Hypertension
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatients 18 years of age and older. 2. 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. 3. Patients with a documented diagnosis of either type 1 or type 2 diabetes mellitus. Patients with type 2 diabetes must be on a stable dose of oral antidiabetic therapy medication for at least 4 weeks prior to Visit 1. For type 1 and type 2 diabetic patients requiring insulin therapy adjustment of the dose of insulin is permitted. 4. Patients with hypertension. Non-treated patients must have a MSDBP = 95 mmHg at any Visit 1 and Visit 2; treated patients must have a MSDBP = 85 mmHg at Visit 1 and MSDBP = 95 mmHg at Visit 2. 5. To be eligible for randomization into the double-blind treatment period at Visit 5 (Day 1) all 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: 1. Severe hypertension (grade 3 WHO classification; 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. Current diagnosis of heart failure (NYHA Class II-IV). 6. Transient ischemic cerebral attack during the 12 months prior to Visit 1. 7. History of myocardial infarction. 8. History of coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1. 9. Serum sodium less than the lower limit of normal, serum potassium 5.2 mEq/L at Visit 1, 3 and 4. 10. Current stable or unstable angina pectoris. 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. Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) > 9.0 % at Visit 1. 15. Any surgical or medical condition or treatment which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs including, but not limited to, any of the following: • History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection. • Currently active or previously active inflammatory bowel disease during the 12 months prior to Visit 1. • Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months prior to Visit 1. • Any history of pancreatic injury, pancreatitis, or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase. • Evidence of hepatic disease as determined by any one of the following: SGOT or SGPT values exceeding 3 x ULN at Visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt. • Evidence of renal impairment with an estimated creatinine clearance <50 mL/min according to Cockroft-Gault formula method. • Current treatment with cholestyramine or colestipol resins. 16. History of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the past five years. 17. History or evidence of drug or alcohol abuse within the last 12 months. 18. Pregnant or nursing women. 19. Known or suspected contraindications to the study medications, including history of allergy to ARBs or thiazide diuretics or other sulfonamide derivatives. 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 monitor would jeopardize the evaluation of efficacy or safety. 23. Participation in any investigational drug trial within one month of Visit 1. 24. Persons directly involved in the execution of this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the blood pressure lowering effects of aliskiren 300 mg when compared to placebo as add-on therapy to valsartan and HCTZ in patients with essential hypertension and diabetes mellitus, who have not adequately responded to valsartan 160 mg/HCTZ 25 mg alone, by testing the hypothesis of superior reduction in mean sitting diastolic blood pressure (MSDBP) from baseline to study end.;Secondary Objective: • Evaluate blood pressure lowering effects of aliskiren 300 mg when compared to placebo as add-on therapy to valsartan and HCTZ in patients with essential hypertension and diabetes mellitus, who have not adequately responded to valsartan 160 mg/HCTZ 25 mg alone, by testing the hypothesis of superior reduction in mean sitting systolic blood pressure (MSSBP) from baseline to study end. • Evaluate the blood pressure lowering effects of aliskiren 150 mg when compared to placebo as add-on therapy to valsartan and HCTZ in patients with essential hypertension and diabetes mellitus, who have not adequately responded to valsartan 160 mg/HCTZ 25 mg alone. • Compare the proportions of patients achieving a successful response (MSDBP of 10 mmHg from baseline) in each group at study end. • Compare the proportions of patients achieving a target blood pressure control of MSSBP of < 130 mmHg and MSDBP < 80 mmHg in each group at study end. ;Primary end point(s): The primary efficacy variable is change from baseline (Visit 5) in mean sitting diastolic blood pressure. The primary analysis endpoint will be the Visit 9 endpoint. | — |
Countries
Spain, Sweden
Outcome results
None listed