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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01648634
Other study ID # P090202
Secondary ID 2010-020047-12
Status Completed
Phase Phase 3
First received
Last updated
Start date February 13, 2012
Est. completion date July 20, 2021

Study information

Verified date September 2021
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date July 20, 2021
Est. primary completion date July 20, 2021
Accepts healthy volunteers No
Gender Male
Age group 10 Years to 15 Years
Eligibility Inclusion Criteria: - Duchenne muscular dystrophy genetically proven - Age between 10 and 15 years - Left ventricular ejection fraction assessed by radionuclide angiography or echocardiography =50% and measured within 3 months - Systolic blood pressure =80 mmHg - Diastolic blood pressure =70 mmHg Exclusion Criteria: - Heart rate <50 bpm - 2nd or 3rd degree atrioventricular blocks, sinus node dysfunction - Asthma or bronchospasm - Severe peripheral circulatory disease - Hypersensitivity to nebivolol or excipients - Metabolic acidosis - Blood urea >7 mmol/l - Liver transaminases enzymes >6 fold the upper limit of normal - Formal indication for beta-blockade treatment - Cardiac treatments except angiotensin-converting enzyme inhibitors - Participation to another clinical trial within 3 months

Study Design


Intervention

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)
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)

Locations

Country Name City State
France Armand Trousseau Hospital Paris

Sponsors (2)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Association Française contre les Myopathies (AFM), Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Left ventricular systolic dysfunction Development of left ventricular systolic dysfunction with an ejection fraction < 45% at 5 years
Secondary Right ventricular ejection fraction Right ventricular ejection fraction assessed by radionuclide angiography or echocardiography at 5 years
Secondary NT-ProBNP NT-ProBNP at 1, 2, 3, 4, and 5 years
Secondary Left ventricular dysfunction Development of left ventricular dysfunction at 10 years
Secondary Hospitalizations hospitalizations for heart failure at 10 years
Secondary Mortality Cardiovascular mortality at 10 years ((5-years open label extension)
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