Hypertension
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female outpatients 18 years of age and older. 2. Patients with essential hypertension (MSDBP ? 95 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who previously entered an aliskiren study and who qualified to be randomized or enrolled into the active drug treatment period. 2. Severe hypertension (MSDBP = 110 mmHg and/or MSSBP = 180 mmHg) 3. History or evidence of a secondary form of hypertension 4. Known Keith-Wagener grade III or IV hypertensive retinopathy. 5. History of hypertensive encephalopathy or cerebrovascular accident 6. Transient ischemic cerebral attack during the 12 months prior to Visit 1. 7. Previous and current diagnosis of heart failure (NYHA Class II-IV). 8. History of myocardial infarction. 9. Coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1. 10. Current angina pectoris requiring pharmacological therapy (other than patients on a stable dose of oral or topical nitrates) 11. Second or third degree heart block without a pacemaker. 12. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia. 13. Clinically significant valvular heart disease. 14. Patients with current diagnosis of diabetes (Type 1 or 2) 15. Serum sodium less than the lower limit of normal, serum potassium 1.7 mg/dl (corresponding to 150 µmol/L) for women and serum creatinine >2.0 mg/dl (corresponding to 177 µmol/L) for men at Visit 1, a history of dialysis, or a history of nephrotic syndrome. • Current treatment with cholestyramine and colestipol resins. 17. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. 18. History or evidence of drug or alcohol abuse within the last 12 months. 19. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml). 20. 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. 21. History of noncompliance to medical regimens or unwillingness to comply with the study protocol. 22. Any condition that in the opinion of the investigator or the Novartis medical mon
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the blood pressure lowering effects of the combination of aliskiren 300 mg and HCTZ 25 mg in obese patients with essential hypertension inadequately treated with HCTZ 25 mg by testing the hypothesis of superior reduction from baseline in mean sitting diastolic blood pressure (MSDBP) with aliskiren-HCTZ treatment compared to HCTZ alone at Week 8.;Secondary Objective: • Evaluate blood pressure lowering effects of combination of aliskiren 300 mg and HCTZ 25mg in obese patients with essential hypertension inadequately treated with HCTZ 25 mg by testing superior reduction from baseline in mean sitting systolic blood pressure (MSSBP) with aliskiren-HCTZ treatment compared to HCTZ alone at Week 8. • Evaluate blood pressure lowering effects of combination of aliskiren 300 mg and HCTZ 25mg in obese patients with essential hypertension inadequately treated with HCTZ 25 mg by testing superior reduction from baseline in MSSBP and MSDBP with aliskiren-HCTZ treatment compared to HCTZ alone at the end of the study. • Compare changes in MSDBP and MSSBP of aliskiren with HCTZ combination to irbesartan-HCTZ combination and to amlodipine-HCTZ combination treatments from baseline to Week 4, to Week 8 and to the end of study. • Evaluate proportion of patients achieving a successful response in all treatment groups at Week 8 and at the end of the study. ;Primary end point(s): The primary efficacy variable is change from baseline in MSDBP and the primary analysis time point is week 8. | — |
Countries
Belgium, Germany, Spain
Outcome results
None listed