NCT00595426CompletedPhase 2
A Phase 2b, Double-Blind, Double-Dummy, Randomized, Parallel Group Study to Evaluate the Safety and Efficacy of Twice Daily Dosing and Once Daily Dosing of YM150 in Subjects Undergoing Primary Elective Knee Arthroplasty
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 685
- Primary Endpoint
- The incidence of total venous thromboembolisms (VTE).
Study Overview
Brief Summary
To evaluate the safety and efficacy of twice daily dosing and once daily dosing of YM150 in subjects undergoing primary elective knee replacement surgery
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is scheduled for elective primary knee arthroplasty
- •Written Informed consent obtained
Exclusion Criteria
- •Subject has documented history of previous VTE
- •Subject is considered to be at increased risk of VTE
- •Subject has active bleeding or any condition associated with increased risk of bleeding
- •Subject is planning to have surgery on the contralateral knee at the same time or within 6 weeks after enrollment into the study
Arms & Interventions
1. YM150 Dose X, twice daily
Experimental
Intervention: YM150 (Drug)
2. YM150 Dose Y, once daily
Experimental
Intervention: YM150 (Drug)
3. YM150 Dose Y, twice daily
Experimental
Intervention: YM150 (Drug)
4. YM150 Dose Z, once daily
Experimental
Intervention: YM150 (Drug)
5. Warfarin
Active Comparator
various doses
Intervention: Warfarin (Drug)
Outcomes
Primary Outcomes
The incidence of total venous thromboembolisms (VTE).
Time Frame: 6 Weeks
The incidence of bleeding events classified as major by the Adjudication Committee
Time Frame: 6 Weeks
Secondary Outcomes
- Evaluation of efficacy variables including: Proximal VTE, Distal VTE, Confirmed symptomatic VTE, death due to any cause(6 Weeks)
- Incidence of the bleeding types: major, clinically relevant nonmajor, minor(6 Weeks)
Investigators
Similar Trials
Completed
Phase 2
A Study Evaluating Safety and Tolerability of YM150 Compared to Warfarin in Subjects With Atrial FibrillationAtrial FibrillationNCT00938730Astellas Pharma Inc1,280
Completed
Phase 2
A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement SurgeryArthroplasty, Replacement, HipVenous ThromboembolismNCT00902928Astellas Pharma Europe B.V.1,992
Completed
Phase 2
Study Evaluating Safety, Tolerability and Efficacy of YM150 in Subjects With Acute Coronary SyndromesAcute Coronary SyndromeNCT00994292Astellas Pharma Europe B.V.1,276
Completed
Phase 2
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement SurgeryVenous ThromboembolismNCT00917254Astellas Pharma Inc369
Completed
Phase 2
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement SurgeryVenous ThromboembolismNCT00913120Astellas Pharma Inc610