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NCT02884206 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 592
- Enrollment target
NCT02884206: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT02884206 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 592 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02884206, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 592 participants
- Enrollment target
Study 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).
Primary Outcome
The CogState cognitive battery was composed of 7 tests, which were administered electronically by the patients at scheduled visits. For each test, a standardized z-score was calculated. The GCCS was the average of the non-missing individual test z-scores. A higher score indicated better cognitive function. CogState GCCS changes from baseline (randomization) were analyzed using a repeated measures ANCOVA in which treatment, age stratification factor, Mini mental state examination stratification
Interventions
- DRUG Valsartan
- DRUG LCZ696
- DRUG Placebo of LCZ696
- DRUG Placebo of Valsartan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 592 participants |
| Start Date | 2016-11-23 |
| Est. Completion | 2022-05-16 |
| Phase | Phase 3 |
What the finished NCT02884206 record still lists
NCT02884206 is an interventional study that assigns participants to a tested intervention. The registered 592 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 4 interventions - of which Valsartan is the first listed.
NCT02884206 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02884206 about?
NCT02884206 is a clinical study titled "Efficacy and Safety of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction". 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 ejec...
What is the current status of trial NCT02884206?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 592 participants. The study started on 2016-11-23. Estimated completion is 2022-05-16.
What interventions are being tested in trial NCT02884206?
The interventions under investigation include: Valsartan (DRUG), LCZ696 (DRUG), Placebo of LCZ696 (DRUG), Placebo of Valsartan (DRUG).
Who is sponsoring clinical trial NCT02884206?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02884206's enrollment target sits among peer trials
592 643rd of 2000 higher than 1,358 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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