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Revatio for Heart Disease in Duchenne Muscular Dystrophy and Becker Muscular Dystrophy

NCT01168908 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-02-26

Study results available
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Summary

This study, supported by Charley's Fund, Inc., is being done to determine if the drug Revatio®(also known as Sildenafil), as compared to placebo (an inactive substance that looks like the study drug, but contains no medication), improves heart function in people with Duchenne Muscular Dystrophy and Becker Muscular Dystrophy (DBMD).

In people with DBMD, dystrophin is not present or lacking in heart and muscle. This is associated with abnormalities in an enzyme called "neuronal nitric oxide synthase" or nNOS, and leads to decreases in "cyclic GMP," which is necessary for proper function of those muscles. Revatio blocks an enzyme called phosphodiesterase 5 (PDE5), and helps to restore the normal amounts of cyclic GMP. The purpose of this research is to determine if Revatio is safe for people with DBMD and if it can improve heart function.

Hypothesis : PDE5 inhibition, with the use of Revatio, will improve cardiac function in patients with DBMD.

Conditions

Interventions

DRUG

Sildenafil

20mg tablet three times daily

Sponsors & Collaborators

Principal Investigators

  • Daniel P Judge, MD · Johns Hopkins School of Medicine

  • Kathryn R. Wagner, M.D., Ph.D. · The Kennedy Krieger Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States

Study Locations

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Entities

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 NCT01168908 on ClinicalTrials.gov