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

Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS

Change from baseline in normalized total atheroma volume (TAV) (mm\^3) for all matched slices of anatomically comparable segments of the target coronary artery were assess by IVUS 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

Time frame: Baseline, 104 weeks

Patients That Demonstrated Evidence of Atheroma Regression

Atheroma regression is defined as change from baseline to endpoint in PAV \<0 .

Time frame: Baseline to endpoint (104 weeks)

Number of Patients With Adverse Events, Serious Adverse Events, and Death

overall safety and tolerability of aliskiren 300 mg compared to placebo in patients with CAD and BP in the pre-hypertensive (high normal) range with or without treatment for hypertension following 104 weeks of treatment. Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity.

Time frame: 104 weeks