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. Physically active outpatients, 50 years of age or older. 2. Patients with 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. Patients not confident in exercising or not able to exercise. 2. Absolute contraindication to exercise testing (see Appendix 1) 3. Hypertensive patients with msSBP = 180 mmHg and/or msDBP = 110 mmHg, at rest. 4. History or evidence of secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis, pheochromocytoma). 5. Current diagnosis of heart failure (NYHA Class II-IV). 6. Current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates). 7. Second or third degree heart block with or without a pacemaker. 8. Concurrent potentially life-threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to Visit 1. 9. Clinically significant valvular heart disease. 10. Long QT syndrome or QTc > 450 msec for males and > 470 msec for females at screening or baseline. 11. History of unilateral carotid artery stenosis more or equal to 70% or any endoarterectomy intervention within 6 months prior to screening visit. 12. History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, coronary bypass surgery, myocardial infarction or any percutaneous coronary intervention (PCI). 13. Known Keith-Wagener grade III or IV hypertensive retinopathy. 14. 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. 15. Patients taking antihypertensive medications requiring more than 28 days of tapering. 16. History of angioedema due to ACE-Is and ARBs administration. 17. History of Type 1 diabetes mellitus. 18. History of Type 2 diabetes mellitus unless patient is on stable antidiabetic medication regimen for at least 4 weeks prior to Visit 1. 19. 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 demonstrate that aliskiren 300 mg monotherapy exerts a greater blunting effect than valsartan 320 mg by assessing the rise in SBP at peak exercise (85% of the maximal predicted heart rate) and comparing the study baseline SBP to the end of the 48 hr dosing interval (after one missed dose), in mild to moderate hypertensive patients.;Secondary Objective: • To show that aliskiren 300 mg monotherapy exerts a greater blunting effect than valsartan 320 mg by assessing the rise in SBP at peak exercise (85% of the maximal predicted HR) and comparing the end of active treatment SBP to the end of the 48 hr dosing interval (after one missed dose), in mild to moderate hypertensive patients. • To evaluate the effect of aliskiren 300 mg monotherapy compared to valsartan 320 mg monotherapy on the rise of SBP during the treadmill exercise test assessed at each of the stages of the Bruce Protocol* comparing: 1) study baseline to the end of active treatment; 2) study baseline and the end of active treatment to the 48 hr dosing interval (after one missed dose). • To evaluate the overall safety and tolerability of aliskiren 300 mg compared to valsartan 320 mg monotherapies in patients during the treatment period, before and after exercise testing.;Primary end point(s): The primary variable will be change from baseline (Day 1) of SBP at peak vs rest (SBP at peak minus SBP at rest) during the treadmill test after a missed dose. | — |
Countries
Czech Republic, Hungary, United Kingdom
Outcome results
None listed