Extension 1 to Protocol CSPP100A2340: 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
- Conditions
- Health Condition 1: null- Myocardial Infarction
- Registration Number
- CTRI/2009/091/000198
- Lead Sponsor
- Medical Dept Sandoz House Shiv Sagar Estate Dr Annie Besant Road Worli Mumbai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
1. Patients that complete the CSPP100A2340 â??Coreâ?? study through Visit 10, while on
double-blind study drug.
2. Patients who are able to participate in the study, and who consent to do so after the
purpose and nature of the study has been clearly explained to them (written informed
consent).
1. NYHA class IV Congestive Heart Failure at Visit 1 (CSPP100A2340 â??Coreâ?? Study Visit
10).
2. Symptomatic hypotension, or reported systolic BP 90 mmHg within the 24 hours prior
to Visit 1 (CSPP100A2340 â??Coreâ?? Study Visit 10).
3. Known Estimated Glomerular Filtration Rate (eGFR) 30 ml/min/1.73m2 using the
MDRD formula at Visit 1 (CSPP100A2340 â??Coreâ?? Study Visit 10).
4. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female
after conception and until the termination of gestation, confirmed by a positive hCG
laboratory test ( 5 mIU/ml).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ?Adverse events at each visitTimepoint: Time Frame: 24 months
- Secondary Outcome Measures
Name Time Method ?Echocardiography (left ventricular end systolic volume, left ventricular end diastolic volume, left ventricular ejection fraction) at 12 monthsTimepoint: Time Frame: 24 months;ECG at 12 and 24 monthsTimepoint: Time Frame: 24 months;Laboratory evaluations at each visitTimepoint: Time Frame: 24 months;Vital signs (blood pressure, heart rate) at each visitTimepoint: Time Frame: 24 months