Status:
COMPLETED
MAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation on Pre-pubertal Children
Lead Sponsor:
Sanofi
Conditions:
Fetal Growth Retardation
Eligibility:
All Genders
3-11 years
Phase:
PHASE3
Brief Summary
1. To test for equivalence in terms of catch-up growth between the 2 therapeutic regimens 2. To specify the best period of treatment 3. To assess the efficacy of treatment based on final adult height ...
Eligibility Criteria
Inclusion
- Pre-pubertal children of either sex presenting with severe early onset intrauterine growth retardation (I.U.G.R.)
- Height Less Than or Equal to -3 SD
Exclusion
- Age less than 3 years
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
May 1 1993
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT00452491
Start Date
May 1 1993
End Date
April 1 2010
Last Update
October 5 2010
Active Locations (1)
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1
Sanofi-Aventis
Paris, France