NCT00853658

Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbidity-mortality in Patients With Chronic Heart Failure

A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of Both Aliskiren Monotherapy and Aliskiren/Enalapril Combination Therapy Compared to Enalapril Monotherapy, on Morbidity and Mortality in Patients With Chronic Heart Failure (NYHA Class II - IV). The Study is Also Known as Aliskiren Trial of Minimizing OutcomeS in Patients With HEart Failure (ATMOSPHERE).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7,064 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
DRUG	Enalapril	Enalapril 10 mg film-coated tablet and administered orally.
DRUG	Aliskiren	Aliskiren 150 mg titrated to 300 mg film-coated tablet and administered orally.

Timeline

• Start date: 2009-03-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2009-03-02
• Last updated: 2016-11-25
• Results posted: 2016-11-25

Locations

806 sites across 44 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Costa Rica, Czechia, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, Venezuela