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 a diagnosis of essential hypertension who meet the following BP criteria at Visit 2: • Office msSBP = 140 mmHg and =65 years) 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 and clinically significant valvular heart disease. 6. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to Visit 1. 7. History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, coronary bypass surgery, myocardial infarction or any percutaneous coronary intervention (PCI). 8. Known Keith-Wagener grade III or IV hypertensive retinopathy. 9. 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. 10. Administration of any agent indicated for the treatment of hypertension after Visit 1 with the exception of those agents that require tapering down. 11. History of angioedema due to ACE-Is or ARBs administration. 12. Patients with Type 1 diabetes mellitus. 13. 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 and be on a stable dose of antidiabetic medications for at least 4 weeks prior to Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the prolonged efficacy of aliskiren 300 mg compared to telmisartan 80 mg on the change in 24-hour mean ambulatory systolic blood pressure (MASBP) from the end of the active treatment period to day 7 of the treatment interruption period.;Secondary Objective: Key secondary objectives are listed below. For full list, please refer to the protocol. 1. To estimate the prolonged efficacy of aliskiren 300 mg compared to telmisartan 80 mg on the change in 24-hour mean ambulatory diastolic blood pressure (MADBP) from the end of the active treatment period to day 7 of the treatment interruption period. 2. To estimate the prolonged efficacy of aliskiren 300 mg compared to telmisartan 80 mg on the change in 24-hour MASBP and MADBP from baseline to day 7 of the treatment interruption period. 3. To estimate the prolonged efficacy of aliskiren 300 mg compared to telmisartan 80 mg on the change in 24-hour MASBP and MADBP as measured in the last 4 hours from: a) baseline to the end of the active treatment period; b) baseline to day 7 of the treatment interruption period; c) from the end of active treatment to day 7 of the treatment interruption period (morning surge).;Primary end point(s): The primary efficacy variable is the change in 24-hour mean ambulatory systolic blood pressure (24-hour MASBP) over the 7 days treatment interruption period, that is, the change in 24-hour MASBP from end of active treatment to day 7 of treatment interruption. | — |
Countries
Germany, Hungary, Slovakia, Spain, United Kingdom
Outcome results
None listed