A twelve-week, randomized, double-blind, parallel group study to evaluate the prolonged efficacy and safety of aliskiren 300 mg compared to telmisartan 80 mg in mild to moderate hypertensive patients with 24-hour ambulatory blood pressure measurement after 1 week of treatment withdrawal.
- Conditions
- hypertension
- Registration Number
- EUCTR2008-007831-41-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 790
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 < 180 mmHg before application of ABPM;
• Twenty-four hour MASBP = 135 mmHg.
3. Male or female patients are eligible. Female patients must be either post-menopausal for at least one year, surgically sterile or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide or an intrauterine device. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
4. Patients who are eligible and 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 consent must give written informed consent before any assessment is performed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
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.
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