Aliskiren Study of Safety and Efficacy in Senior Hypertensives
Status: | Not yet recruiting |
---|---|
Conditions: | High Blood Pressure (Hypertension) |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 65 - Any |
Updated: | 3/16/2015 |
Start Date: | April 2015 |
End Date: | April 2018 |
Contact: | Novartis Pharmaceuticals |
Phone: | 1-888-669-6682 |
A Randomized, Double-blind, Parallel Group, Active-controlled Study to Compare the Systolic Blood Pressure Lowering Efficacy of Aliskiren, Ramipril and a Combination of Aliskiren and Amlodipine, With an Initial 8-week Evaluation, Followed by a 2-3 Year Follow-up to Compare Long-term Safety of an Aliskiren-based Regimen to a Ramipril-based Regimen in Hypertensive Patients ≥ 65 Years of Age
This study is designed to compare the blood pressure lowering efficacy of aliskiren, a
combination of aliskiren plus amlodipine, and ramipril in elderly patients with mild to
moderate hypertension. It will also compare the long-term safety of an aliskiren-based
regimen to a ramipril-based regimen
combination of aliskiren plus amlodipine, and ramipril in elderly patients with mild to
moderate hypertension. It will also compare the long-term safety of an aliskiren-based
regimen to a ramipril-based regimen
Inclusion Criteria:
- Patients ≥ 65 years of age with a clinical diagnosis of essential hypertension at
Visit 1.
- Mean sitting SBP (MSSBP) ≥ 140 mmHg and < 180 mmHg at Visit 2/Visit 201 and Visit 3.
- Absolute MSSBP difference ≤ 20 mmHg between Visit 3 and the Visit immediately prior
Exclusion Criteria:
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical
classes.
- Severe hypertension (MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg) at Visit 1, Visit 2, Visit
201 or Visit 3 or during patient self measured blood pressure (SMBP) monitoring in
the pre-randomization period confirmed by office measurement.
- Current treatment with any blocker of the renin angiotensin aldosterone system (RAAS)
(aliskiren, ACE inhibitor, angiotensin receptor blocker or an aldosterone antagonist)
and unable to discontinue this therapy.
- Concurrent use of any anti-hypertensive medications except a stable dose of 3 months
prior to Visit 1 of alpha adrenergic blockers for benign prostatic hypertrophy (e.g.,
tamsulosin [Flomax®] for benign prostatic hypertrophy), beta blockers for angina, or
beta blocker ophthalmic preparations.
- Contraindications to aliskiren, ramipril, amlodipine, or hydrochlorothiazide. Other
protocol defined inclusion/exclusion criteria apply
We found this trial at
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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