Odiparcil For The Prevention Of Venous Thromboembolism - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00244725

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
Venous Thromboembolism Deep Vein Thrombosis Pulmonary Embolism	Drug: Odiparcil Drug: Warfarin Drug: Coumadin	Phase II

MedlinePlus related topics: Blood Thinners Deep Vein Thrombosis Knee Replacement Pulmonary Embolism

Drug Information available for: Warfarin Warfarin potassium Warfarin sodium Odiparcil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Single Group Assignment, Safety/Efficacy Study
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

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

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 82 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	ITI101711, TOPVENT
Study First Received:	October 25, 2005
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00244725
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

deep vein thrombosis
pulmonary embolism
DVT
VTE

PE
total knee replacement
Venous thromboembolism

Study placed in the following topic categories:

Embolism and Thrombosis
Pulmonary Embolism
Respiratory Tract Diseases
Embolism
Lung Diseases
Vascular Diseases

Venous Thrombosis
Warfarin
Venous Thromboembolism
Thromboembolism
Thrombosis

Additional relevant MeSH terms:

Anticoagulants
Therapeutic Uses
Hematologic Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009