Extension 1 to Protocol A 2 year extension to a 36-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren on the prevention of left ventricular remodeling in high risk post-acute myocardial infarction patients when added to optimized standard therapy
Phase 3
Completed
- Conditions
- 10028593heart attackMyocardial infarct
- Registration Number
- NL-OMON32303
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
See protocol for complete criteria (page 5)
Completed the CSPP100A2340 / ASPIRE study through visit 10 while on double-blind study drug.
Exclusion Criteria
See protocol for complete criteria (page 5)
- NYHA class IV Congestive Heart Failure at Visit 1 (CSPP100A2340 Core Study Visit 10).
- Symptomatic hypotension, or reported systolic BP < 90 mmHg within the 24 hours prior to Visit 1.
- eGFR < 30 ml/min/1.73m2 using the MDRD formula at Visit 1.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this Extension study is to provide additional<br /><br>long-term safety data as a post marketing commitment to the EMEA. The<br /><br>assessment of safety will be based primarily on the frequency of adverse<br /><br>events, laboratory abnormalities, and serious adverse events. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The efficacy variables for this Extension study are:<br /><br>* the change from baseline to the post-baseline measurement in LVESV as<br /><br>assessed by echocardiography<br /><br>* the change from baseline to the post-baseline measurement in LVEDV as<br /><br>assessed by echocardiography<br /><br>* the change from baseline to the post-baseline measurement in LVEF as<br /><br>assessed by echocardiography</p><br>