Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-01-22 @ 3:22 PM
Study NCT ID:
NCT01648634
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2012-07-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nebivolol for the Prevention of Left Ventricular Systolic Dysfunction in Patients With Duchenne Muscular Dystrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020388', 'term': 'Muscular Dystrophy, Duchenne'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D009136', 'term': 'Muscular Dystrophies'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068577', 'term': 'Nebivolol'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2012-07-20', 'studyFirstSubmitQcDate': '2012-07-23', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left ventricular systolic dysfunction', 'timeFrame': 'at 5 years', 'description': 'Development of left ventricular systolic dysfunction with an ejection fraction \\< 45%'}], 'secondaryOutcomes': [{'measure': 'Right ventricular ejection fraction', 'timeFrame': 'at 5 years', 'description': 'Right ventricular ejection fraction assessed by radionuclide angiography or echocardiography'}, {'measure': 'NT-ProBNP', 'timeFrame': 'at 1, 2, 3, 4, and 5 years', 'description': 'NT-ProBNP'}, {'measure': 'Left ventricular dysfunction', 'timeFrame': 'at 10 years', 'description': 'Development of left ventricular dysfunction'}, {'measure': 'Hospitalizations', 'timeFrame': 'at 10 years', 'description': 'hospitalizations for heart failure'}, {'measure': 'Mortality', 'timeFrame': 'at 10 years ((5-years open label extension)', 'description': 'Cardiovascular mortality'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nebivolol', 'beta-blockade treatment'], 'conditions': ['Duchenne Muscular Dystrophy', 'Cardiomyopathy', 'Heart Failure']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Duchenne muscular dystrophy genetically proven\n* Age between 10 and 15 years\n* Left ventricular ejection fraction assessed by radionuclide angiography or echocardiography ≥50% and measured within 3 months\n* Systolic blood pressure ≥80 mmHg\n* Diastolic blood pressure ≥70 mmHg\n\nExclusion Criteria:\n\n* Heart rate \\<50 bpm\n* 2nd or 3rd degree atrioventricular blocks, sinus node dysfunction\n* Asthma or bronchospasm\n* Severe peripheral circulatory disease\n* Hypersensitivity to nebivolol or excipients\n* Metabolic acidosis\n* Blood urea \\>7 mmol/l\n* Liver transaminases enzymes \\>6 fold the upper limit of normal\n* Formal indication for beta-blockade treatment\n* Cardiac treatments except angiotensin-converting enzyme inhibitors\n* Participation to another clinical trial within 3 months'}, 'identificationModule': {'nctId': 'NCT01648634', 'acronym': 'NEBIDYS', 'briefTitle': 'Nebivolol for the Prevention of Left Ventricular Systolic Dysfunction in Patients With Duchenne Muscular Dystrophy', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'P090202'}, 'secondaryIdInfos': [{'id': '2010-020047-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nebivolol', 'interventionNames': ['Drug: Nebivolol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Nebivolol', 'type': 'DRUG', 'description': '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)', 'armGroupLabels': ['Nebivolol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '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)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Armand Trousseau Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Henri-Marc BECANE, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Armand Trousseau Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Association Française contre les Myopathies (AFM), Paris', 'class': 'OTHER'}, {'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}