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Aliskiren Effect on Aortic Plaque Progression

NCT01417104 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2017-05-11

Study results available
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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.

Conditions

Interventions

DRUG

Aliskiren

150 mg/300mg

DRUG

Placebo

150mg/300mg

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Ohio State University

    lead OTHER

Principal Investigators

  • Sanjay Rajagopalan, MD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-12-31
Completion
2012-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01417104 on ClinicalTrials.gov