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Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement (PEARL-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00408239
First received: December 4, 2006
Last updated: December 15, 2011
Last verified: December 2011
History of Changes
  Purpose

Evaluate the safety and tolerability of escalating oral doses of YM150 in patients undergoing elective primary total knee replacement surgery


Condition Intervention Phase
Thromboembolism
 Drug: YM150
Drug: enoxaparin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Factor Xa Inhibitor YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement: A Randomized, Enoxaparin-controlled, Open Label, Dose-escalation Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • All clinically relevant bleeds during treatment rated as major or clinically relevant non-major, and/or incidence of death due to any cause during study treatment [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Venous thromboembolism and/or bleeds [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]
  • Other safety assessments [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
  • PK, PD variables [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

Enrollment: 367
Study Start Date: December 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dose regimen 1
 Drug: YM150
Oral
Active Comparator: 2 Drug: enoxaparin
Sub cutaneous
Experimental: 3
Dose regimen 2
 Drug: YM150
Oral

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for elective primary total knee replacement surgery
  • Legal minimum age requirement ( country-specific)
  • Written informed consent has been obtained

Exclusion Criteria:

  • Documented history or considered to be at increased risk of venous thromboembolism

  • Subjects considered to be at increased risk of bleeding:

    • Known hemorrhagic disorder and/or coagulation disorder
    • Thrombocytopenia
    • Clinically important bleeding occurred within 3 months prior to the screening visit
  • Acute bacterial endocarditis
  • Severe hypertension
  • Retinopathy
  • Concomitant use of anticoagulants / antiplatelet agents (including homeopathic drugs) and/or anticipated postoperative need for other reasons than prevention of DVT during the study period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00408239

Locations
Indonesia
Jakarta, Indonesia, 14460
Japan
Chubu region, Japan
Chugoku region, Japan
Kansai region, Japan
Kanto region, Japan
Kyushyu region, Japan
Shikoku region, Japan
Tohoku region, Japan
Korea, Republic of
In Cheon, Korea, Republic of, 405-760
Jeonnam, Korea, Republic of, 519-809
Seoul, Korea, Republic of, 110-744
Malaysia
Kelantan, Malaysia, 16150
Kuala Lumpur, Malaysia, 59100
Philippines
Manila, Philippines, 1008
Quezon City, Philippines, 1114
Singapore
Singapore, Singapore
Taiwan
Kaohsiung, Taiwan, 833
Thailand
Bangkok, Thailand
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00408239     History of Changes
Other Study ID Numbers: 150-CL-029
Study First Received: December 4, 2006
Last Updated: December 15, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare
Korea: Food and Drug Administration
Taiwan: Department of Health
Malaysia: Ministry of Health
Philippines: Department of Health
Singapore: Health Sciences Authority
Thailand: Ministry of Public Health
Indonesia: National Agency of Drug and Food Control

Keywords provided by Astellas Pharma Inc:
Factor Xa inhibitor
Thromboembolism
Arthroplasty
Knee Replacement
Prevention and Control

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