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Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients

NCT01922089 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 498

Last updated 2015-10-15

Study results available
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Summary

The purpose of this study is to assess the safety and tolerability of initiating LCZ696 in heart failure patients with reduced ejection fraction (HF-rEF) using conservative (reaching target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration regimens.

Conditions

  • Heart Failure With Reduced Ejection Fraction

Interventions

DRUG

LCZ696

LCZ696 50 mg/100 mg/200 mg bid

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States
  • Bulgaria
  • Finland
  • Germany
  • Hungary
  • Italy
  • Puerto Rico
  • Slovakia
  • Spain
  • Turkey (Türkiye)
  • 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 NCT01922089 on ClinicalTrials.gov