Secondary Prevention of Venous Thrombo Embolism 


Tracking Information

Start Date  ICMJEMay 2006
Estimated Primary Completion DateJuly 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2008)
Composite of recurrent symptomatic venous thromboembolism (VTE) and deaths related to VTE during the treatment period. VTE is defined as the composite incidence of Deep Venous Thromboembolism and Pulmonary Embolism. [ Time Frame: 18 months ]
Original Primary Outcome Measures ICMJE 
 (submitted: May 23, 2006)
Composite of recurrent symptomatic venous thromboembolism (VTE) and deaths related to VTE during the treatment period. VTE is defined as the composite incidence of Deep Venous Thromboembolism and Pulmonary Embolism.
Change HistoryComplete list of historical versions of study NCT00329238 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: October 6, 2008)
1. Composite of recurrent symptomatic VTE and all deaths 2. Symptomatic DVT 3. Symptomatic PE 4. Deaths related to VTE 5. All deaths [ Time Frame: 18 months ]
Original Secondary Outcome Measures ICMJE 
 (submitted: May 23, 2006)
1. Composite of recurrent symptomatic VTE and all deaths 2. Symptomatic DVT 3. Symptomatic PE 4. Deaths related to VTE 5. All deaths

Descriptive Information

Brief Title  ICMJESecondary Prevention of Venous Thrombo Embolism.
Official Title  ICMJEA Randomised, Multicenter, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Dabigatran Etexilate, 150 mg b.i.d Administered Orally (Capsules) for 18 Months, Compared to Warfarin Tablets p.r.n. (Target INR) for the Secondary Prevention of Venous Thromboembolism.
Brief Summary

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

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEThromboembolism
Intervention  ICMJEDrug: warfarin

Recruitment Information

Estimated Enrollment  ICMJE2700
Completion Date 
Estimated Primary Completion DateJuly 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Inclusion_Criteria
  • Acute symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) 3-6 months prior to screening, which has been documented by objective testing

Exclusion Criteria:

- Symptomatic DVT or PE at screening Interruption of anticoagulant therapy for 2 or more weeks during the 3-6 months of treatment for the prior VTE. Patients who in the investigators judgement are perceived as having an excessive risk of bleeding Elevated AST or ALT > 2x ULN Severe renal impairment (estimated creatinine clearance <= 30 ml/min)

GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Boehringer Ingelheim Study Coordinator1-800-243-0127clintriage.rdg@boehringer-ingelheim.com
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   China,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Italy,   Mexico,   Netherlands,   New Zealand,   Norway,   Poland,   Portugal,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Turkey,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00329238
Responsible PartyBoehringer Ingelheim, Study Chair, Boehringer Ingelheim
Study ID Numbers  ICMJE1160.47
Study Sponsor  ICMJEBoehringer Ingelheim Pharmaceuticals
Collaborators  ICMJE 
Investigators  ICMJE
Study Chair:Boehringer IngelheimBoehringer Ingelheim Pharmaceuticals
Information Provided ByBoehringer Ingelheim Pharmaceuticals