Additional identifiers
EudraCT/CTIS number
2008-003856-32
IRAS number
ClinicalTrials.gov number
Protocol/serial number
CL3-90652-004
Study information
Scientific title
Assessment of the effect of perindopril orodispersible tablet at the dose of 0.150 mg/kg/day on muscular and myocardic functions in the early stage of Duchenne Muscular Dystrophy: a two-year, double-blind, randomised, placebo-controlled study
Acronym
Study hypothesis
Effect on peripheral muscular function.
Ethics approval(s)
Ethics approval was obtained before recruitment of the first participants
Study design
Double-blind randomised placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Duchenne Muscular Dystrophy
Intervention
Perindopril orodispersible tablet 0.150 mg/kg/day versus placebo for two years.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Perindopril
Primary outcome measure
Six-minute walking distance, evaluated each 6 months
Secondary outcome measures
1. Other muscular tests
2. Echocardiography
3. Respiratory function assessment
Evaluated at inclusion visit and end-of-study visit
Overall study start date
01/02/2009
Overall study end date
30/09/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Children, less than 7 years old with Duchenne Muscular Dystrophy and able to complete a 6-minute walk test
Participant type(s)
Patient
Age group
Child
Upper age limit
7 Years
Sex
Male
Target number of participants
40
Total final enrolment
40
Participant exclusion criteria
1. Long term treatment with corticoids
2. Treatment with ACE inhibitors or AT1 antagonists
Recruitment start date
01/02/2009
Recruitment end date
30/09/2012
Locations
Countries of recruitment
France
Study participating centre
Groupe hospitalier Necker - Enfants Malades
Paris Cedex 15
75743
France
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Institut de Recherches Internationales Servier (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Basic results | 21/04/2020 | No | No |