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Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction

NCT02226120 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1980

Last updated 2019-02-20

Study results available
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Summary

The purpose of this study was to collect safety and tolerability data on LCZ696 in eligible PARADIGM-HF patients who received open-label investigational drug. The parent PARADIGM-HF (NCT01035255) trial was terminated early due to compelling efficacy of LCZ696 in patients with heart failure with reduced ejection fraction (HFrEF) after the final pre-specified interim analysis in March 2014.

Conditions

  • Chronic Heart Failure With Reduced Ejection Fraction

Interventions

DRUG

LCZ696

Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-16
Primary Completion
2017-12-28
Completion
2017-12-28
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Guatemala
  • Hong Kong
  • Hungary
  • India
  • Israel
  • Italy
  • Latvia
  • Lithuania
  • Malaysia
  • Mexico
  • Netherlands
  • Panama
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Russia
  • Singapore
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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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 NCT02226120 on ClinicalTrials.gov