Condition category
Nervous System Diseases
Date applied
16/01/2009
Date assigned
16/02/2009
Last edited
08/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Isabelle Desguerre

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2008-003856-32

ClinicalTrials.gov number

Protocol/serial number

CL3-90652-004

Study information

Scientific title

Acronym

Study hypothesis

Effect on peripheral muscular function.

Ethics approval

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

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below 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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/02/2009

Overall trial end date

30/09/2012

Reason abandoned

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

Patient

Age group

Child

Gender

Male

Target number of participants

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

Trial 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

http://www.servier.com/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes