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randOmized stUdy Using acceleromeTry to Compare Sacubitril/valsarTan and Enalapril in Patients With Heart Failure

NCT02900378 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 621

Last updated 2020-09-02

Study results available
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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

  • Chronic Heart Failure With Reduced Ejection Fraction

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-20
Primary Completion
2018-04-11
Completion
2018-04-11

Countries

  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Iceland
  • Ireland
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02900378 on ClinicalTrials.gov