At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 140 enrolled
Drug / intervention
sacubitril/valsartan (LCZ696) +3 moredrug
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.
Multicenter, Randomized, Double-blind, Double Dummy, Parallel Group, Active-controlled 8-week Study and 8-week Open Label Extension to Evaluate the Effect of Initiation of Sacubitril/Valsartan on Objective Measures of Waking Activity and Sleep, as Health-related Quality of Life Functions in Subjects With Heart Failure and Reduced Ejection Fraction (AWAKE-HF).
In Brief
A Phase 4 clinical trial evaluating sacubitril/valsartan (LCZ696), enalapril, and 2 other interventions for Heart Failure, Reduced Ejection Fraction. Completed, enrolled 140 participants across 23 sites.
Detailed Summary
The purpose of this study was to investigate the effects of initiation of sacubitril/valsartan vs enalapril treatment on objective measures of both waking activity and sleep in subjects with heart failure with reduced ejection fraction.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Reduced Ejection Fraction
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartDec 2016
Primary CompletionMar 2018
TodayJul 2026
First PostedNov 22, 2016
Enrollment StartDec 16, 2016
Primary CompletionMar 19, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.6 years ago
Interventions
sacubitril/valsartan (LCZ696)drug
sacubitril/valsartan tablet taken orally.
enalaprildrug
Enalapril tablet taken orally.
matching placebo sacubitril/valsartan (LCZ696)drug
matching placebo sacubitril/valsartan tablet taken orally
matching placebo enalaprildrug
matching placebo enalapril tablet taken orally