Phase III Study Testing Efficacy & Saftety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp VTE
Tracking Information
Start Date ICMJE | April 2008 |
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Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: July 9, 2008) | 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). [ Time Frame: 6 months ] |
Original Primary Outcome Measures ICMJE (submitted: May 19, 2008) | 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). |
Change History | Complete list of historical versions of study NCT00680186 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: July 9, 2008) | 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. [ Time Frame: 6 months ] |
Original Secondary Outcome Measures ICMJE (submitted: May 19, 2008) | 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. |
Descriptive Information
Brief Title ICMJE | Phase III Stydy Testing Efficacy & Saftety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp VTE |
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Official Title ICMJE | 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 |
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 PRN to maintain an 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. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Thromboembolism |
Intervention ICMJE |
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Recruitment Information
Estimated Enrollment ICMJE | 2554 | ||||
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Completion Date | |||||
Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Australia, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, France, Hungary, India, Israel, Italy, Korea, Republic of, Malaysia, Netherlands, New Zealand, Norway, Philippines, Poland, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00680186 | ||||
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Responsible Party | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim | ||||
Study ID Numbers ICMJE | 1160.46, EudraCT : 2007-002631-86 | ||||
Study Sponsor ICMJE | Boehringer Ingelheim Pharmaceuticals | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Boehringer Ingelheim Pharmaceuticals |
Source: http://clinicaltrials.gov/