At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,639 enrolled
Drug / intervention
Aliskiren +1 moredrug
Likely dose
Aliskiren 150 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, Placebo-controlled Study to Evaluate the 6 Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality When Initiated Early After Hospitalization for Acute Decompensated Heart Failure
In Brief
A Phase 3 clinical trial evaluating Aliskiren and Placebo for Acute Decompensated Heart Failure and Congestive Heart Failure. Completed, enrolled 1,639 participants across 308 sites in 24 countries.
Detailed Summary
This study evaluated the effect of early initiation of aliskiren therapy, compared to standard therapy, in the reduction of cardiovascular death and heart failure re-hospitalization events within 6 months, in congestive heart failure (CHF) patients hospitalized for an episode of acute decompensated heart failure.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Belgium, Brazil, Canada, Colombia, Czechia, Finland, France, Germany, Hungary, India, Israel, Italy, Philippines, Poland, Romania, Russia, Singapore, Slovakia, Spain, Sweden, Taiwan, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2009
First PostedMay 2009
Primary CompletionAug 2012
TodayJul 2026
First PostedMay 7, 2009
Enrollment StartMay 1, 2009
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.2 years ago
Interventions
Aliskirendrug
Aliskiren 150 mg and Aliskiren 300 mg
Placebodrug
Placebo