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

Use our guide to learn which trials are right for you!

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
Temecula, California 92591
?
mi
from
Temecula, CA
Click here to add this to my saved trials
Belzoni, Mississippi 39038
?
mi
from
Belzoni, MS
Click here to add this to my saved trials
Binghamton, New York 13901
?
mi
from
Binghamton, NY
Click here to add this to my saved trials
Birmingham, Alabama 35209
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Chandler, Arizona 85224
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Charleston, South Carolina 29407
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlottesville, Virginia 22904
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Cincinnati, Ohio 45229
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, Ohio 45229
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Columbia, South Carolina 29201
?
mi
from
Columbia, SC
Click here to add this to my saved trials
Denver, Colorado 80262
?
mi
from
Denver, CO
Click here to add this to my saved trials
Glendale, Arizona 85308
?
mi
from
Glendale, AZ
Click here to add this to my saved trials
Greenbrae, California 94904
?
mi
from
Greenbrae, CA
Click here to add this to my saved trials
Hollywood, Florida 33021
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Irving, Texas 75062
?
mi
from
Irving, TX
Click here to add this to my saved trials
Jackson, Mississippi 39209
?
mi
from
Jackson, MS
Click here to add this to my saved trials
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
Midlothian, Virginia 23114
?
mi
from
Midlothian, VA
Click here to add this to my saved trials
Mogadore, Ohio 44260
?
mi
from
Mogadore, OH
Click here to add this to my saved trials
O'Fallon, Illinois 62269
?
mi
from
O'Fallon, IL
Click here to add this to my saved trials
Opelousas, Louisiana 70570
?
mi
from
Opelousas, LA
Click here to add this to my saved trials
Pembroke Pines, Florida 33024
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
Plano, Texas 75024
?
mi
from
Plano, TX
Click here to add this to my saved trials
San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Santa Rosa, California 95405
?
mi
from
Santa Rosa, CA
Click here to add this to my saved trials
Shelby, North Carolina 28152
?
mi
from
Shelby, NC
Click here to add this to my saved trials
Simpsonville, South Carolina 29681
?
mi
from
Simpsonville, SC
Click here to add this to my saved trials
Spring Valley, California 91978
?
mi
from
Spring Valley, CA
Click here to add this to my saved trials
St. Louis, Missouri 63110
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
St. Louis, Missouri 63110
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
St. Peters, Missouri 63376
?
mi
from
St. Peters, MO
Click here to add this to my saved trials
Tacoma, Washington 98405
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Tampa, Florida 33613
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Varnville, South Carolina 29944
?
mi
from
Varnville, SC
Click here to add this to my saved trials