MedTrace Logo

A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients

NCT03066804 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2572

Last updated 2021-10-11

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to demonstrate the superiority of LCZ696 over individualized medical therapy for comorbidities in reducing N-terminal pro-brain natriuretic peptide (NT-proBNP) and improving exercise capacity and HF symptoms in patients with heart failure with preserved ejection fraction (HFpEF).

Conditions

Interventions

DRUG

sacubitril/valsartan

Sacubitril/valsartan is available as 24 mg/26 mg, 49 mg/51 mg, 97 mg/103 mg, respectively in tablet form to be taken orally

DRUG

Enalapril

Enalapril is available as 2.5 mg, 5 mg, and 10 mg tablet form to be taken orally

DRUG

Valsartan

Valsartan is available as 40 mg, 80 mg, 160 mg tablet form to be taken orally

DRUG

Placebo to match sacubitril/valsartan

Placebo to match LCZ696 50 mg, 100 mg, 200 mg tablet form to be taken orally

DRUG

Placebo to match enalapril

Placebo to match enalapril 2.5 mg, 5 mg, 10 mg tablet form to be taken orally

DRUG

Placebo to match valsartan

Placebo to match valsartan 40 mg, 80 mg, 160 mg tablet form to be taken orally

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-22
Primary Completion
2019-10-28
Completion
2019-10-28
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Colombia
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Guatemala
  • Hungary
  • India
  • Israel
  • Italy
  • Latvia
  • Lithuania
  • Mexico
  • Netherlands
  • Peru
  • Portugal
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • Spain
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
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 NCT03066804 on ClinicalTrials.gov