Hypertension
Conditions
Interventions
Product Name: Aliskiren
Product Code: SPP100
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Aliskiren
Product Co
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who are hospitalized for ischemic chest discomfort at rest lasting at least 10 minutes and consistent with cardiac ischemia • Subjects who are clinically stable may not have any of the following spontaneous events for 24 hours prior to randomization: • Recurrent ischemia at rest • Symptomatic hypotension or hypotension defined as SBP 30 seconds) • Complete heart block • High grade second degree heart block (e.g. Mobitz Type II) • New onset atrial fibrillation 2. Final diagnosis of acute coronary syndrome that includes either: • unstable angina defined as chest discomfort with 1) transient ST segment deviation at least 0.5 mm in at least two contiguous leads or, 2) documented coronary artery disease as defined as prior MI or evidence of a coronary stenosis at least 50% or • acute myocardial infarction (MI) defined as elevated concentrations of cardiac troponin I or T, or CK-MB 3. Elevated concentrations of natriuretic peptide (local determination) 3-10 days (72 -240 hours) after admission for their index event • NT-proBNP level > 400 pg/ml or BNP level > 80 pg/ml Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: For full list, refer to protocol 1. Known or suspected contraindications, including history of allergy or hypersensitivity to ARBs, renin antagonists, or to drugs with similar chemical structures. 2. Presence of clinically overt heart failure defined as the presence of rales 1/3 up both lung fields, chest radiography showing at least moderate pulmonary venous congestion, or the presence of a third heart sound. 3. Known evidence of left ventricular systolic dysfunction (an ejection fraction <= 40% as determined by echocardiography, nuclear imaging or ventriculography). 4. CABG less than 3 months before randomization. 5. PCI less than 24 hours before randomization. 6. Planned revascularization within 3 months after randomization. 7. New ACEI, ARBs, or aldosterone inhibitor treatment given for more than 24 hours as part of the index hospitalization. 8. An increase in a chronic dose of ACEI, ARBs, or aldosterone inhibitor treatment given for more than 24 hours as part of the index hospitalization. 9. Patients on chronic ACEI or ARB therapy for whom therapy with an ACEI or ARB is clinically required with no reasonable alternative therapy available 10. Estimated creatinine clearance < 45 ml/min (MDRD Calculation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Determine whether aliskiren reduces the levels of NT-proBNP from baseline to week 8 as compared to placebo. • Determine whether valsartan reduces the levels of NT-proBNP from baseline to week 8 as compared to placebo. • Determine whether the combination of aliskiren and valsartan reduces the levels of NT-proBNP from baseline to week 8 as compared to each individual monotherapy and placebo. ;Primary end point(s): The primary variable will be the relative reduction to baseline in NT-proBNP, expressed as a (logarithmised) ratio of at week 8 divided by baseline levels. The NT-proBNP values at Visit 2 from the central laboratory will be used as baseline values;Secondary Objective: For Full list, refer to protocol • Determine whether monotherapy with aliskiren or valsartan reduces the levels of NT-proBNP from baseline to week 4 to as compared to placebo. • Explore whether aliskiren or valsartan reduces the rate of adverse cardiac events (death, recurrent myocardial infarction, or hospitalization for congestive heart failure) at week 8 as compared to placebo. • Explore whether the combination of aliskiren or valsartan reduces the rate of adverse cardiac events (death, recurrent myocardial infarction, or hospitalization for congestive heart failure) at week 8 as compared to each individual monotherapy and placebo. | — |
Countries
Czech Republic, Germany, Hungary, Netherlands, Sweden
Outcome results
None listed