Trials / Completed
CompletedNCT02900378
randOmized stUdy Using acceleromeTry to Compare Sacubitril/valsarTan and Enalapril in Patients With Heart Failure
A Multi-center, Prospective, Randomized, Double-blind Study to Assess the Impact of Sacubitril/Valsartan vs. Enalapril on Daily Physical Activity Using a Wrist Worn Actigraphy Device in Adult Chronic Heart Failure Patients
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 621 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this randomized, actively controlled, double-blind study with prospective data collection was to assess differences between sacubitril/valsartan versus enalapril in increasing exercise capacity and non-sedentary physical activity in HFrEF patients. Physical activity was assessed by the 6 minute walk test, and daily physical activity was continuously measured by means of a wrist-worn accelerometry device from 2 weeks before until 12 weeks after start of study therapy (sacubitril/valsartan or enalapril).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LCZ696 (Sacubitril/Valsartan) | LCZ696 (sacubitril/valsartan) was available in 24 mg/26 mg, 49 mg/51 and 97 mg/103 mg mg film-coated tablets |
| DRUG | Placebo of LCZ696 (Sacubitril/Valsartan) | Placebo of LCZ696 (sacubitril/valsartan) was available to match 24 mg/26 mg, 49 mg/51 and 97 mg/103 mg mg film-coated tablets |
| DRUG | Enalapril | Enalapril was available in 2.5 mg, 5 mg and 10 mg film-coated tablets |
| DRUG | Placebo of Enalapril | Placebo of Enalapril was available to match 2.5 mg, 5 mg and 10 mg film-coated tablets |
Timeline
- Start date
- 2016-12-20
- Primary completion
- 2018-04-11
- Completion
- 2018-04-11
- First posted
- 2016-09-14
- Last updated
- 2020-09-02
- Results posted
- 2019-09-16
Locations
119 sites across 19 countries: Belgium, Bulgaria, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, Ireland, Latvia, Lithuania, Netherlands, Norway, Poland, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT02900378. Inclusion in this directory is not an endorsement.