NCT02884206

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 592 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The Screening epoch of approximately 3 weeks was used to assess eligibility. Eligible patients then entered the single-blind treatment run-in epoch (Active Run-In Epoch), which was designed to assess patient's tolerability to study drug and to determine patients who were likely to stay on study drug for the duration of the trial. The treatment run-in consisted of valsartan 40 mg bid (if necessary), followed by valsartan 80 mg bid, and then followed by LCZ696 100 mg bid, over 3 to 8 weeks duration. Patients unable to tolerate either valsartan or LCZ696 at the prescribed doses during the treatment run-in were not eligible for randomization and were discontinued from the study. At randomization (Visit 199/201), eligible patients were randomized 1:1 to receive either LCZ696 200 mg bid or valsartan 160 mg bid (double-blind period). Patients who terminated the study early were expected, and were encouraged, to attend all the protocol specified study visits, to perform all measurements as stipulated in the visit schedule and to remain in follow up for the duration of the trial.

Conditions

• Chronic Heart Failure (CHF)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-11-23
• Primary completion: 2022-05-16
• Completion: 2022-05-16
• First posted: 2016-08-30
• Last updated: 2024-08-06
• Results posted: 2024-08-06

Locations

135 sites across 20 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