drugset / Trial / NCT01356992

Patients With High-risk Acute Coronary Syndrome Without ST-segment Elevation

NCT01356992

Phase 3 Terminated 62 enrolled Eurofarma Laboratorios S.A.
RandomizedParallel-groupOpen-labelTreatment

Summary

This non-inferiority study aims at comparing Versa® to the reference enoxaparin (Clexane®, Sanofi-Aventis) in patients with high-risk unstable angina and NSTEMI. The main justification is the search for scientific evidence to prove the Versa® effectiveness for this new therapeutic indication, since it is a product with potential for reducing costs, with effectiveness and safety comparable to the reference drug.

Timeline

Start
2012-07
Primary completion
2013-07
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Enoxaparin sodium Other / unclassified 1 mg/kg Subcutaneous