Effect of MAXOMAT ® on the Growth of Small Children to NOONAN's Syndrome

Phase 3

Completed

• Conditions: Noonan Syndrome

• Registration Number: NCT00452725
• Lead Sponsor: Sanofi

Brief Summary

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

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

Detailed Description

Not available

Study Timeline

• Study Start: 1997-10
• Study First Submitted: 2007-03-23
• Study First Submitted QC: 2007-03-26
• Study First Posted: 2007-03-27
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-04
• Last Update Posted: 2010-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluation of height : gain in height and rate of growth	at each visit (every 3 months) or every 6 months

Secondary Outcome Measures

Name	Time	Method
Clinical and laboratory test safety	every 6 months

Trial Locations

Locations (1)

Sanofi-Aventis; 🇫🇷 Paris, France