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Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00913120
First received: June 2, 2009
Last updated: June 8, 2010
Last verified: June 2010
History of Changes
  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:

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
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
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

No publications provided

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
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Enoxaparin
 Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013