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A Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Examine the Effect of Nebivolol, a Beta-Blockade Drug, for the Prevention of Ventricular Systolic Dysfunction in Patients With Duchenne Muscular Dystrophy
The objective is to determine whether nebivolol, a beta-blockade drug, can prevent the development of heart disease in patients with Duchenne muscular dystrophy aged 10 to 15 year-old.
A 1.25 mg-test dose will be administrated to assess the treatment tolerance before randomization. A forced titration of nebivolol and placebo will be performed with 2 weeks periods. Full dose of nebivolol and placebo is 5mg/day (7.5mg/day for patients whose weight is\>60kg).
Age
10 - 15 years
Sex
MALE
Healthy Volunteers
No
Armand Trousseau Hospital
Paris, France
Start Date
February 13, 2012
Primary Completion Date
July 20, 2021
Completion Date
July 20, 2021
Last Updated
November 20, 2025
51
ACTUAL participants
Nebivolol
DRUG
Placebo
DRUG
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
NCT01143454
NCT05836259
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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