hypertension
Conditions
Interventions
Trade Name: Rasilez 150 mg Fimtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: aliskiren
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients must give written informed consent before any assessment is performed. 2. Outpatients =18 years of age. 3. Patients with a diagnosis of Stage II hypertension, defined as msSBP = 160 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: For full list, please refer to the protocol. 1. Severe hypertension defined as msSBP = 180 mmHg and/or msDBP = 110 mmHg. 2. History or evidence of secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis, pheocromocitoma). 3. Current diagnosis of heart failure (NYHA Class II-IV). 4. Current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates). 5. Second or third degree heart block without a pacemaker. 6. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to Visit 1. 7. Clinically significant valvular heart disease. 8. History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, coronary bypass surgery, myocardial infarction or any percutaneous coronary intervention (PCI). 9. Known Keith-Wagener grade III or IV hypertensive retinopathy. 10. In the month prior to Visit 1, patients on combination antihypertensive therapy that includes more than 2 classes of antihypertensive medications. Patients on combined antihypertensive medication that contain two classes of antihypertensive medications are considered to take two antihypertensive medications. 11. Administration of any agent indicated for the treatment of hypertension after Visit 1 with the exception of those agents that require tapering down. 12. History of angioedema due to ACE-Is or ARBs administration. 13. Patients with Type 1 diabetes mellitus. 14. Patients with Type 2 diabetes mellitus who are not well controlled based on investigator’s clinical judgment. Patients currently being treated for diabetes mellitus must have satisfactory metabolic control. Type 2 diabetic patients taking oral antidiabetic medication must be on a stable dose for at least 4 weeks prior to Visit 1. 15. Serum sodium less than the lower limit of normal, serum potassium < 3.5 mEq/L (corresponding to 3.5 mmol/L) or = 5.3 mEq/L (corresponding to 5.3 mmol/L), or dehydration at Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy variable is change from baseline (Week 0) in mean sitting systolic blood pressure (msSBP). The primary analysis time point will be the Week12 endpoint.;Main Objective: To compare the BP lowering effect of the combination of aliskiren / HCTZ 300/25 mg versus aliskiren 300 mg monotherapy in patients with Stage II hypertension by testing the hypothesis that the combination of aliskiren / HCTZ produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP) after 12 weeks of treatment.;Secondary Objective: For full list, please refer to the protocol. • To estimate the BP lowering effect of aliskiren / HCTZ (300/25 mg) combination vs aliskiren (300 mg) monotherapy on the change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment. • To estimate the BP lowering effect of aliskiren / HCTZ (300/25 mg) combination vs aliskiren (300 mg) monotherapy on the change from baseline in mean sitting diastolic blood pressure (msDBP) after 12 and 8 weeks of treatment. • To estimate the change from baseline in mean sitting systolic blood pressure (msSBP) after 12 and 8 weeks of treatment with aliskiren / HCTZ (300/25 mg) combination. • To estimate the change from baseline in mean sitting diastolic blood pressure (msDBP) after 12 and 8 weeks of treatment with aliskiren / HCTZ (300/25 mg) combination. • To estimate the change from baseline msSBP after 12 and 8 weeks of aliskiren (300 mg) monotherapy. | — |
Countries
Germany, Italy
Outcome results
None listed