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

Completed · Phase 3 · Has a placebo group

Conditions studied: Coronary Artery Disease (CAD), Coronary Atherosclerosis

In brief

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.

Key facts

Study ID

NCT00853827

Run by

Novartis Pharmaceuticals

People needed

613

Starts

2009-03-01

Expected to finish

2013-01-01

Last updated by the study team

2014-06-03

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Tucson, Arizona, United States
• Novartis Investigative Site — Tucson, Arizona, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Stockton, California, United States
• Novartis Investigative Site — Torrance, California, United States
• Novartis Investigative Site — Boulder, Colorado, United States
• Novartis Investigative Site — Farmington, Connecticut, United States
• Novartis Investigative Site — Washington D.C., District of Columbia, United States
• Novartis Investigative Site — Washington D.C., District of Columbia, United States
• Novartis Investigative Site — Gainesville, Florida, United States
• Novartis Investigative Site — Hudson, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Port Charlotte, Florida, United States
• Novartis Investigative Site — Safety Harbor, Florida, United States
• Novartis Investigative Site — Decatur, Georgia, United States
• Novartis Investigative Site — Elkhart, Indiana, United States
• Novartis Investigative Site — Lexington, Kentucky, United States
• Novartis Investigative Site — Louisville, Kentucky, United States
• Novartis Investigative Site — Covington, Louisiana, United States
• Novartis Investigative Site — Columbia, Maryland, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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