Health Condition 1: null- Cardiovascular Events
Conditions
Interventions
Intervention1: Aliskiren
: Orally active nonpeptidic renin inhibitor.
Each patient will take study medication by mouth (p.o.) with water per day throughout
the
run-in and the randomized phases.
Stud
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Systolic blood pressure 130 - 159 mmHg with any one of the following (1, 2 or 3): 1. Men and women aged greater than equal to 65 years if they have at least one of the following: (secondary prevention) Coronary heart disease o Previous myocardial infarction or o Stable angina or unstable angina with documented multi-vessel coronary artery disease, l 50 percentage stenosis in at least 2 major coronary arteries on coronary angiography, or positive stress test (ECG or nuclear perfusion scintogram), or o Multi-vessel PCI, or o Multi-vessel CABG surgery greater than4 years prior to informed consent, or with recurrent angina or ischemia following surgery Stroke/TIA Previous documented stroke or documented TIA less than 1 year before informed consent Peripheral artery disease o Previous limb bypass surgery or percutaneous transluminal angioplasty, or o Previous limb or foot amputation, or o History of intermittent claudication, with an ankle:arm BP ratio less than equal to 0.80 on at least one side, or significant peripheral artery stenosis (greater than 50 percentage) documented by angiography or non-invasive testing Diabetes mellitus High-risk diabetics with evidence of end-organ damage 2. Men and women aged greater than equal to 65 years with no history of CVD, and with at least 1 CV risk factor (primary prevention): o History of dyslipidemia, defined as LDL cholesterol greater than 3.5 mmol per L (135 mg per dL) or HDL less than1.3 mmol per L (50 mg per dL) in women or less than 1.0 mmol per L (39 mg per dL) in men or total cholesterol per HDL ratio greater than 5 o History of current or recent smoking (regular tobacco use within 5 years) o Abdominal adiposity defined as waist per hip ratio greater than equal to 0.90 in women and greater than equal to 0.95 in men o History of dysglycemia defined as impaired fasting glucose (IFG - fasting plasma glucose 5.6 to 6.9 mmol per L [101 to 124 mg per dL]), or impaired glucose tolerance (IGT - fasting plasma glucose less than7 mmol per L [126 mg per dL] but 2 hour glucose 7.8 to 11.0 mmol per L [140 to 198 mg per dL]) or type 2 diabetes o Renal dysfunction: eGFR less than 60 ml per min per 1.73m2 but greater than 30 ml per min per 1.73m2 (MDRD formula) and/or micro albuminurea per macro albuminurea o Clinical evidence of left ventricular hypertrophy 3. Men and women aged greater than equal to 70 years if they do not have any of the above (primary prevention)
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 per or renal dysfunction may receive an ACE-inhibitor or an ARB, but not both, contraindications to aliskiren, amlodipine or hydrochlorothiazide. 2. Use of both thiazide diuretic and amlodipine or another calcium channel blocker Patients on only one of these two classes of drugs are eligible 3. Uncontrolled hypertension (systolic blood pressure greater than equal to160 mmHg and/or diastolic blood pressure greater than equal to 100 mmHg) 4. Symptomatic heart failure, requiring the use of loop diuretics 5. Hemodynamically significant primary valvular or outflow tract obstruction (e.g. aortic or mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve). Constrictive pericarditis. Complex congenital heart disease. 6. Acute stroke less than 3 months or TIA less than equal to 7 days before informed consent, acute coronary syndrome less than 1 months before informed consent 7. Planned cardiac surgery or angioplasty less than 3 months after informed consent or having had the procedure less than 3 months before informed consent 8. Severe renal impairment eGFR less than equal to 30 ml per minper 1.73m2 (MDRD formula); known renal artery stenosis ; serum potassium greater than equal to 5.3 mmol per L 9. Chronic liver disease (i.e. cirrhosis, esophageal varices, portocaval shunt or persistent hepatitis) or abnormal liver function, i.e., alanine transaminase (ALT) or AST greater than 3x upper limit of normal (ULN) 10. Concurrent treatment with cyclosporine or quinidine; chronic use of non-steroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX 2) inhibitors in patients with eGFR less than 60 ml per min per 1.73m2 (MDRD formula) 11. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years regardless of whether there is evidence of local recurrence or metastases 12. Other serious condition(s) likely to interfere with study participation or with the ability to complete the study. Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in risk of major cardiovascular events (composite of CV death, non-fatal MI, non-fatal stroke and significant heart failure) Time Frame: 6 yearsTimepoint: Time Frame: 6 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Prevention of decline in renal functionTimepoint: 6 years;Prevention of decline in the ability to perform everyday activities independentlyTimepoint: 6 years;Reduction of total mortalityTimepoint: 6 years | — |
Countries
Argentina, Brazil, Canada, Chile, Colombia, Czech Republic, Germany, Hungary, India, Ireland, Malaysia, Netherlands, Philippines, Russian Federation, South Africa, Spain, Sweden, Turkey, Ukraine, United States of America
Contacts
Public ContactMurugananthan K
Novartis Heathcare Pvt Ltd
Outcome results
None listed