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Odiparcil For The Prevention Of Venous Thromboembolism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00244725
First received: October 25, 2005
Last updated: November 21, 2012
Last verified: November 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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: 915
Study Start Date: September 2005
Intervention Details:
    Drug: Odiparcil Drug: Warfarin Drug: Coumadin
    Other Names:
    • Coumadin
    • Warfarin
    • Odiparcil
  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00244725

  Show 79 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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: November 21, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 22, 2013