NCT01648634

Nebivolol for the Prevention of Left Ventricular Systolic Dysfunction in Patients With Duchenne Muscular Dystrophy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Male
• Age: 10 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Duchenne Muscular Dystrophy
• Cardiomyopathy
• Heart Failure

Interventions

Type	Name	Description
DRUG	Nebivolol	A 1.25mg-test dose will be administrated to assess the treatment tolerance before randomization. A forced titration of nebivolol will be performed with 2 weeks periods. Full dose of nebivolol is 5mg/day (7.5mg/day for patients whose weight is\>60kg)
DRUG	Placebo	A 1.25mg-test dose of nebivolol will be administrated to assess the treatment tolerance before randomization. A forced titration of placebo will be performed with 2 weeks periods. Full dose of placebo is 5mg/day (7.5mg/day for patients whose weight is\>60kg)

Timeline

• Start date: 2012-02-13
• Primary completion: 2021-07-20
• Completion: 2021-07-20
• First posted: 2012-07-24
• Last updated: 2025-11-20

Locations

1 site across 1 country: France