drugset / Trial / NCT01417104

Aliskiren Effect on Aortic Plaque Progression

NCT01417104

Phase 2/3 Terminated 71 enrolled Ohio State University Novartis · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is being done to assess the effectiveness of short term (\~9 months) Aliskiren/Placebo therapy to slow down the progression of atherosclerotic disease in thoracic and abdominal aorta. This will be checked by comparing before and after therapy magnetic resonance imaging (MRI) pictures of the aortic wall. Aliskiren is an FDA approved drug for hypertension but in this study is used for a new indication. Recent studies with animals have shown that Aliskiren therapy reduces the atherosclerotic plaque. Therefore, in this study, the investigators would like to evaluate whether the investigational drug Aliskiren, which is not FDA approved for this indication has the same beneficial effects in people with atherosclerotic disease.

Timeline

Start
2009-10
Primary completion
2011-12
Completion
2012-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aliskiren Small molecule 300 mg Oral

Indications