Trials / Completed
CompletedNCT00133731
The SEPIA-PCI Trial: Otamixaban in Comparison to Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention
A Multinational, Randomized, Double-Blind, Double-Dummy, Exploratory, Parallel Group, Dose-Ranging Phase II Study to Evaluate Pharmacodynamics, Safety and Tolerability, and Pharmacokinetics of Several Intravenous Regimens of Factor Xa Inhibitor Otamixaban (XRP0673), in Comparison to Intravenous Unfractionated Heparin, in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 947 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this dose-ranging study is to determine the effects of several intravenous (IV) regimens of otamixaban on pharmacodynamic markers (including markers of thrombosis and coagulation markers), safety/tolerability, clinical efficacy and pharmacokinetics.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Otamixaban (XRP0673) | |
| DRUG | Unfractionated Heparin | |
| PROCEDURE | Percutaneous Coronary Intervention |
Timeline
- Start date
- 2004-09-01
- Completion
- 2005-10-01
- First posted
- 2005-08-24
- Last updated
- 2008-07-02
Locations
89 sites across 10 countries: United States, Belgium, Canada, Czechia, France, Germany, Netherlands, Slovakia, South Africa, Spain
Source: ClinicalTrials.gov record NCT00133731. Inclusion in this directory is not an endorsement.