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Completed

NCT Number: NCT00452725

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

1. Clinical Objective : To improve the growth of these children 2. Genetic objective : A study of the genetics of the syndrome

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Key information

Conditions

Noonan Syndrome Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Craniofacial Abnormalities Heart Defects, Congenital Heart Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Skin and Connective Tissue Diseases

Age range

3 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MAXOMAT ®, biosynthetic growth hormone

Drug

2 posologies according to age (children and adolescents) treatment is planned for a 2 year duration

Primary outcomes

  1. Evaluation of height : gain in height and rate of growth

    Time frame: at each visit (every 3 months) or every 6 months

Secondary outcomes

  1. Clinical and laboratory test safety

    Time frame: every 6 months

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Effect of the Growth Hormone MAXOMAT ® on the Growth of Small Children and Adolescents (<-2 SD) Due to NOONAN's Syndrome

Important dates

Study start
1997
Primary completion
2010
Study completion
2010
First posted
Mar 27, 2007
Registry last updated
Oct 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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