We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00408239
First Posted: December 6, 2006
Last Update Posted: December 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

Secondary Outcome Measures:
  • Venous thromboembolism and/or bleeds [ Time Frame: 2 Weeks ]
  • Other safety assessments [ Time Frame: 2 Weeks ]
  • PK, PD variables [ Time Frame: 2 Weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): 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

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00408239     History of Changes
Other Study ID Numbers: 150-CL-029
First Submitted: December 4, 2006
First Posted: December 6, 2006
Last Update Posted: December 19, 2011
Last Verified: December 2011

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

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