational Site
City
Shenyang
Country
China
Facility Name
1160.46.86017 Boehringer Ingelheim Investigational Site
City
Shijiazhuang
Country
China
Facility Name
1160.46.86018 Boehringer Ingelheim Investigational Site
City
Shijiazhuang
Country
China
Facility Name
1160.46.86021 Boehringer Ingelheim Investigational Site
City
Taiyuan
Country
China
Facility Name
1160.46.86006 Boehringer Ingelheim Investigational Site
City
Tianjin
Country
China
Facility Name
1160.46.86020 Boehringer Ingelheim Investigational Site
City
Yinchuan
Country
China
Facility Name
1160.46.42001 Boehringer Ingelheim Investigational Site
City
Brno
Country
Czech Republic
Facility Name
1160.46.42002 Boehringer Ingelheim Investigational Site
City
Hradec Kralove
Country
Czech Republic
Facility Name
1160.46.42012 Boehringer Ingelheim Investigational Site
City
Liberec
Country
Czech Republic
Facility Name
1160.46.42018 Boehringer Ingelheim Investigational Site
City
Litomerice
Country
Czech Republic
Facility Name
1160.46.42015 Boehringer Ingelheim Investigational Site
City
Novy Jicin
Country
Czech Republic
Facility Name
1160.46.42005 Boehringer Ingelheim Investigational Site
City
Ostrava-Vitkovice
Country
Czech Republic
Facility Name
1160.46.42017 Boehringer Ingelheim Investigational Site
City
Prague 4
Country
Czech Republic
Facility Name
1160.46.42014 Boehringer Ingelheim Investigational Site
City
Tabor
Country
Czech Republic
Facility Name
1160.46.42016 Boehringer Ingelheim Investigational Site
City
Teplice
Country
Czech Republic
Facility Name
1160.46.42010 Boehringer Ingelheim Investigational Site
City
Usti nad Labem
Country
Czech Republic
Facility Name
1160.46.42007 Boehringer Ingelheim Investigational Site
City
Zlin
Country
Czech Republic
Facility Name
1160.46.45001 Boehringer Ingelheim Investigational Site
City
Aarhus C
Country
Denmark
Facility Name
1160.46.45008 Boehringer Ingelheim Investigational Site
City
Esbjerg
Country
Denmark
Facility Name
1160.46.45009 Boehringer Ingelheim Investigational Site
City
Holbæk
Country
Denmark
Facility Name
1160.46.45004 Boehringer Ingelheim Investigational Site
City
København NV
Country
Denmark
Facility Name
1160.46.3301A Boehringer Ingelheim Investigational Site
City
Brest Cedex
Country
France
Facility Name
1160.46.3301B Boehringer Ingelheim Investigational Site
City
Brest Cedex
Country
France
Facility Name
1160.46.3315A Boehringer Ingelheim Investigational Site
City
La Roche-Sur-Yon cedex 09
Country
France
Facility Name
1160.46.3315B Boehringer Ingelheim Investigational Site
City
La Roche-Sur-Yon cedex 09
Country
France
Facility Name
1160.46.3313A Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1160.46.3316A Boehringer Ingelheim Investigational Site
City
Pessac
Country
France
Facility Name
1160.46.3316B Boehringer Ingelheim Investigational Site
City
Pessac
Country
France
Facility Name
1160.46.3303C Boehringer Ingelheim Investigational Site
City
St Etienne Cedex 2
Country
France
Facility Name
1160.46.3303D Boehringer Ingelheim Investigational Site
City
St Etienne Cedex 2
Country
France
Facility Name
1160.46.3303E Boehringer Ingelheim Investigational Site
City
St Etienne Cedex 2
Country
France
Facility Name
1160.46.3303F Boehringer Ingelheim Investigational Site
City
St Etienne Cedex 2
Country
France
Facility Name
1160.46.3303G Boehringer Ingelheim Investigational Site
City
St Etienne Cedex 2
Country
France
Facility Name
1160.46.3303H Boehringer Ingelheim Investigational Site
City
St Etienne Cedex 2
Country
France
Facility Name
1160.46.3303A Boehringer Ingelheim Investigational Site
City
St Priest En Jarez Cedex
Country
France
Facility Name
1160.46.3303B Boehringer Ingelheim Investigational Site
City
St Priest En Jarez Cedex
Country
France
Facility Name
1160.46.36002 Boehringer Ingelheim Investigational Site
City
Debrecen
Country
Hungary
Facility Name
1160.46.36010 Boehringer Ingelheim Investigational Site
City
Szekesfehervar
Country
Hungary
Facility Name
1160.46.36011 Boehringer Ingelheim Investigational Site
City
Szombathely
Country
Hungary
Facility Name
1160.46.91006 Boehringer Ingelheim Investigational Site
City
Bangalore
Country
India
Facility Name
1160.46.91010 Boehringer Ingelheim Investigational Site
City
Bangalore
Country
India
Facility Name
1160.46.91002 Boehringer Ingelheim Investigational Site
City
Chennai
Country
India
Facility Name
1160.46.91007 Boehringer Ingelheim Investigational Site
City
Chennai
Country
India
Facility Name
1160.46.91012 Boehringer Ingelheim Investigational Site
City
Kolkata
Country
India
Facility Name
1160.46.91009 Boehringer Ingelheim Investigational Site
City
Ludhiana
Country
India
Facility Name
1160.46.91008 Boehringer Ingelheim Investigational Site
City
Nagpur
Country
India
Facility Name
1160.46.91005 Boehringer Ingelheim Investigational Site
City
New Delhi
Country
India
Facility Name
1160.46.91014 Boehringer Ingelheim Investigational Site
City
New Delhi
Country
India
Facility Name
1160.46.91001 Boehringer Ingelheim Investigational Site
City
Pune
Country
India
Facility Name
1160.46.91004 Boehringer Ingelheim Investigational Site
City
Pune
Country
India
Facility Name
1160.46.91011 Boehringer Ingelheim Investigational Site
City
Tamil Nadu
Country
India
Facility Name
1160.46.91013 Boehringer Ingelheim Investigational Site
City
Vadodara
Country
India
Facility Name
1160.46.91003 Boehringer Ingelheim Investigational Site
City
Vadodra
Country
India
Facility Name
1160.46.97202 Boehringer Ingelheim Investigational Site
City
Afula
Country
Israel
Facility Name
1160.46.97207 Boehringer Ingelheim Investigational Site
City
Ashkelon
Country
Israel
Facility Name
1160.46.97212 Boehringer Ingelheim Investigational Site
City
DN Lower Galillee
Country
Israel
Facility Name
1160.46.97211 Boehringer Ingelheim Investigational Site
City
Haifa
Country
Israel
Facility Name
1160.46.97203 Boehringer Ingelheim Investigational Site
City
Holon
Country
Israel
Facility Name
1160.46.97205 Boehringer Ingelheim Investigational Site
City
KfarSaba
Country
Israel
Facility Name
1160.46.97209 Boehringer Ingelheim Investigational Site
City
Nazareth
Country
Israel
Facility Name
1160.46.97206 Boehringer Ingelheim Investigational Site
City
Petah Tiqwa
Country
Israel
Facility Name
1160.46.97210 Boehringer Ingelheim Investigational Site
City
Tel Aviv
Country
Israel
Facility Name
1160.46.97204 Boehringer Ingelheim Investigational Site
City
Tel Hashomer, Ramat Gan
Country
Israel
Facility Name
1160.46.97201 Boehringer Ingelheim Investigational Site
City
Zerifin
Country
Israel
Facility Name
1160.46.39011 Boehringer Ingelheim Investigational Site
City
Catania
Country
Italy
Facility Name
1160.46.39015 Boehringer Ingelheim Investigational Site
City
Firenze
Country
Italy
Facility Name
1160.46.39012 Boehringer Ingelheim Investigational Site
City
Palermo
Country
Italy
Facility Name
1160.46.39007 Boehringer Ingelheim Investigational Site
City
Reggio Emilia
Country
Italy
Facility Name
1160.46.39013 Boehringer Ingelheim Investigational Site
City
Verona
Country
Italy
Facility Name
1160.46.39005 Boehringer Ingelheim Investigational Site
City
Vittorio Veneto (TV)
Country
Italy
Facility Name
1160.46.82007 Boehringer Ingelheim Investigational Site
City
Busan
Country
Korea, Republic of
Facility Name
1160.46.82003 Boehringer Ingelheim Investigational Site
City
Goyang-si
Country
Korea, Republic of
Facility Name
1160.46.82008 Boehringer Ingelheim Investigational Site
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
1160.46.82010 Boehringer Ingelheim Investigational Site
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
1160.46.82002 Boehringer Ingelheim Investigational Site
City
Kyunggi-do
Country
Korea, Republic of
Facility Name
1160.46.82004 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1160.46.82005 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1160.46.82006 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1160.46.82009 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1160.46.60001 Boehringer Ingelheim Investigational Site
City
Kelantan Kota Bahru
Country
Malaysia
Facility Name
1160.46.60003 Boehringer Ingelheim Investigational Site
City
Melaka
Country
Malaysia
Facility Name
1160.46.60004 Boehringer Ingelheim Investigational Site
City
Pahang
Country
Malaysia
Facility Name
1160.46.60002 Boehringer Ingelheim Investigational Site
City
Selangor
Country
Malaysia
Facility Name
1160.46.31017 Boehringer Ingelheim Investigational Site
City
Alkmaar
Country
Netherlands
Facility Name
1160.46.31001 Boehringer Ingelheim Investigational Site
City
Amersfoort
Country
Netherlands
Facility Name
1160.46.31010 Boehringer Ingelheim Investigational Site
City
Den Bosch
Country
Netherlands
Facility Name
1160.46.31013 Boehringer Ingelheim Investigational Site
City
Eindhoven
Country
Netherlands
Facility Name
1160.46.31014 Boehringer Ingelheim Investigational Site
City
Heerlen
Country
Netherlands
Facility Name
1160.46.31002 Boehringer Ingelheim Investigational Site
City
Nieuwegein
Country
Netherlands
Facility Name
1160.46.31004 Boehringer Ingelheim Investigational Site
City
Rotterdam
Country
Netherlands
Facility Name
1160.46.31015 Boehringer Ingelheim Investigational Site
City
Zwolle
Country
Netherlands
Facility Name
1160.46.64004 Boehringer Ingelheim Investigational Site
City
Christchurch
Country
New Zealand
Facility Name
1160.46.64003 Boehringer Ingelheim Investigational Site
City
Grafton Auckland
Country
New Zealand
Facility Name
1160.46.64002 Boehringer Ingelheim Investigational Site
City
Otahuhu Auckland
Country
New Zealand
Facility Name
1160.46.64001 Boehringer Ingelheim Investigational Site
City
Takapuna Auckland
Country
New Zealand
Facility Name
1160.46.47001 Boehringer Ingelheim Investigational Site
City
Oslo
Country
Norway
Facility Name
1160.46.47005 Boehringer Ingelheim Investigational Site
City
Trondheim
Country
Norway
Facility Name
1160.46.63001 Boehringer Ingelheim Investigational Site
City
Manila
Country
Philippines
Facility Name
1160.46.63005 Boehringer Ingelheim Investigational Site
City
Muntinlupa
Country
Philippines
Facility Name
1160.46.63003 Boehringer Ingelheim Investigational Site
City
Quezon City
Country
Philippines
Facility Name
1160.46.63004 Boehringer Ingelheim Investigational Site
City
Quezon City
Country
Philippines
Facility Name
1160.46.48004 Boehringer Ingelheim Investigational Site
City
Kielce
Country
Poland
Facility Name
1160.46.48001 Boehringer Ingelheim Investigational Site
City
Krakow
Country
Poland
Facility Name
1160.46.48005 Boehringer Ingelheim Investigational Site
City
Krakow
Country
Poland
Facility Name
1160.46.48003 Boehringer Ingelheim Investigational Site
City
Poznan
Country
Poland
Facility Name
1160.46.48006 Boehringer Ingelheim Investigational Site
City
Warsaw
Country
Poland
Facility Name
1160.46.07021 Boehringer Ingelheim Investigational Site
City
Chelyabinsk
Country
Russian Federation
Facility Name
1160.46.07007 Boehringer Ingelheim Investigational Site
City
Ekaterinburg
Country
Russian Federation
Facility Name
1160.46.07016 Boehringer Ingelheim Investigational Site
City
Krasnodar
Country
Russian Federation
Facility Name
1160.46.07004 Boehringer Ingelheim Investigational Site
City
Kursk
Country
Russian Federation
Facility Name
1160.46.07009 Boehringer Ingelheim Investigational Site
City
Rostov-na-Donu
Country
Russian Federation
Facility Name
1160.46.07024 Boehringer Ingelheim Investigational Site
City
Rostov-na-Donu
Country
Russian Federation
Facility Name
1160.46.07014 Boehringer Ingelheim Investigational Site
City
Ufa
Country
Russian Federation
Facility Name
1160.46.07005 Boehringer Ingelheim Investigational Site
City
Yaroslavl
Country
Russian Federation
Facility Name
1160.46.07006 Boehringer Ingelheim Investigational Site
City
Yaroslavl
Country
Russian Federation
Facility Name
1160.46.65001 Boehringer Ingelheim Investigational Site
City
Singapore
Country
Singapore
Facility Name
1160.46.65002 Boehringer Ingelheim Investigational Site
City
Singapore
Country
Singapore
Facility Name
1160.46.65003 Boehringer Ingelheim Investigational Site
City
Singapore
Country
Singapore
Facility Name
1160.46.42107 Boehringer Ingelheim Investigational Site
City
Banska Bystrica
Country
Slovakia
Facility Name
1160.46.42106 Boehringer Ingelheim Investigational Site
City
Lucenec
Country
Slovakia
Facility Name
1160.46.42102 Boehringer Ingelheim Investigational Site
City
Nitra
Country
Slovakia
Facility Name
1160.46.42103 Boehringer Ingelheim Investigational Site
City
Nove Zamky
Country
Slovakia
Facility Name
1160.46.27001 Boehringer Ingelheim Investigational Site
City
Bryanston
Country
South Africa
Facility Name
1160.46.27013 Boehringer Ingelheim Investigational Site
City
Cape Town
Country
South Africa
Facility Name
1160.46.27007 Boehringer Ingelheim Investigational Site
City
Centurion
Country
South Africa
Facility Name
1160.46.27014 Boehringer Ingelheim Investigational Site
City
Kempton Park
Country
South Africa
Facility Name
1160.46.27015 Boehringer Ingelheim Investigational Site
City
Krugersdorp
Country
South Africa
Facility Name
1160.46.27002 Boehringer Ingelheim Investigational Site
City
Morningside
Country
South Africa
Facility Name
1160.46.27012 Boehringer Ingelheim Investigational Site
City
Plumstead
Country
South Africa
Facility Name
1160.46.27006 Boehringer Ingelheim Investigational Site
City
Sunninghill
Country
South Africa
Facility Name
1160.46.34002 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1160.46.34007 Boehringer Ingelheim Investigational Site
City
Cartagena. Murcia
Country
Spain
Facility Name
1160.46.34009 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1160.46.34015 Boehringer Ingelheim Investigational Site
City
Palma de Mallorca
Country
Spain
Facility Name
1160.46.34014 Boehringer Ingelheim Investigational Site
City
Sabadell - barcelona
Country
Spain
Facility Name
1160.46.34011 Boehringer Ingelheim Investigational Site
City
Valencia
Country
Spain
Facility Name
1160.46.46002 Boehringer Ingelheim Investigational Site
City
Göteborg
Country
Sweden
Facility Name
1160.46.46010 Boehringer Ingelheim Investigational Site
City
Kristianstad
Country
Sweden
Facility Name
1160.46.46001 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
1160.46.46008 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
1160.46.46003 Boehringer Ingelheim Investigational Site
City
Uppsala
Country
Sweden
Facility Name
1160.46.88607 Boehringer Ingelheim Investigational Site
City
ChangHua
Country
Taiwan
Facility Name
1160.46.88604 Boehringer Ingelheim Investigational Site
City
Taipei
Country
Taiwan
Facility Name
1160.46.88606 Boehringer Ingelheim Investigational Site
City
Taipei
Country
Taiwan
Facility Name
1160.46.88608 Boehringer Ingelheim Investigational Site
City
Taipei
Country
Taiwan
Facility Name
1160.46.88609 Boehringer Ingelheim Investigational Site
City
Taipei
Country
Taiwan
Facility Name
1160.46.66007 Boehringer Ingelheim Investigational Site
City
Bangkok
Country
Thailand
Facility Name
1160.46.66010 Boehringer Ingelheim Investigational Site
City
Bangkok
Country
Thailand
Facility Name
1160.46.66001 Boehringer Ingelheim Investigational Site
City
Khon Kaen
Country
Thailand
Facility Name
1160.46.66004 Boehringer Ingelheim Investigational Site
City
Muang Nakhonratchasima
Country
Thailand
Facility Name
1160.46.66005 Boehringer Ingelheim Investigational Site
City
Nakhonratchasima
Country
Thailand
Facility Name
1160.46.66006 Boehringer Ingelheim Investigational Site
City
Nokorn Nayok
Country
Thailand
Facility Name
1160.46.66008 Boehringer Ingelheim Investigational Site
City
Phayathai
Country
Thailand
Facility Name
1160.46.90003 Boehringer Ingelheim Investigational Site
City
Ankara
Country
Turkey
Facility Name
1160.46.90004 Boehringer Ingelheim Investigational Site
City
Ankara
Country
Turkey
Facility Name
1160.46.90001 Boehringer Ingelheim Investigational Site
City
Istanbul
Country
Turkey
Facility Name
1160.46.90002 Boehringer Ingelheim Investigational Site
City
Istanbul
Country
Turkey
Facility Name
1160.46.90007 Boehringer Ingelheim Investigational Site
City
Istanbul
Country
Turkey
Facility Name
1160.46.90008 Boehringer Ingelheim Investigational Site
City
Istanbul
Country
Turkey
Facility Name
1160.46.90009 Boehringer Ingelheim Investigational Site
City
Istanbul
Country
Turkey
Facility Name
1160.46.90010 Boehringer Ingelheim Investigational Site
City
Istanbul
Country
Turkey
Facility Name
1160.46.38005 Boehringer Ingelheim Investigational Site
City
Vinnitsa
Country
Ukraine
Facility Name
1160.46.44005 Boehringer Ingelheim Investigational Site
City
Headington, Oxford
Country
United Kingdom
Facility Name
1160.46.44011 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1160.46.44006 Boehringer Ingelheim Investigational Site
City
Newcastle upon Tyne
Country
United Kingdom
Facility Name
1160.46.44013 Boehringer Ingelheim Investigational Site
City
Plymouth
Country
United Kingdom
Facility Name
1160.46.44012 Boehringer Ingelheim Investigational Site
City
Sheffield
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27807306
Citation
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.
Results Reference
derived
PubMed Identifier
24344086
Citation
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.
Results Reference
derived
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
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.46_U11-2298-01-DS.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.46_Literature.pdf
Description
Related Info

Learn more about this trial

Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)

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