NCT00853827

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 613 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease (CAD)
• Coronary Atherosclerosis

Interventions

Type	Name	Description
DRUG	Placebo	Placebo
DRUG	Aliskiren	300 mg

Timeline

• Start date: 2009-03-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2009-03-02
• Last updated: 2014-06-03
• Results posted: 2014-05-07

Locations

129 sites across 11 countries: United States, Argentina, Australia, Belgium, Canada, France, Germany, Hungary, Italy, Poland, Spain