PARADISE-MI
ClinicalTrials.gov Identifier: NCT02752737
Full Title
A Multi-center, Randomized, Double-blind, Active-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Ramipril on Morbidity and Mortality in High Risk Patients Following an AMI
Sponsor: Novartis
Condition: Acute Myocardial Infarction
Interventional (CTIMP): Phase 3 Clinical Trial
Treatments:
Drug:Placebo of LCZ696
Drug:Placebo of valsartan
Drug:Valsartan
Drug:Placebo of ramipril
Drug:Ramipril
Drug:LCZ696 (sacubitril/valsartan)
Purpose
To evaluate the efficacy and safety of LCZ696 titrated to a target dose of 200 mg twice daily, compared to ramipril titrated to a target dose of 5 mg twice daily, in addition to conventional post-AMI treatment, in reducing the occurrence of composite endpoint of CV death, HF hospitalization and outpatient HF (time-to-first event analysis) in post-AMI patients with evidence of LV systolic dysfunction and/or pulmonary congestion, with no known prior history of chronic HF.
More information via
Novartis Website
clinicaltrials.gov