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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00244725
Other study ID # ITI101711
Secondary ID
Status Completed
Phase Phase 2
First received October 25, 2005
Last updated April 14, 2015
Start date September 2005
Est. completion date September 2006

Study information

Verified date April 2015
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory AgencyCanada: Health CanadaUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 961
Est. completion date September 2006
Est. primary completion date September 2006
Accepts healthy volunteers No
Gender Both
Age group 35 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Intervention

Drug:
Odiparcil

Warfarin

Coumadin


Locations

Country Name City State
Australia GSK Investigational Site Box Hill Victoria
Australia GSK Investigational Site Camperdown New South Wales
Australia GSK Investigational Site Clayton Victoria
Australia GSK Investigational Site Geelong Victoria
Australia GSK Investigational Site Southport Queensland
Australia GSK Investigational Site Windsor Victoria
Brazil GSK Investigational Site Porto Alegre Rio Grande Do Sul
Brazil GSK Investigational Site Porto Alegre Rio Grande Do Sul
Canada GSK Investigational Site Ajax Ontario
Canada GSK Investigational Site Charlottetown Prince Edward Island
Canada GSK Investigational Site Don Mills Ontario
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Newmarket Ontario
Canada GSK Investigational Site North York Ontario
Canada GSK Investigational Site Oshawa Ontario
Canada GSK Investigational Site Québec Quebec
Canada GSK Investigational Site Sainte Jerome Quebec
Canada GSK Investigational Site Scarborough Ontario
Canada GSK Investigational Site Waterloo Ontario
Canada GSK Investigational Site Winnipeg Manitoba
India GSK Investigational Site Chennai
India GSK Investigational Site Secunderabad
Israel GSK Investigational Site Tel-Aviv
Latvia GSK Investigational Site Riga
Latvia GSK Investigational Site Riga
Lithuania GSK Investigational Site Klaipeda
Lithuania GSK Investigational Site Vilnius
Poland GSK Investigational Site Krakow
Poland GSK Investigational Site Wroclaw
Russian Federation GSK Investigational Site Irkutsk
Russian Federation GSK Investigational Site Kurgan
Russian Federation GSK Investigational Site Moscow
Russian Federation GSK Investigational Site Mosocow
Russian Federation GSK Investigational Site Mosocow
South Africa GSK Investigational Site Centurion
South Africa GSK Investigational Site Pretoria
South Africa GSK Investigational Site Pretoria Gauteng
Ukraine GSK Investigational Site Cherkasy
Ukraine GSK Investigational Site Dnepropetrovsk
Ukraine GSK Investigational Site Kyiv
Ukraine GSK Investigational Site Kyiv
Ukraine GSK Investigational Site Vinnitsa
United Kingdom GSK Investigational Site Birmingham West Midlands
United Kingdom GSK Investigational Site Bournmouth
United Kingdom GSK Investigational Site Fife
United Kingdom GSK Investigational Site London
United Kingdom GSK Investigational Site Wigan
United States GSK Investigational Site Allentown Pennsylvania
United States GSK Investigational Site Altoona Pennsylvania
United States GSK Investigational Site Baltimore Maryland
United States GSK Investigational Site Baton Rouge Louisiana
United States GSK Investigational Site Birmingham Alabama
United States GSK Investigational Site Boise Idaho
United States GSK Investigational Site Camp Hill Pennsylvania
United States GSK Investigational Site Charlotte North Carolina
United States GSK Investigational Site Clearwater Florida
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Decatur Georgia
United States GSK Investigational Site Deland Florida
United States GSK Investigational Site Hershey Pennsylvania
United States GSK Investigational Site Lexington Kentucky
United States GSK Investigational Site Little Rock Arkansas
United States GSK Investigational Site Lubbock Texas
United States GSK Investigational Site Marshfield Wisconsin
United States GSK Investigational Site Mineola New York
United States GSK Investigational Site Mobile Alabama
United States GSK Investigational Site Norfolk Virginia
United States GSK Investigational Site Philadelphia Pennsylvania
United States GSK Investigational Site Phoenix Arizona
United States GSK Investigational Site Richmond Virginia
United States GSK Investigational Site Sacramento California
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site Sarasota Florida
United States GSK Investigational Site Sarsota Florida
United States GSK Investigational Site St. Petersburg Florida
United States GSK Investigational Site Torrance California
United States GSK Investigational Site Warren Michigan
United States GSK Investigational Site Yuba City California

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  India,  Israel,  Latvia,  Lithuania,  Poland,  Russian Federation,  South Africa,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total venous thromboembolism (VTE) event rate after 8 - 12 days of dosing. 12 Days
Secondary 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. 10 Days
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