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

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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
We found this trial at
36
sites
Plano, Texas 75024
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Belzoni, Mississippi 39038
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Binghamton, New York 13901
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Birmingham, Alabama 35209
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Birmingham, AL
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Chandler, Arizona 85224
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Chandler, AZ
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Charleston, South Carolina 29407
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Charleston, SC
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Charlottesville, Virginia 22904
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Charlottesville, VA
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Cincinnati, Ohio 45229
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Cincinnati, OH
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Cincinnati, Ohio 45229
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Columbia, South Carolina 29201
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Denver, Colorado 80262
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Glendale, Arizona 85308
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Greenbrae, California 94904
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Greenbrae, CA
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Hollywood, Florida 33021
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Hollywood, FL
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Irving, Texas 75062
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Irving, TX
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Jackson, Mississippi 39209
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Jackson, MS
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Miami, Florida 33136
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Miami, FL
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Midlothian, Virginia 23114
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Midlothian, VA
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Mogadore, Ohio 44260
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O'Fallon, Illinois 62269
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O'Fallon, IL
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Opelousas, Louisiana 70570
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Opelousas, LA
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Pembroke Pines, Florida 33024
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San Antonio, Texas 78207
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San Antonio, Texas 78207
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San Diego, California 92123
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San Diego, CA
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Santa Rosa, California 95405
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Santa Rosa, CA
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Shelby, North Carolina 28152
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Simpsonville, South Carolina 29681
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Spring Valley, California 91978
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St. Louis, Missouri 63110
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St. Louis, Missouri 63110
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St. Peters, Missouri 63376
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Tacoma, Washington 98405
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Tacoma, WA
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Tampa, Florida 33613
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Tampa, FL
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Temecula, California 92591
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Temecula, CA
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Varnville, South Carolina 29944
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Varnville, SC
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