Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE, a Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement

Completed · Phase 3

Conditions studied: Prevention, Venous Thromboembolism

In brief

The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and can help prevent blood clots forming after a hip replacement operation.

Key facts

Study ID

NCT00332020

Run by

Bayer

People needed

2457

Starts

2006-02-01

Expected to finish

2007-06-01

Last updated by the study team

2015-01-27

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 hip replacement

You may not qualify if…

• Planned, staged total bilateral hip replacement
• Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin
• Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin
• Conditions prohibiting bilateral venography (e.g. amputation of one leg, allergy to contrast media)

Where it is running

• Study site — Denver, Colorado, United States
• Study site — Bay Pines, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Canberra, Australian Capital Territory, Australia
• Study site — Lismore, New South Wales, Australia
• Study site — Sydney, New South Wales, Australia
• Study site — Southport, Queensland, Australia
• Study site — Geelong, Victoria, Australia
• Study site — Melbourne, Victoria, Australia
• Study site — Belo Horizonte, Minas Gerais, Brazil
• Study site — Belo Horizonte, Minas Gerais, Brazil
• Study site — Curitiba, Paraná, Brazil
• Study site — Passo Fundo, Rio Grande do Sul, Brazil
• Study site — Batatais, São Paulo, Brazil
• Study site — Marília, São Paulo, Brazil
• Study site — São Paulo, São Paulo, Brazil
• Study site — São Paulo, São Paulo, Brazil
• Study site — São Paulo, São Paulo, Brazil
• Study site — Rio de Janeiro, Brazil
• Study site — Red Deer, Alberta, Canada
• Study site — Penticton, British Columbia, Canada
• Study site — Winnipeg, Manitoba, Canada
• Study site — Saint John, New Brunswick, Canada
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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