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

NCT02468232 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2023-12-08

Study results available
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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%).

Conditions

  • Heart Failure With Reduced Ejection Fraction (HF-rEF)

Interventions

DRUG

LCZ696

The target dose during the study was LCZ696 200 mg bid given orally. LCZ696 was supplied as 50 mg, 100 mg and 200 mg film-coated tablets.

DRUG

Enalapril

The target dose during the study was enalapril 10 mg bid given orally. Enalapril was provided as 2.5 mg, 5 mg, and 10 mg tablets.

DRUG

Placebo to LCZ696

LCZ696 Placebo 50 mg, 100 mg and 200 mg film-coated tablets

DRUG

Placebo to Enalapril

Enalapril Placebo 2.5 mg, 5 mg and 10 mg tablets

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02468232 on ClinicalTrials.gov