PIIb study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects undergoing Hip Replacement Surgery.
Phase 2
- Registration Number
- CTRI/2009/091/000651
- Lead Sponsor
- Astellas Pharma Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Male or female subject aged 18 years or older.
Subject is scheduled for elective hip replacement surgery.
Exclusion Criteria
- Subject has active bleeding or any condition associated with increased risk of bleeding
- Subject has had major trauma or surgery within 3 months before planned hip replacement surgery or requires major surgery or other invasive procedures with potential for uncontrolled bleeding during the study
- Subject has had an MI or stroke within 3 months before planned hip replacement surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Symptomatic Venous Thromboembolisms and Death from all causes<br>Time Frame: 12 days<br>Timepoint: Time Frame: 12 days<br>
- Secondary Outcome Measures
Name Time Method 1) Incidence of All Venous Thromboembolic events<br>Time Frame : Until day 12, during the treatment period, follow-up period and entire study period<br>2) Incidence of Bleeding events<br>Time Frame : During the treatment period, follow-up period and entire study period<br>Timepoint: Until day 12, during he treatment period, follow-up period and entire study period.