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Efficacy and Safety of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction

NCT02884206 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 592

Last updated 2024-08-06

Study results available
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Summary

This study was a multi-center, randomized, double-blind, parallel group, active comparator trial designed to evaluate the overall effect of LCZ696 compared to valsartan on cognitive function as assessed by the CogState comprehensive cognitive battery in patients with Heart failure and preserved ejection fraction (HFpEF).

Conditions

  • Chronic Heart Failure (CHF)

Interventions

DRUG

LCZ696

LCZ696 50, 100, and 200 mg tablets taken orally twice daily with matching placebo for valsartan

DRUG

Valsartan

Valsartan 40, 80, and 160 mg tablets taken orally twice daily with matching placebo for LCZ696

DRUG

Placebo of LCZ696

Placebo to match LCZ696 50 mg, 100 mg, and 200 mg tablets

DRUG

Placebo of Valsartan

Placebo to match valsartan 40 mg, 80 mg, and 160 mg tablets

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-23
Primary Completion
2022-05-16
Completion
2022-05-16

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Bulgaria
  • Canada
  • Croatia
  • France
  • Germany
  • Italy
  • Lithuania
  • Netherlands
  • Poland
  • Russia
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

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 NCT02884206 on ClinicalTrials.gov