At a glance
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A Phase 2, Double-blind, Active-controlled, Dose-titrating Efficacy and Safety Study of Firibastat Compared to Ramipril Administered Orally, Twice Daily, Over 12 Weeks to Prevent Left Ventricular Dysfunction After Acute MI
In Brief
A Phase 2 clinical trial evaluating Ramipril and Firibastat for Myocardial Infarction. Completed, enrolled 295 participants across 7 sites in 7 countries.
Detailed Summary
This is a multicenter, randomized, double-blind, active-controlled, dose-titrating phase 2 study to evaluate the safety and efficacy of firibastat administered orally BID (2 daily doses) versus ramipril administered orally BID over 12 weeks after acute anterior MI. Subjects will be followed for 12 weeks (over 4 study visits). A total of 294 male and female subjects with a diagnosis of first acute anterior MI will be randomized. The subjects will need to have a primary percutaneous coronary intervention (PCI) of the index MI related artery within 24 hours after MI.
Study Details
Timeline
Interventions
1 or 2 capsules administered orally, twice daily
1 or 2 capsules administered orally, twice daily