Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery - Full Text View

Purpose

The purpose of this study is to examine the superiority of YM150 to the placebo and to evaluate the dose-dependent response of YM150 in patients undergoing elective total hip replacement surgery.

Condition	Intervention	Phase
Venous Thromboembolism	Drug: YM150 Drug: Placebo Drug: Enoxaparin	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Hip Replacement

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Overall incidence of venous thromboembolism [ Time Frame: For 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of individual venous thromboembolism [ Time Frame: For 2 weeks ] [ Designated as safety issue: No ]
Incidence of bleeding events [ Time Frame: For 2 weeks ] [ Designated as safety issue: Yes ]


Enrollment:	610
Study Start Date:	May 2009
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	20 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913120

Locations


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

Sponsors and Collaborators

Astellas Pharma Inc

Investigators


Study Chair:	Use Central Contact	Astellas Pharma Inc

More Information


Responsible Party:	Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier:	NCT00913120 History of Changes
Other Study ID Numbers:	150-CL-027
Study First Received:	June 2, 2009
Last Updated:	June 8, 2010
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency Taiwan: Department of Health Korea: Food and Drug Administration Thailand: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:


YM150 FXa inhibitor Thrombosis	Anticoagulant Venous thromboembolism Arthroplasty, replacement, hip

Additional relevant MeSH terms:


Thromboembolism Venous Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Darexaban Factor Xa Inhibitors	Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticoagulants

ClinicalTrials.gov processed this record on September 23, 2016