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

ISRCTN	ISRCTN49075167
DOI	https://doi.org/10.1186/ISRCTN49075167
EudraCT/CTIS number	2008-003856-32
Secondary identifying numbers	CL3-90652-004

Submission date: 16/01/2009
Registration date: 16/02/2009
Last edited: 21/04/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration and not expected to be available in the future

Contact information

Prof Isabelle Desguerre
Scientific

Groupe hospitalier Necker - Enfants Malades
149 rue de Sèvres
Paris Cedex 15
75743
France

Study information

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
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study objectives	Effect on peripheral muscular function.
Ethics approval(s)	Ethics approval was obtained before recruitment of the first participants
Health condition(s) or problem(s) studied	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
Completion date	30/09/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	7 Years
Sex	Male
Target number of participants	40
Total final enrolment	40
Key inclusion criteria	Children, less than 7 years old with Duchenne Muscular Dystrophy and able to complete a 6-minute walk test
Key exclusion criteria	1. Long term treatment with corticoids 2. Treatment with ACE inhibitors or AT1 antagonists
Date of first enrolment	01/02/2009
Date of final enrolment	30/09/2012

Locations

Countries of recruitment

France

Study participating centre

Groupe hospitalier Necker - Enfants Malades

Paris Cedex 15
75743
France

Sponsor information

Institut de Recherches Internationales Servier (France)
Industry

50 rue Carnot
Suresnes
92284
France

Website	http://www.servier.com/
"ROR"	https://ror.org/034e7c066

Funders

Funder type

Industry

Institut de Recherches Internationales Servier (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results				No	No
Basic results			21/04/2020	No	No

Editorial Notes

21/04/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
23/11/2018: Link to basic results added.