Trials / Completed
CompletedNCT02970669
Study on the Effects of Sacubitril/Valsartan on Physical Activity and Sleep in Heart Failure With Reduced Ejection Fraction Patients.
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).
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 140 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sacubitril/valsartan (LCZ696) | sacubitril/valsartan tablet taken orally. |
| DRUG | enalapril | Enalapril tablet taken orally. |
| DRUG | matching placebo sacubitril/valsartan (LCZ696) | matching placebo sacubitril/valsartan tablet taken orally |
| DRUG | matching placebo enalapril | matching placebo enalapril tablet taken orally |
Timeline
- Start date
- 2016-12-16
- Primary completion
- 2018-03-19
- Completion
- 2018-03-19
- First posted
- 2016-11-22
- Last updated
- 2021-10-07
- Results posted
- 2019-04-08
Locations
23 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02970669. Inclusion in this directory is not an endorsement.