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Register:	ISRCTN
Last refreshed on:	4 May 2020
Main ID:	ISRCTN49075167
Date of registration:	16/02/2009
Prospective Registration:	No
Primary sponsor:	Institut de Recherches Internationales Servier (France)
Public 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
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
Date of first enrolment:	01/02/2009
Target sample size:	40
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN49075167
Study type:	Interventional
Study design:	Double-blind randomised placebo-controlled study (Treatment)
Phase:	Not Applicable

Countries of recruitment
France

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Isabelle Desguerre
Address:	Groupe hospitalier Necker - Enfants Malades 149 rue de Sèvres 75743 Paris Cedex 15 France
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: Children, less than 7 years old with Duchenne Muscular Dystrophy and able to complete a 6-minute walk test
Exclusion criteria:
1. Long term treatment with corticoids
2. Treatment with ACE inhibitors or AT1 antagonists

Age minimum:
Age maximum:
Gender: Male

Health Condition(s) or Problem(s) studied

Duchenne Muscular Dystrophy
Nervous System Diseases
Primary disorders of muscles

Intervention(s)

Perindopril orodispersible tablet 0.150 mg/kg/day versus placebo for two years.

Primary Outcome(s)

Six-minute walking distance, evaluated each 6 months

Secondary Outcome(s)

1. Other muscular tests
2. Echocardiography
3. Respiratory function assessment

Evaluated at inclusion visit and end-of-study visit

Secondary ID(s)

2008-003856-32

CL3-90652-004

Source(s) of Monetary Support

Institut de Recherches Internationales Servier (France)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Ethics approval was obtained before recruitment of the first participants

Results

Results available:	Yes
Date Posted:
Date Completed:	30/09/2012
URL:

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