A Phase IIb, Randomized, Parallel Group, Double-Blind, Double-Dummy, Multi-Center, Multi-National, Multi-Dose, Study of DU-176b Compared to Dalteparin in Patients Undergoing Elective Unilateral Total Hip Replacement
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Daiichi Sankyo
- Enrollment
- 903
- Locations
- 29
- Primary Endpoint
- Adjudicated Incidence of VTE
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years of age or older; male or female.
- •Able to provide written informed consent.
- •Must be scheduled for elective unilateral total hip replacement surgery. Only primary surgeries accepted.
- •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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Adjudicated Incidence of VTE
Time Frame: end of treatment
Assess the efficacy of DU-176b in the prevention of venous thromboembolism (VTE) from 6 to 8 hours after hip replacement surgery to 7 to 10 days after the surgery. A subject was judged to have a VTE if one or more of the following criteria were met: * Observed lower extremity deep vein thrombosis (DVT) (either proximal, distal, or both ) as assessed by bilateral or unilateral ascending contrast venography prior to or at the end-of-treatment (EOT) visit * Symptomatic and objectively proven pulmonary embolism prior to or at the EOT visit * Symptomatic and objectively proven DVT prior to or at EOT visit end of treatment defined as 6 to 8 hours after after hip replacement surgery to 7 to 10 days after the surgery.
Secondary Outcomes
- Change in Prothrombin Time (PT) From Baseline(end of treatment)
- Change in Activated Partial Thromboplastin Time (aPTT) From Baseline(end of treatment)
- Adjudicated Incidence of Major or Clinically Relevant Non-major Bleeding Events(10 days after first dose)