BIBR 1048 in the Prevention of Venous Thromboembolism in Patients Undergoing Primary Elective Total Hip Replacement Surgery
NCT02170701 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 289
Last updated 2018-08-31
Summary
* To determine the therapeutic window of BIBR 1048 in order to select doses for further studies in the development plan.
* Twice daily regimen will be tested for most dose levels and once daily administration will also be evaluated when appropriate.
Conditions
- Venous Thromboembolism
Interventions
- DRUG
-
BIBR 1048
Ascending doses (in mg) given twice daily
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2000-10-31
- Primary Completion
- 2001-06-30
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