At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 498 enrolled
Drug / intervention
LCZ696drug
Likely dose
LCZ696 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-blind, Parallel Group Study to Assess the Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients Comparing Two Titration Regimens
In Brief
A Phase 2 clinical trial evaluating LCZ696 for Heart Failure With Reduced Ejection Fraction. Completed, enrolled 498 participants across 105 sites in 11 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Finland, Germany, Hungary, Italy, Puerto Rico, Slovakia, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 2013
Enrollment StartNov 2013
Primary CompletionAug 2014
TodayJul 2026
First PostedAug 14, 2013
Enrollment StartNov 1, 2013
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.9 years ago
Interventions
LCZ696drug
LCZ696 50 mg/100 mg/200 mg bid