patients with both hypertension and diabetes mellitus
Conditions
Sponsors
Novartis Pharma CH
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 or an intrauterine device. 3. Patients with a documented diagnosis of Type 1 or Type 2 diabetes mellitus. Patients currently being treated for diabetes mellitus must be on a stable dose of anti-diabetic medication for at least 4 weeks prior to Visit 1. 4. Patients with essential hypertension. Patients must have a MSDBP = 90 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 (grade 3 WHO classification; 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. Current diagnosis of heart failure (NYHA Class II-IV). 7. Transient ischemic cerebral attack during the 12 months prior to Visit 1. 8. History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 6 months prior to Visit 1. 9. Serum sodium less than the lower limit of normal, serum potassium 1.5 x ULN at Visit 1, a history of dialysis, or a history of nephrotic syndrome. - Current treatment with cholestyramine or colestipol resins. 15. History of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the past five years. 16. History or evidence of drug or alcohol abuse within the last 12 months. 17. Pregnant or nursing women. 18. 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. 19. Known or suspected contraindications to the study medications, including history of allergy to ACE-Inhibitors. 20. History of noncompliance to medical regimens or unwillingness to comply with the study protocol. 21. Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety. 22. Participation in any investigational drug trial within one month of Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are to: • Demonstrate the efficacy of the combination of aliskiren 300 mg and ramipril 10 mg in patients with hypertension and diabetes mellitus by testing the hypothesis of superior reduction in MSDBP from baseline when compared to the component monotherapies. • Compare the efficacy of aliskiren 300 mg to ramipril 10 mg in patients with hypertension and diabetes mellitus by testing the hypothesis that aliskiren monotherapy is non-inferior (or superior) to ramipril 10 mg in MSDBP reduction from baseline. ;Secondary Objective: • Evaluate the efficacy of the combination of aliskiren 150 mg and ramipril 5 mg compared to the component monotherapies on MSDBP reduction from baseline to 4 weeks of treatment in patients with hypertension and diabetes mellitus. • Evaluate the efficacy of aliskiren 150 mg compared to ramipril 5 mg on MSDBP reduction from baseline to 4 weeks of treatment in patients with hypertension and diabetes mellitus. • Evaluate the safety and tolerability of aliskiren 150 mg and 300 mg, given alone and in combination with ramipril 5 mg and 10 mg, in patients with hypertension and diabetes mellitus. ;Primary end point(s): The primary efficacy variable is change from baseline (Visit 3) in mean sitting diastolic blood pressure. The primary analysis time-point will be the Week-8 endpoint. For each patient, the last post-baseline measurement during the double-blind period will be carried forward to Week 8 as the Week-8 endpoint measurement for the variable to be analyzed | — |
Countries
Denmark, Germany, Italy, Spain, Sweden
Outcome results
None listed