Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:35 - Any
Updated:10/2/2013
Start Date:March 2009
End Date:January 2013
Contact:Novartis Pharmaceuticals
Phone:+1(862)778-8300

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Trial Summary
Trial Overview
Inclusion Criteria

A 104 Week, Randomized, Double Blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy of Aliskiren on the Progression of Atherosclerosis in Patients With Coronary Artery Disease When Added to Optimal Background Therapy


The study will assess the change in coronary atherosclerotic disease as determined by
intravascular ultrasound (IVUS) for aliskiren compared to placebo when given in addition to
standard therapy in patients with coronary artery disease (CAD) and a blood pressure in the
pre-hypertensive range.


Inclusion Criteria:

- Patients with CAD who have blood pressure in the pre-hypertensive range defined as a
msSBP ≥ 125 and ≤ 139mmHg and a msDBP < 90mmHg.

- Patients with or without current treatment for hypertension

- Angiographic evidence of coronary artery disease

- At least 2 qualifying Cardiovascular risk factors at Visit 1

Exclusion Criteria:

- Baseline IVUS determined unacceptable

- Patients requiring treatment with disallowed study medications

- Patients with clinically significant heart disease

- Previous or current diagnosis of heart failure (NYHA Class IV) or a documented left
ventricular ejection fraction of < 25%

- Patients requiring treatment with any 2 of the following classes of medication at
Visit 1 or Visit 2:

- Angiotensin converting enzyme inhibitors

- Angiotensin receptor blockers

- aldosterone receptor blockers or a direct renin inhibitor.

- Other conditions may apply
We found this trial at
29
sites
Novartis Investigative Site
Oklahoma City, Oklahoma 73104
848
mi
from 43215
Oklahoma City, OK
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Novartis Investigative Site
Albuquerque, New Mexico 87106
1331
mi
from 43215
Albuquerque, NM
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Novartis Investigative Site
Ann Arbor, Michigan 48109
164
mi
from 43215
Ann Arbor, MI
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Novartis Investigative site
Aurora, Colorado 80010
1155
mi
from 43215
Aurora, CO
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Novartis Investigative Site
Baltimore, Maryland 21236
349
mi
from 43215
Baltimore, MD
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Novartis Investigative Site
Beach Grove, Indiana 46107
206
mi
from 43215
Beach Grove, IN
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Novartis Investigative Site
Birmingham, Alabama 35294
493
mi
from 43215
Birmingham, AL
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Novartis Investigative Site
Bismark, North Dakota 58501
1005
mi
from 43215
Bismark, ND
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Novartis Investigative Site
Blue Bell, Pennsylvania 19422
409
mi
from 43215
Blue Bell, PA
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Novartis Investigative site
Boston, Massachusetts 02118
643
mi
from 43215
Boston, MA
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Novartis Investigative Site
Brick, New Jersey 08724
469
mi
from 43215
Brick, NJ
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Novartis Investigative Site
Cincinatti, Ohio 45219
98
mi
from 43215
Cincinatti, OH
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Novartis Investigative site
Dallas, Texas 75216
914
mi
from 43215
Dallas, TX
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Novartis Investigative site
Gainesville, Georgia 30501
393
mi
from 43215
Gainesville, GA
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Novartis Investigative Site
Hartford, Connecticut 06106
554
mi
from 43215
Hartford, CT
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Novartis Investigative Site
High Point, North Carolina 27262
321
mi
from 43215
High Point, NC
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Novartis Investigative Site
Knoxville, Tennessee 37934
280
mi
from 43215
Knoxville, TN
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Novartis Investigative site
Los Angeles, California 90095
1982
mi
from 43215
Los Angeles, CA
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Novartis Investigative Site
Louisville, Kentucky 40202
188
mi
from 43215
Louisville, KY
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Novartis Investigative Site
Miami, Florida 33136
993
mi
from 43215
Miami, FL
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Novartis Investigative Site
Mineola, New York 11501
496
mi
from 43215
Mineola, NY
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Novartis Investigative Site
New Orleans, Louisiana 70115
798
mi
from 43215
New Orleans, LA
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Novartis Investigative Site
Omaha, Nebraska 68144
691
mi
from 43215
Omaha, NE
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Novartis Investigative Site
Phoenix, Arizona 85012
1660
mi
from 43215
Phoenix, AZ
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Novartis
Portland, Oregon 97228
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
2028
mi
from 43215
Portland, OR
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Novartis Investigative Site
Rochester, Minnesota 55905
559
mi
from 43215
Rochester, MN
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Novartis Investigative Site
Salt Lake City, Utah 84103
1513
mi
from 43215
Salt Lake City, UT
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Novartis Investigative Site
St Louis, Missouri 63104
395
mi
from 43215
St Louis, MO
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Novartis Investigative Site
Washington, District of Columbia 20007
328
mi
from 43215
Washington,
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