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The SEPIA-PCI Trial: Otamixaban in Comparison to Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention

NCT00133731 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 947

Last updated 2008-07-02

No results posted yet for this study

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

  • Angioplasty, Transluminal, Percutaneous Coronary

Interventions

DRUG

Otamixaban (XRP0673)

DRUG

Unfractionated Heparin

PROCEDURE

Percutaneous Coronary Intervention

Sponsors & Collaborators

Principal Investigators

  • ICD CSD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Completion
2005-10-31

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Netherlands
  • Slovakia
  • South Africa
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00133731 on ClinicalTrials.gov