Odiparcil For The Prevention Of Venous Thromboembolism

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov 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
Endpoint Classification: Safety/Efficacy Study
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:
    • Coumadin
    • Warfarin
    • Odiparcil

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00244725

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00244725     History of Changes
Other Study ID Numbers: ITI101711
Study First Received: October 25, 2005
Last Updated: April 14, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Venous Thromboembolism
Venous Thrombosis
Atrial Fibrillation
Pulmonary Embolism
Arrhythmias, Cardiac
Cardiovascular Diseases
Embolism and Thrombosis
Heart Diseases
Lung Diseases
Pathologic Processes
Respiratory Tract Diseases
Vascular Diseases
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 08, 2015