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Odiparcil For The Prevention Of Venous Thromboembolism

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: October 25, 2005
Last updated: April 14, 2015
Last verified: April 2015
Odiparcil is being studied to determine if it can prevent blood clots from forming after a total knee replacement and also to prove that odiparcil is safe.

Condition Intervention Phase
Fibrillation, Atrial
Deep Vein Thrombosis
Pulmonary Embolism
Venous Thromboembolism
Drug: Odiparcil
Drug: Warfarin
Drug: Coumadin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Dose Ranging Trial for the Evaluation of the Safety, Tolerability and Efficacy of Odiparcil in the Prevention of Venous Thromboembolism Following Total Knee Replacement Surgery

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Total venous thromboembolism (VTE) event rate after 8 - 12 days of dosing. [ Time Frame: 12 Days ]

Secondary Outcome Measures:
  • Relative risk of VTE at Day 10. VTE event rate for odiparcil at Day 10. Pharmacodynamic effect as measured by anti-IIa activity at Days 1, 3, 5 and 10. Measurements of LFTs and major bleeding anytime during the trial. [ Time Frame: 10 Days ]

Enrollment: 961
Study Start Date: September 2005
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Odiparcil Drug: Warfarin Drug: Coumadin
    Other Names:
    • Warfarin
    • Odiparcil

Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Women must be unable to have children.
  • Will have a total knee replacement.

Exclusion Criteria:

  • Allergic to any X-ray dye.
  • Allergies or reactions to warfarin or coumadin.
  • Previous VTE (venous thromboembolism) or deep vein thrombosis (DVT).
  • On anticoagulation therapy.
  • Renal impairment.
  • Participated in any clinical trial in the past 30 days.
  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 identifier: NCT00244725

  Show 79 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00244725     History of Changes
Other Study ID Numbers: ITI101711
Study First Received: October 25, 2005
Last Updated: April 14, 2015

Keywords provided by GlaxoSmithKline:
total knee replacement
Venous thromboembolism
pulmonary embolism
deep vein thrombosis

Additional relevant MeSH terms:
Venous Thrombosis
Venous Thromboembolism
Pulmonary Embolism
Atrial Fibrillation
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Anticoagulants processed this record on April 27, 2017