cardiovacular disease, fonctional hypertension, MedDRA version: 12.1 Level: LLT Classification code 10020772 Term: Hypertension MedDRA version: 12.1 Level: LLT Classification code 10007648 Term: Cardiovascular disease, unspecified
Conditions
Interventions
Trade Name: Rasilez
Product Name: aliskiren
Product Code: SPP100
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: aliskiren
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study will enrol elderly people with SBP 130 to 159 mmHg (at Visit 1), and any one of the following (1, 2 or 3): 1. Men and women aged = 65 years if they have at least one of the following: (secondary prevention) Coronary heart disease a) Previous myocardial infarction or b) Stable angina or unstable angina with documented multi-vessel coronary artery disease > 50% stenosis in at least 2 major coronary arteries on coronary angiography, or positive stress test (ECG or nuclear perfusion scintogram), or c) Multi-vessel PCI, or d) Multi-vessel coronary artery bypass graft (CABG) surgery > 4 years prior to informed consent, or with recurrent angina or ischemia following surgery Stroke/TIA Previous documented stroke or documented TIA 50%) documented by angiography or non-invasive testing Diabetes mellitus Diabetes mellitus High-risk diabetics with evidence of end-organ damage 2. Men and women aged = 65 years with no history of CVD, and with at least 1 CV risk factor (primary prevention): a) History of dyslipidemia, defined as low-density lipoproteins (LDL) cholesterol > 3.5 mmol/L (135 mg/dL) or high-density lipoprotein (HDL) 5 b) History of current or recent smoking (regular tobacco use within 5 years) c) Abdominal adiposity defined as waist/hip ratio = 0.90 in women and = 0.95 in men d) History of dysglycemia defined as impaired fasting glucose (IFG – fasting plasma glucose 5.6 to 6.9 mmol/L [101 to 124 mg/dL]), or impaired glucose tolerance (IGT – fasting plasma glucose 30 ml/min/1.73m2 (Modification of diet in renal disease [MDRD] formula) and/or microalbuminurea/macroalbuminurea f) Clinical evidence of LVH 3. Men and women aged = 70 years if they do not have any of the above (primary prevention) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Current treatment with aliskiren, an ACE-inhibitor, an ARB or an aldosterone antagonist and unable to discontinue this therapy in those without clinical vascular disease. Individuals with CVD or type 2 diabetes and/or renal dysfunction may receive an ACE-inhibitor or an ARB, but not both 2. Contraindications to aliskiren, amlodipine or hydrochlorothiazide 3. Use of both thiazide diuretic and amlodipine or another calcium channel blocker Patients on only one of these two classes of drugs are eligible 4. Uncontrolled hypertension (systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg) 5. Symptomatic heart failure, requiring the use of loop diuretics 6. Hemodynamically significant primary valvular or outflow tract obstruction (e.g. aortic or mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve) 7. Constrictive pericarditis 8. Complex congenital heart disease 9. Acute stroke < 3 months or TIA = 7 days before informed consent 10. Acute coronary syndrome < 1 months before informed consent For a complete list of exclusion criteria, please refer to protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To determine whether treatment with an aliskiren-based regimen (in part combined with amlodipine or hydrochlorothiazide) compared to a non-aliskiren based regimen, both on top of non-study blood pressure lowering agents where applicable, reduces the risks of major cardiovascular events (composite of cardiovascular death, non-fatal MI, non-fatal stroke and significant heart failure) 2. To determine whether intensified therapy with aliskiren plus an additional BP lowering drug (amlodipine or hydrochlorothiazide) compared to placebo, both on top of non-study blood pressure lowering agents where applicable, reduces the risk of major cardiovascular events ;Secondary Objective: To determine whether treatment with an aliskiren-based regimen compared to non-aliskiren based regimen: 1. Prevents decline in the ability to perform everyday activities independently (key secondary objective) 2. Prevents decline in renal function 3. Reduces total mortality ;Primary end point(s): The primary end points are the composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and significant heart failure. | — |
Countries
Czech Republic, Germany, Hungary, Ireland, Netherlands, Spain, Sweden
Outcome results
None listed