CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,822 enrolled
Drug / intervention
LCZ696 +1 moredrug
Likely dose
LCZ696 50mgfrom 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/NCT01920711
NCT01920711Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients (NYHA Class II-IV) With Preserved Ejection Fraction (PARAGON-HF)

Novartis Pharmaceuticals·interventional·Posted Aug 12, 2013·Updated Sep 29, 2020

In Brief

A Phase 3 clinical trial evaluating LCZ696 and Valsartan for Heart Failure With Preserved Ejection Fraction. Completed, enrolled 4,822 participants across 715 sites in 43 countries.

Detailed Summary

The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure With Preserved Ejection Fraction
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 12, 2013
Enrollment StartJul 18, 2014
Primary CompletionJun 7, 2019
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 12.9 years ago

Interventions

LCZ696drug

LCZ696 50mg, 100mg and 200 mg dosage strengths will be available for dose adjustments.

Valsartandrug

Valsartan 40mg, 80mg and 160mg dosage strengths will be available for dose adjustments.