NCT00894387

Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,639 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Decompensated Heart Failure
• Congestive Heart Failure

Interventions

Type	Name	Description
DRUG	Aliskiren	Aliskiren 150 mg and Aliskiren 300 mg
DRUG	Placebo	Placebo

Timeline

• Start date: 2009-05-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2009-05-07
• Last updated: 2013-11-07
• Results posted: 2013-10-10

Locations

308 sites across 24 countries: United States, Argentina, Belgium, Brazil, Canada, Colombia, Czechia, Finland, France, Germany, Hungary, India, Israel, Italy, Philippines, Poland, Romania, Russia, Singapore, Slovakia, Spain, Sweden, Taiwan, Turkey (Türkiye)