An eight-week, randomized, double-blind, parallel-group, pilot study to evaluate the efficacy and safety of aliskiren 300 mg in comparison with valsartan 320 mg in patients with mild to moderate hypertension during exercise after a missed dose.
- Conditions
- hypertensionMedDRA version: 9.1Level: LLTClassification code 10015488Term: Essential hypertension
- Registration Number
- EUCTR2008-005500-10-CZ
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
1. Physically active outpatients, 50 years of age or older.
2. Patients with msSBP = 140 mmHg and < 180 mmHg measured at rest at Visit 2.
3. 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, barrier method with spermicidal or an intrauterine device.
4. Patients who are eligible, able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
5. Patients being able to exercise and to reach 85% of their predicted heart rate during an exercise test on a treadmill according to the Bruce Protocol at Visit 2 .
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method