Status:
COMPLETED
Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients
Lead Sponsor:
Novartis Pharmaceuticals
Collaborating Sponsors:
The Cleveland Clinic
Conditions:
Coronary Artery Disease (CAD)
Coronary Atherosclerosis
Eligibility:
All Genders
35+ years
Phase:
PHASE3
Brief 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 pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
613 Patients enrolled
Trial Details
Trial ID
NCT00853827
Start Date
March 1 2009
End Date
January 1 2013
Last Update
June 3 2014
Active Locations (129)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Mobile, Alabama, United States, 36693
2
Novartis Investigative Site
Phoenix, Arizona, United States, 85054
3
Novartis Investigative Site
Tucson, Arizona, United States, 85723-0001
4
Novartis Investigative Site
Tucson, Arizona, United States, 85745