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 one year, surgically sterile, or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide or an intrauterine device. •Patients with essential hypertension. •Non-treated patients must have a MSDBP = 95 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Patients who previously entered an aliskiren study and who qualified to be randomized or enrolled into the active drug treatment period. •Severe hypertension (MSDBP = 110 mmHg and/or MSSBP = 180 mmHg). •History or evidence of a secondary form of hypertension. •Known Keith-Wagener grade III or IV hypertensive retinopathy. •History of hypertensive encephalopathy or cerebrovascular accident. •Transient ischemic cerebral attack during the 12 months prior to Visit 1. •Current diagnosis of heart failure (NYHA Class II-IV). •History of myocardial infarction. •History of coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1. •Current angina pectoris requiring pharmacological therapy (other than patients on a stable dose of oral or topical nitrates). •Second or third degree heart block without a pacemaker. •Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia. •Clinically significant valvular heart disease or severe aortic stenosis. •Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) > 9% at Visit 1. •Serum sodium less than the lower limit of normal, serum potassium 1.7 mg/dl for women and serum creatinine > 2.0 mg/dl for men 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. •Known or suspected contraindications to the study medications, including history of allergy to amlodipine or dihydropyridine like calcium channel blockers. •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. •Participation in any investigational drug trial within one month of Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of the combination of aliskiren 150 mg and amlodipine 5 mg in patients with essential hypertension not fully responsive to amlodipine 5 mg by testing the hypothesis of superior reduction in MSDBP from baseline with the combination when compared to amlodipine 5 mg after 6 weeks of treatment;Secondary Objective: •Evaluate efficacy of combination of aliskiren 150 mg and amlodipine 5 mg in patients with essential hypertension not fully responsive to amlodipine 5 mg by testing of superior reduction in MSSBP from baseline with the combination when compared to amlodipine 5 mg after 6 weeks of treatment. •Compare safety and tolerability of combination of aliskiren 150 mg and amlodipine 5 mg to amlodipine 5 mg in patients with essential hypertension not fully responsive to amlodipine 5 mg. •Evaluate efficacy (change from baseline in MSDBP and MSSBP) of combination of aliskiren 150 mg and amlodipine 5 mg compared to amlodipine 10 mg in patients not fully responsive to amlodipine 5 mg. •Compare safety and tolerability of combination of aliskiren 150 mg and amlodipine 5 mg to amlodipine 10 mg in patients with essential hypertension not fully responsive to amlodipine 5 mg. ;Primary end point(s): The primary efficacy variable is change from baseline (Visit 4) in mean sitting diastolic blood pressure. The primary analysis timepoint will be the Visit 7 endpoint. | — |
Countries
Denmark, Germany, Slovakia
Outcome results
None listed