Hypertension
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Outpatients 18 years of age and older. 2.Patients with essential hypertension. Patients must have a MSDBP >= 90 mmHg and = 95 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.History of severe hypertension (MSDBP >= 110 mmHg and/or MSSBP >= 180 mmHg) 2.History or evidence of a secondary form of hypertension 3.Known Keith-Wagener grade III or IV hypertensive retinopathy 4.History of hypertensive encephalopathy or cerebrovascular accident 5.Transient ischemic cerebral attack, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1 6.Current diagnosis of heart failure (NYHA Class II-IV) 7.History of myocardial infarction 8.Current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates) 9.Second or third degree heart block without a pacemaker 10.Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia 11.Clinically significant valvular heart disease 12.Type 1 or Type 2 diabetes mellitus with fasting glycosylated hemoglobin (HbA1c) > 9% or microalbuminuria or proteinuria at Visit 1 13.Serum sodium less than the lower limit of normal, serum potassium less than 3.5 mEq/L (corresponding to 3.5 mmol/L) or >= 5.5 mEq/L (corresponding to 5.5 mmol/L), or dehydration at Visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the long term efficacy of an aliskiren based treatment regimen (aliskiren 150 mg, 300 mg with optional add-on of amlodipine 5 mg/10 mg) to a HCTZ based treatment regimen (HCTZ 12.5 mg, 25 mg with optional add-on of amlodipine 5 mg/10 mg), in patients with essential hypertension by (i) testing the hypothesis of non-inferiority of the aliskiren regimen versus the HCTZ regimen on reduction of Mean Sitting Diastolic Blood Pressure (MSDBP) from baseline at 26 weeks, and (ii) the hypothesis of superiority for the aliskiren regimen versus the HCTZ regimen on reduction in MSDBP from baseline, if the hypothesis of non-inferiority is achieved;Secondary Objective: -Demonstrate non-inferiority of aliskiren regimen versus the HCTZ regimen on reduction of Mean Sitting Systolic Blood Pressure from baseline at 26 wks, and (ii)test superiority for aliskiren regimen versus the HCTZ regimen on reduction in MSSBP. -Demonstrate non-inferiority of aliskiren versus the HCTZ regimen on reduction of MSDBP and MSSBP at 52 wks from baseline and (ii) test superiority for aliskiren regimen versus HCTZ regimen on reduction in MSDBP and MSSBP. -Show non-inferiority of the aliskiren monotherapy versus HCTZ monotherapy on reduction of MSDBP and MSSBP at 12 wks from baseline and (ii) test for aliskiren versus HCTZ on reduction in MSDBP and MSSBP. -Confirm efficacy of aliskiren 300 mg compared to placebo by showing superiority on reduction in MSDBP from baseline after 6 wks of double-blind treatment. -Compare proportions of patients who respond to treatment or who are controlled with aliskiren based treatment regimen and HCTZ based treatment regimen ;Primary end point(s): The primary efficacy variable is the change from baseline (post baseline-baseline) in mean sitting diastolic blood pressure (MSDBP). The primary time point for efficacy will be at visit 11 (26 weeks) from baseline. | — |
Countries
Finland, Germany, Italy, Spain
Outcome results
None listed