Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery
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ClinicalTrials.gov Identifier: NCT00913120 |
Recruitment Status :
Completed
First Posted : June 3, 2009
Last Update Posted : June 9, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Venous Thromboembolism | Drug: YM150 Drug: Placebo Drug: Enoxaparin | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 610 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Phase II/III Study of YM150 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients Undergoing Elective Total Hip Replacement Surgery |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | March 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: YM150 group-1
YM150 low dose group
|
Drug: YM150
oral |
Experimental: YM150 group-2
YM150 high dose group
|
Drug: YM150
oral |
Placebo Comparator: Placebo group |
Drug: Placebo
oral |
Active Comparator: Enoxaparin group |
Drug: Enoxaparin
injection |
- Overall incidence of venous thromboembolism [ Time Frame: For 2 weeks ]
- Incidence of individual venous thromboembolism [ Time Frame: For 2 weeks ]
- Incidence of bleeding events [ Time Frame: For 2 weeks ]

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects is scheduled for elective primary total hip replacement surgery
- Written informed consent obtained before screening
Exclusion Criteria:
- Subject has history of deep vein thrombosis and/or pulmonary embolism
- Subject has a hemorrhagic disorder and/or coagulation disorder
- Subject has had clinically important bleeding occurred within 90 days prior to the screening visit
- Subject has an acute bacterial endocarditis, retinopathy, hypertension, or thrombocytopenia
- Subject is receiving anticoagulants/antiplatelet agents

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913120
Japan | |
Chubu, Japan | |
Chugoku, Japan | |
Hokkaido, Japan | |
Kansai, Japan | |
Kantou, Japan | |
Kyusyu, Japan | |
Shikoku, Japan | |
Touhoku, Japan | |
Korea, Republic of | |
Daegu, Korea, Republic of | |
Jeonnam, Korea, Republic of | |
Seoul, Korea, Republic of | |
Taiwan | |
Changhua, Taiwan | |
Chiayi, Taiwan | |
Taichung, Taiwan | |
Thailand | |
Bangkok, Thailand | |
Chiangmai, Thailand |
Study Chair: | Use Central Contact | Astellas Pharma Inc |
Responsible Party: | Director, Astellas Pharma, Inc |
ClinicalTrials.gov Identifier: | NCT00913120 |
Other Study ID Numbers: |
150-CL-027 |
First Posted: | June 3, 2009 Key Record Dates |
Last Update Posted: | June 9, 2010 |
Last Verified: | June 2010 |
YM150 FXa inhibitor Thrombosis |
Anticoagulant Venous thromboembolism Arthroplasty, replacement, hip |
Thromboembolism Venous Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
Enoxaparin Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |