hypertension MedDRA version: 9.1 Level: LLT Classification code 10015488 Term: Essential hypertension
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are eligible and able to participate in the study and who provide written informed consent to do so after the purpose and nature of investigation has been clearly explained to them. 2. Male or female outpatients, 18 years of age or older. 3. Patients with a diagnosis of mild to moderate hypertension at visit 1 (defined as msSBP = 140 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 at any visit. 2. History or evidence of secondary hypertension of any etiology (e.g., untreated renal artery stenosis, pheochromocytoma). 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. History of angioedema due to ACEI and/or ARB administration. 11. For patients with mild hypertension, an antihypertensive therapy regimen that includes more than one class of medication prior to Visit 1. (It means that patients on a fixed dose combination antihypertensive therapy that include two or more classes are considered to take two or more antihypertensive medications and therefore cannot be enrolled in the study) 12. For patients with moderate hypertension, the antihypertensive therapy that includes more than two classes of medication prior to Visit 1. 13. Patients with Type 1 diabetes mellitus. 14. Patients with Type 2 diabetes mellitus who are not well controlled based on investigator’s judgment. Patients currently being treated for diabetes mellitus must have satisfactory metabolic control. Type 2 diabetic patients taking oral antidiabetics must be on 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 |
|---|---|
| Main Objective: To assess in patients with uncomplicated mild to moderate hypertension (defined as msSBP = 140 mmHg and < 180 mmHg and/or msDBP = 90 and <110 mmHg) the percentage of patients reaching BP target irrespective of whether this target is reached with aliskiren monotherapy or with a combination treatment regimen. (For non diabetic patients the BP target is defined as msSBP < 140 mmHg and msDBP < 90 mmHg and for diabetic patients the BP target is msSBP < 130 mmHg and msDBP < 80 mmHg).;Secondary Objective: Key secondary objectives are listed below. For full list, please refer to the protocol. • To assess in mild hypertensive patients (defined as: 140 = msSBP < 160 mmHg and 90 = msDBP < 100 mmHg) and in moderate hypertensive patients (defined as: 160 = msSBP < 180 mmHg and 100 = msDBP < 110 mmHg), the percentage of patients reaching BP target, irrespective of whether this target is reached with aliskiren monotherapy or with a combination treatment regimen. • To assess in the non-diabetic patients and in the diabetic patients, the percentage of patients reaching BP target, irrespective of whether this target is reached with aliskiren monotherapy or with a combination treatment regimen. • To assess in the mild to moderate hypertensive patients the changes in msSBP and msDBP from baseline to target BP irrespective of whether this target is reached with aliskiren monotherapy or with a combination treatment regimen.;Primary end point(s): The primary efficacy variable will be the proportion of patients who reached the target BP. The control rates of patients who reached the target per visit are estimated by 1-survivor function S(t) (the BP target is msSBP/msDBP < 130/80 mmHg for diabetics and msSBP/msDBP < 140/90 mmHg for non-diabetics). | — |
Countries
France, Hungary
Outcome results
None listed