CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 302 enrolled
Drug / intervention
LCZ696 (sacubitril/valsartan)drug
Likely dose
Not stated in 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/NCT02690974
NCT02690974Phase 4Completed
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Prospective, Multi-center, Open lAbel, Post-appRovAl Study AImed at Characterizing the Use of LCZ696 at 97 mg Sacubitril / 103 mg Valsartan Bid in Patients With HFrEF

Novartis Pharmaceuticals·interventional·Posted Feb 24, 2016·Updated Jun 7, 2019

In Brief

A Phase 4 clinical trial evaluating LCZ696 (sacubitril/valsartan) for Hearth Failure With Reduced Ejection Fraction (HFrEF). Completed, enrolled 302 participants across 32 sites.

Detailed Summary

The primary purpose of the study was to describe the tolerability of treatment with the optimal dose of LCZ696 (97 mg sacubitril / 103 mg valsartan bid), over six (6) months, in patients with heart failure with reduced ejection fraction (HFrEF) in Canada. The study was also to describe the overall tolerability, effectiveness and safety of LCZ696 for the management of HFrEF over 12 months of treatment, as well as describe the patterns of LCZ696 up and down dose titrations occurring during the management of patients with HFrEF.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHearth Failure With Reduced Ejection Fraction (HFrEF)
CountriesCanada
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 24, 2016
Enrollment StartMar 8, 2016
Primary CompletionJun 7, 2017
Study CompletionNov 29, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.4 years ago

Interventions

LCZ696 (sacubitril/valsartan)drug

All patients were treated with the LCZ696 (sacubitril and valsartan) tablets