Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.

Completed · Phase 3 · Has a placebo group

Conditions studied: Venous Thromboembolism

In brief

The purpose of this study is to assess if 10 mg BAY59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.

Key facts

Study ID

NCT00362232

Run by

Bayer

People needed

3148

Starts

2006-06-01

Expected to finish

2008-01-01

Last updated by the study team

2014-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients aged 18 years or above
• Patients scheduled for elective total knee replacement

You may not qualify if…

• Active bleeding or high risk of bleeding contraindicating treatment with Low Molecular Weight Heparin (LMWH)
• Contraindication listed in the labeling or conditions precluding subject treatment with enoxaparin or requiring dose adjustment (e.g. severe renal impairment, please refer to the local label of enoxaparin in your country)
• Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)

Where it is running

• Study site — Tuscaloosa, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Bakersfield, California, United States
• Study site — Encinitas, California, United States
• Study site — Fountain Valley, California, United States
• Study site — La Jolla, California, United States
• Study site — Torrance, California, United States
• Study site — Yuba City, California, United States
• Study site — Centennial, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Englewood, Colorado, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — DeLand, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Pinellas Park, Florida, United States
• Study site — Decatur, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Meridian, Idaho, United States
• Study site — Towson, Maryland, United States
• Study site — Missoula, Montana, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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