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
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Coronary Artery Disease (CAD)
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 613
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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 patients with coronary artery disease (CAD) and a blood pressure in the pre-hypertensive range.
Investigators
Eligibility 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
Arms & Interventions
1
Intervention: Placebo
2
Aliskiren 300 mg
Intervention: Aliskiren
Outcomes
Primary Outcomes
Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment
Time Frame: Baseline, 104 weeks
Change from baseline in PAV for all matched slices of anatomically comparable segments of the target coronary artery were assessed by intravascular ultrasound (IVUS) evaluation after 104 weeks of treatment . calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases
Secondary Outcomes
- Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS(Baseline, 104 weeks)
- Patients That Demonstrated Evidence of Atheroma Regression(Baseline to endpoint (104 weeks))
- Number of Patients With Adverse Events, Serious Adverse Events, and Death(104 weeks)