A Dose Ranging Trial for the Evaluation of the Safety, Tolerability and Efficacy of Odiparcil in the Prevention of Venous Thromboembolism Following Total Knee Replacement Surgery
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 961
- Locations
- 101
- Primary Endpoint
- Percentage of Participants With Total VTE Event Over 10 ± 2 Days of Treatment
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Percentage of Participants With Total VTE Event Over 10 ± 2 Days of Treatment
Time Frame: Up to Visit 7 (10 ± 2 days of treatment)
Participants were assessed for VTE at all study visits and at the end of study (Day 10±2) or at early withdrawal. Any participant who remained asymptomatic for VTE at the end of the study did not receive a mandatory bilateral venogram following at least 8 days on study medication. Participants who were withdrawn early and had been objectively confirmed to have a VTE event by a method other than venography were not required to undergo venography. A participant was included in the Independent Central Adjudication Committee (ICAC)-adjudicated incidence of total VTE if he/ she experienced any of adjudicated asymptomatic deep vein thrombosis (DVT) at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or pulmonary embolism (PE) at any time during study treatment or death adjudicated to be related to VTE during study treatment.
Secondary Outcomes
- Percentage of Participants With Proximal DVT Over 10 ± 2 Days of Treatment(Up to 12 days)
- Percentage of Participants With Distal DVT Over 10 ± 2 Days of Treatment(Up to 12 days)
- Percentage of Participants With PE Over 10 ± 2 Days of Treatment(Up to 12 days)
- Number of Death Due to VTE Over 10 ± 2 Days of Treatment(Up to 12 days)
- Percentage of Participants With Total Asymptomatic VTE Over 10 ± 2 Days of Treatment(Up to 12 days)
- Percentage of Total Symptomatic VTE Over 10 ± 2 Days of Treatment(Up to 12 days)
- Concentration of Trough Anti-IIa Activity Over the Duration of Treatment and Follow-up(Up to 68 days)
- Percentage of Participants With Major Bleeds Over 10 ± 2 Days of Treatment(Up to 12 days)
- Percentage of Participants With VTE and/or Major Bleeding Over 10±2 Days of Treatment(Up to 12 days)
- Percentage of Participants With Total VTE Any Time After Start of Treatment(Up to Visit 9 (Day 28 post treatment))
- Percentage of Participants With Elevated Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Direct Bilirubin (DB) and Total Bilirubin (TB) by 2 Fold and 3 Fold From Upper Normal Limits (ULN) Any Time On-treatment(Up to 12 days)