Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 month Treatment for Acute symptomatic venous thromboembolism (VTE).
Phase 3
Completed
- Conditions
- Health Condition 1: null- Acute symptomatic venous thromboembolism.
- Registration Number
- CTRI/2009/091/000686
- Lead Sponsor
- Boehringer Ingelheim International Traiding Shanghai Co Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2554
Inclusion Criteria
Acute symptomatic uni- or bilateral DVT of the leg involving proximal veins, and/or 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 AST or ALT > 3x ULN or known liver disease expected to have an impact on survival
Severe renal impairment
Patients considered unsuitable for inclusion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A composite of recurrent symptomatic VTE and deaths related to VTE within 6 months (VTE is defined as the composite incidence of DVT of the leg (including the inferior caval vein) and PE).Timepoint: Time Frame: 6 months
- Secondary Outcome Measures
Name Time Method Efficacy: Composite of recurrent symptomatic VTE and all deaths, Symptomatic DVT, Symptomatic PE, Deaths related to VTE, All deaths Safety: Incidence of Bleeding Events, AE, Discontinuation due to AE, Laboratory measures, ACS, vital signs.Timepoint: Time Frame: 6 months