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Описание
Краткое названиеA Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People
Полное названиеA Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People
СпонсорNovartis
Industry
ИсточникNovartis
Под контролемArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: Ministry of Health
Canada: Health Canada
Chile: Ministry of Health
China: State Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
Ireland: Ministry of Health
Israel: Ministry of Health
Italy: National Institute of Health
Malaysia: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Philippines: Bureau of Food and Drugs (BFAD)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health and Social Development of the Russian Federation
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Turkey: Ministry of Health
United States: Food and Drug Administration
Краткое описаниеThis study will provide new information regarding the role of aliskiren (with or without
additional therapy with a diuretic or a CCB) in elderly individuals (?‰? 65 years) with SBP
130 to 159 mmHg, in preventing major CV events and on global measures of physical, executive
and cognitive function.
СостояниеНабор не начат
Дата началаDecember 2010
ФазаPhase 3
Вид исследованияAllocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Набор0
КритерииInclusion Criteria:

Systolic blood pressure 130 - 159 mmHg with 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

- Previous myocardial infarction or

- 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

- Multi-vessel PCI, or

- Multi-vessel CABG surgery > 4 years prior to informed consent, or with recurrent
angina or ischemia following surgery Stroke/TIA Previous documented stroke or
documented TIA < 1 year before informed consent Peripheral artery disease

- Previous limb bypass surgery or percutaneous transluminal angioplasty, or

- Previous limb or foot amputation, or

- History of intermittent claudication, with an ankle:arm BP ratio ?‰¤ 0.80 on at
least one side, or significant peripheral artery stenosis (> 50%) documented by
angiography or non-invasive testing 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):

- History of dyslipidemia, defined as LDL cholesterol > 3.5 mmol/L (135 mg/dL) or
HDL< 1.3 mmol/L (50 mg/dL) in women or < 1.0 mmol/L (39 mg/dL) in men or total
cholesterol/HDL ratio > 5

- History of current or recent smoking (regular tobacco use within 5 years)

- Abdominal adiposity defined as waist/hip ratio ?‰? 0.90 in women and ?‰? 0.95 in men

- 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 < 7 mmol/L [126 mg/dL] but 2 hour glucose 7.8 to
11.0 mmol/L [140 to 198 mg/dL]) or type 2 diabetes

- Renal dysfunction: eGFR< 60 ml/min/1.73m2 but > 30 ml/min/1.73m2 (MDRD formula)
and/or microalbuminurea/macroalbuminurea

- Clinical evidence of left ventricular hypertrophy

3. Men and women aged ?‰? 70 years if they do not have any of the above (primary
prevention)

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, 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 ?‰? 160 mmHg and/or diastolic blood
pressure ?‰? 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 < 3 months or TIA ?‰¤ 7 days before informed consent, acute coronary
syndrome < 1 months before informed consent

7. Planned cardiac surgery or angioplasty < 3 months after informed consent or having
had the procedure < 3 months before informed consent

8. Severe renal impairment eGFR ?‰¤ 30 ml/min/1.73m2 (MDRD formula); known renal artery
stenosis ; serum potassium ?‰? 5.3 mmol/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 > 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 < 60 ml/min/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
ПолBoth
Минимальный возраст65 Years
Максимальный возрастN/A
УсловиеCardiovascular Events
Применяемое лечение
DrugAliskiren and Amlodipine or HCTZ
DrugAliskiren
DrugAmlodipine or HCTZ
DrugPlacebo
Контакты и расположение
Kyiv Investigative Site
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