A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement Surgery
(ONYX-3 Trial)
Recruiting in Palo Alto (17 mi)
+143 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Waitlist Available
Sponsor: Astellas Pharma Europe B.V.
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The purpose of this study is to evaluate the efficacy and safety of various doses of YM150 (the experimental drug) compared to enoxaparin in the prevention of venous thromboembolism in patients that are undergoing elective hip replacement surgery.
Eligibility Criteria
Inclusion Criteria
Subject is scheduled for elective hip replacement surgery
Treatment Details
Interventions
- Enoxaparin (Anticoagulant)
- YM150 (Anticoagulant)
Participant Groups
5Treatment groups
Experimental Treatment
Active Control
Group I: 4. YM150, Dose Y, once dailyExperimental Treatment1 Intervention
Group II: 3. YM150, Dose Y, twice dailyExperimental Treatment1 Intervention
Group III: 2, YM150, Dose X, once dailyExperimental Treatment1 Intervention
Group IV: 1. YM150, Dose X, twice dailyExperimental Treatment1 Intervention
Group V: 5. EnoxaparinActive Control1 Intervention
Enoxaparin is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Lovenox for:
- Deep vein thrombosis
- Pulmonary embolism
- Acute coronary syndromes
🇪🇺 Approved in European Union as Clexane for:
- Deep vein thrombosis
- Pulmonary embolism
- Acute coronary syndromes
- Prevention of venous thromboembolism in surgical patients
🇨🇦 Approved in Canada as Lovenox for:
- Deep vein thrombosis
- Pulmonary embolism
- Acute coronary syndromes
🇦🇺 Approved in Australia as Clexane for:
- Deep vein thrombosis
- Pulmonary embolism
- Acute coronary syndromes
- Prevention of venous thromboembolism in surgical patients
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NCT00902928Baltimore, MD
NCT00902928Phoenix, AZ
NCT00902928Long Beach, CA
NCT00902928Thunder Bay, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Astellas Pharma Europe B.V.Lead Sponsor