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 |
| Clinical Trials Information System (CTIS) | 2008-003856-32 |
| Protocol serial number | CL3-90652-004 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- 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
Scientific
Groupe hospitalier Necker - Enfants Malades
149 rue de Sèvres
Paris Cedex 15
75743
France
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind randomised placebo-controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Perindopril |
| Primary outcome measure(s) |
Six-minute walking distance, evaluated each 6 months |
| Key secondary outcome measure(s) |
1. Other muscular tests |
| Completion date | 30/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 7 Years |
| Sex | Male |
| Target sample size at registration | 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
75743
France
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
