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The Effect of Tekturna on Endothelial Function and Endothelial Progenitor Cells in Patients With Early Atherosclerosis

NCT01067326 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2013-02-13

Study results available
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Summary

We will study the hypothesis that long-term Tekturna treatment will improve endothelial function and the production and function of endothelial progenitor cells (EPCs) in patients with early atherosclerosis. Specifically, long-term Tekturna treatment will increase the Reactive Hyperemia Peripheral Arterial Tonometry indexes and increase the numbers and the function of circulating endothelial progenitor cells, compared to placebo, in association with a reduction in inflammation and oxidative stress.

Conditions

  • Endothelial Dysfunction

Interventions

DRUG

Aliskiren

150 mg Aliskiren once daily for a period of 4 months

DRUG

Placebo

1 pill per day by mouth for 4 months

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Novartis

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Amir Lerman, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01067326 on ClinicalTrials.gov