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

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

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Aliskiren Study of Safety and Efficacy in Senior Hypertensives

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