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

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Collaborator: The Cleveland Clinic

Criteria

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