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

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

Outcome

Missed primary endpoint

registry analysis (superiority test); LCZ696 vs Enalapril; p = 0.6260; Hazard Ratio (HR) 1.0881 (95% CI 0.6501 to 1.8212); Regression, Cox NCT02468232 ↗

Drugs

Indications