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Safety and Efficacy of Aliski...

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

Last Updated: 2014-06-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

613 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease (CAD) Coronary Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

2

Aliskiren 300 mg

Group Type EXPERIMENTAL

Aliskiren

Intervention Type DRUG

300 mg

Interventions

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Placebo

Intervention Type DRUG

Aliskiren

300 mg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Novartis

Role: STUDY_DIRECTOR

Novartis

Locations

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Novartis Investigative Site

Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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Stockton, California, United States

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Torrance, California, United States

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Boulder, Colorado, United States

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Farmington, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Washington D.C., District of Columbia, United States

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Gainesville, Florida, United States

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Hudson, Florida, United States

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Miami, Florida, United States

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Port Charlotte, Florida, United States

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Safety Harbor, Florida, United States

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Decatur, Georgia, United States

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Elkhart, Indiana, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Covington, Louisiana, United States

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Columbia, Maryland, United States

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Boston, Massachusetts, United States

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Flint, Michigan, United States

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Kalamazoo, Michigan, United States

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Midland, Michigan, United States

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Petoskey, Michigan, United States

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Saginaw, Michigan, United States

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Rochester, Minnesota, United States

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Saint Paul, Minnesota, United States

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Columbia, Missouri, United States

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Ridgewood, New Jersey, United States

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Albuquerque, New Mexico, United States

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Buffalo, New York, United States

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New York, New York, United States

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Syracuse, New York, United States

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Williamsville, New York, United States

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Raleigh, North Carolina, United States

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Fargo, North Dakota, United States

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Cleveland, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Bend, Oregon, United States

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Hillsboro, Oregon, United States

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Danville, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Johnson City, Tennessee, United States

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Memphis, Tennessee, United States

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Oak Ridge, Tennessee, United States

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Dallas, Texas, United States

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Katy, Texas, United States

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