A Study of DU-176b in Preventing Blood Clots After Hip Replacement Surgery

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Thrombosis; Hip Replacement

Treatments: Drug: DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT00398216

DU176b-PRT011

2006-000758-29 (EudraCT Number)

Details and patient eligibility

About

This study is to assess if DU176b is effective in prevention of blood clots following hip replacement surgery. The duration is 7-10 days of treatment and 30 and 60 day follow-up visits.

Enrollment: 903 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. 18 years of age or older; male or female.
2. Able to provide written informed consent.
3. Must be scheduled for elective unilateral total hip replacement surgery. Only primary surgeries accepted.
4. If female, must be either one year post-menopausal, surgically sterile, or using medically accepted contraceptive measures as judged by the Investigator and in accordance with local regulatory requirements.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind