CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 592 enrolled
Drug / intervention
LCZ696 +3 moredrug
Likely dose
LCZ696 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02884206
NCT02884206Phase 3Completed
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A Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Effects of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction

Novartis Pharmaceuticals·interventional·Posted Aug 30, 2016·Updated Aug 6, 2024

In Brief

A Phase 3 clinical trial evaluating LCZ696, Valsartan, and 2 other interventions for Chronic Heart Failure (CHF). Completed, enrolled 592 participants across 135 sites in 20 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Heart Failure (CHF)
CountriesArgentina, Australia, Belgium, Bulgaria, Canada, Croatia, France, Germany, Italy, Lithuania, Netherlands, Poland, Russia, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 30, 2016
Enrollment StartNov 23, 2016
Primary CompletionMay 16, 2022
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 9.8 years ago

Interventions

LCZ696drug

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

Valsartandrug

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

Placebo of LCZ696drug

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

Placebo of Valsartandrug

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