drugset / Trial / NCT02468232

Study of Efficacy and Safety of LCZ696 in Japanese Patients With Chronic Heart Failure and Reduced Ejection Fraction

NCT02468232

Phase 3 Completed 225 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study was to assess the effect of LCZ696 at a target dose of 200 mg b.i.d. compared to enalapril 10 mg b.i.d., in addition to the background heart failure (HF) treatment, on delaying time to first occurrence of either cardiovascular (CV) death or HF hospitalization events in Japanese patients with stable chronic heart failure (CHF), New York Heart Association (NYHA) classes II-IV and reduced ejection fraction (left ventricular ejection fraction (LVEF) ≤ 35%).

Timeline

Start
2015-06-15
Primary completion
2019-02-08
Completion
2021-02-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator Enalapril Other / unclassified 10 mg Oral
Subject LCZ696 Unknown 200 mg Oral