Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients (AQUARIUS)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
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Baseline IVUS determined unacceptable
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Patients requiring treatment with disallowed study medications
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Patients with clinically significant heart disease
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Previous or current diagnosis of heart failure (NYHA Class IV) or a documented left ventricular ejection fraction of < 25%
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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.
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Other conditions may apply
Trial design
Primary purpose
Allocation
Interventional model
Masking
613 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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