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Prevention of Venous Thromboembolism in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower Extremities

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00937911
First received: July 9, 2009
Last updated: June 14, 2010
Last verified: June 2010
History of Changes
  Purpose

The study objective is to evaluate the efficacy and safety of oral YM150 for prevention of venous thromboembolism in subjects undergoing hip fracture surgery or surgery in the lower extremities.


Condition Intervention Phase
Venous Thromboembolism
 Drug: YM150
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: YM150 Phase III Study - An Open-label, Multi-center Study in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower Extremities

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Incidence of venous thromboembolism [ Time Frame: Until day 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of deep vein thrombosis [ Time Frame: Until day 35 ] [ Designated as safety issue: No ]
  • Incidence of pulmonary embolism [ Time Frame: Until day 35 ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: Until day 35 ] [ Designated as safety issue: Yes ]
  • Incidence of bleeding event [ Time Frame: Until day 35 ] [ Designated as safety issue: Yes ]

Enrollment: 101
Study Start Date: June 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YM150 group Drug: YM150
oral

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects undergoing hip fracture surgery or patients undergoing surgery in the lower extremities other than hip fracture 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
  • Subject has uncontrolled severe or moderate hypertension, retinopacy, myocardial infarction or stroke
  • Subject is receiving anticoagulants/antiplatelet agents
  • Subject has a body weight less than 40 kg
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937911

Locations
Japan
Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyusyu, Japan
Shikoku, Japan
Touhoku, Japan
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: NCT00937911     History of Changes
Other Study ID Numbers: 150-CL-041
Study First Received: July 9, 2009
Last Updated: June 14, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
YM150
Bleeding
Anticoagulant
Venous thromboembolism
FXa inhibitor

Additional relevant MeSH terms:
Hip Fractures
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Femoral Fractures
Fractures, Bone
Wounds and Injuries
 Hip Injuries
Leg Injuries
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on May 22, 2013