Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbi-mortality in Patients With Chronic Heart Failure (ATMOSPHERE)
Tracking Information
Start Date ICMJE | March 2009 |
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Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: February 27, 2009) | Delaying time to first occurrence of either cardiovascular death or heart failure hospitalization in patients with chronic heart failure [ Time Frame: 4 years ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00853658 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: February 27, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbi-mortality in Patients With Chronic Heart Failure |
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Official Title ICMJE | 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). |
Brief 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. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment |
Condition ICMJE | Chronic Heart Failure |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 7041 | ||||
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Completion Date | |||||
Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Australia, Belgium, Canada, China, Colombia, Costa Rica, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, India, Ireland, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Netherlands, Norway, Peru, Poland, Portugal, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Venezuela |
Administrative Information
NCT ID ICMJE | NCT00853658 |
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Responsible Party | External Affairs, Novartis Pharmaceuticals |
Study ID Numbers ICMJE | CSPP100F2301 |
Study Sponsor ICMJE | Novartis |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Novartis |
Source: http://clinicaltrials.gov/