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 |
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 Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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