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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000198

Enrollment

500

Registered

2009-06-10

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Myocardial Infarction

Interventions

Intervention1: Aliskiren: Aliskiren 300 mg qd (tablet), oral, for 2 years Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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).

Design outcomes

Primary

Measure	Time frame
? Adverse events at each visitTimepoint: Time Frame: 24 months	—

Secondary

Measure	Time frame
? 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	—

Countries

Algeria, Belgium, Canada, Colombia, Czech Republic, Denmark, Germany, Hungary, India, Ireland, Italy, Netherlands, Norway, Poland, Russian Federation, Slovakia, Spain, Sweden, Turkey, United Kingdom, Venezuela (Bolivarian Republic of)

Contacts

Public ContactMurugananthan K

Novartis Healthcare Private Limited,

murugananthan.k@novartis.com02224958545

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026