Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure
Tracking Information
Start Date ICMJE | May 2009 |
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Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: May 5, 2009) | Delay time of first occurrence of either cardiovascular death or heart failure re-hospitalization within 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00894387 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: May 5, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure |
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Official Title ICMJE | 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 |
Brief Summary | This study will evaluate 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. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
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Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 1782 | ||||
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Completion Date | |||||
Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply. | ||||
Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Belgium, Brazil, Canada, Colombia, Czech Republic, Finland, France, Germany, Hungary, India, Israel, Italy, Philippines, Poland, Romania, Russian Federation, Singapore, Slovakia, Spain, Sweden, Taiwan, Turkey |
Administrative Information
NCT ID ICMJE | NCT00894387 | ||||
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Responsible Party | External Affairs, Novartis | ||||
Study ID Numbers ICMJE | CSPP100A2368 | ||||
Study Sponsor ICMJE | Novartis | ||||
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Investigators ICMJE |
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Information Provided By | Novartis |
Source: http://clinicaltrials.gov/