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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00452725
Other study ID # MAX08
Secondary ID
Status Completed
Phase Phase 3
First received March 23, 2007
Last updated October 4, 2010
Start date October 1997
Est. completion date July 2010

Study information

Verified date October 2010
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

1. Clinical Objective : To improve the growth of these children

2. Genetic objective : A study of the genetics of the syndrome


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 15 Years
Eligibility Inclusion Criteria:

- Children and adolescents with Noonan's syndrome with a height < -2 SD and no progressive cardiopathy

Exclusion Criteria:

- Age < 3 years

- Height = -2 SD

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
MAXOMAT ®, biosynthetic growth hormone
2 posologies according to age (children and adolescents) treatment is planned for a 2 year duration

Locations

Country Name City State
France Sanofi-Aventis Paris

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of height : gain in height and rate of growth at each visit (every 3 months) or every 6 months No
Secondary Clinical and laboratory test safety every 6 months Yes
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