Tracking Information
| Start Date ICMJE | May 2006 |
|---|---|
| Estimated Primary Completion Date | July 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 History | Complete 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 ICMJE | Secondary Prevention of Venous Thrombo Embolism. |
|---|---|
| Official Title ICMJE | A 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 Phase | Phase III |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Parallel Assignment, Safety/Efficacy Study |
| Condition ICMJE | Thromboembolism |
| Intervention ICMJE | Drug: warfarin |
Recruitment Information
| Estimated Enrollment ICMJE | 2700 | ||||
|---|---|---|---|---|---|
| Completion Date | |||||
| Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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) | ||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Slovakia, South Africa, Spain, Sweden, Turkey, Ukraine, United Kingdom |
Administrative Information
| NCT ID ICMJE | NCT00329238 | ||||
|---|---|---|---|---|---|
| Responsible Party | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim | ||||
| Study ID Numbers ICMJE | 1160.47 | ||||
| Study Sponsor ICMJE | Boehringer Ingelheim Pharmaceuticals | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Boehringer Ingelheim Pharmaceuticals |