Hypertension
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Outpatients 18 years of age and older. • Male or female patients are eligible. Female patients must be either post-menopausal for at least one year, surgically sterile, or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide or an intrauterine device. • Patients with uncomplicated severe hypertension. Patients must have a MSDBP = 85 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with any of the following physiological states or concomitant medical conditions prior to randomization will be excluded from participation in the study. • Patients who previously entered an aliskiren study and who qualified to be randomized or enrolled into active drug treatment period. • History or evidence of a secondary form of hypertension, including but not limited to any of the following: coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery sternosis, Cushing disease, pheochromocytoma, polycystic kidney disease. • Patients on combination antihypertensive therapy that includes more than 3 classes of antihypertensive medication. • Diabetic patients requiring insulin treatment. • Type 2 diabetics defined by fasting glycosylated hemoglobin (HbA1c) > 8% at Visit 1 • Known Keith-Wagener grade III or IV hypertensive retinopathy. • History of hypertensive encephalopathy or cerebrovascular event to include stroke or transient ischemic cerebral attack (TIA). • Previous or current diagnosis of heart failure of any class. • History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) at any time prior to Visit 1. • Any type of angina pectoris (treated or untreated). • Second or third degree heart block without a pacemaker. • Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia. • Clinically significant valvular heart disease. • Serum sodium less than the lower limit of normal, serum potassium 1.5 mg/dL (males) and > 1.3 mg/dL (females) at Visit 1, a history of dialysis, or a history of nephrotic syndrome. • Current treatment with cholestyramine and colestipol resins • History of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the past five years. • History or evidence of drug or alcohol abuse within the last 12 months. • Pregnant or nursing women. • Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study. • Known or suspected contraindications to the study medications, including history of allergy to angiotensin converting enzyme (ACE) inhibitor, thiazide diuretics, or other sulfonamide derived drugs. • History of gouty arthritis. • History of noncomplia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Evaluate the overall safety of a regimen of aliskiren 150 mg potentially titrated to 300 mg O.D. with potential addition of hydrochlorothiazide (HCTZ) compared to a regimen of lisinopril 20 mg potentially titrated to 40 mg O.D. with potential addition of HCTZ in patients with uncomplicated severe hypertension (MSDBP = 105 mmHg and < 120 mmHg);Secondary Objective: • Evaluate blood pressure lowering effects of a regimen of aliskiren 150 mg potentially titrated to 300 mg O.D. with potential addition of HCTZ compared to a regimen of lisinopril 20 mg potentially titrated to 40 mg O.D. with potential addition of HCTZ in patients with uncomplicated severe hypertension (MSDBP = 105 mmHg and < 120 mmHg). • Evaluate proportion of patients achieving a successful response (MSDBP < 90 mmHg or a reduction = 10 mmHg from baseline) for all treatment groups. ;Primary end point(s): The primary assessment for safety is the overall adverse events percentage. | — |
Countries
Hungary, Spain
Outcome results
None listed