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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00152971 |
To determine the comparative efficacy and safety of two different doses (75mg day 1 followed by150 m g day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran administered orally (capsules), compared to enoxaparin 30 mg twice a day subcutaneous, in prevention of venous t hromboembolism in patients with primary elective total knee replacement surgery
Condition | Intervention | Phase |
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Arthroplasty, Replacement, Knee Thromboembolism |
Drug: dabigatran |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment |
Official Title: | A Phase III, Randomized, Parallel-Group, Double-Blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens (75mg Day 1 Followed by 150 mg Day 2-Completion, and 110 mg Day 1 Followed by 220 mg Day 2-Completion) of Dabigatran Etexilate Administered Orally (Cap |
Estimated Enrollment: | 2610 |
Estimated Study Completion Date: | November 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA
EXCLUSION CRITERIA
Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Pharmaceuticals |
Study ID Numbers: | 1160.24 |
Study First Received: | September 8, 2005 |
Last Updated: | August 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00152971 |
Health Authority: | United States: Food and Drug Administration |
Embolism and Thrombosis Embolism Vascular Diseases |
Thrombosis Thromboembolism Enoxaparin |
Cardiovascular Diseases |