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Pediatric Hypothalamic Obesity
This study has been completed.
Study NCT00076362   Information provided by Novartis
First Received: January 21, 2004   Last Updated: November 18, 2009   History of Changes

January 21, 2004
November 18, 2009
March 2004
 
Change from baseline in BMI
Same as current
Complete list of historical versions of study NCT00076362 on ClinicalTrials.gov Archive Site
Change from baseline in weight, leptin, insulin AUC, C-peptide AUC, amylin AUC, glucose AUC, dietary intake, physical activity, waist-to-hip ratio, visceral and subcutaneous abdominal fat
Same as current
 
Pediatric Hypothalamic Obesity
 

This trial is being conducted in pediatric patients with Hypothalamic Obesity. This generally occurs in people who have had an injury to or tumor in their hypothalamus (gland or organ that secretes hormones). The purpose of this trial is to see how an investigational treatment controls the hormone insulin by lowering the level of insulin in the body resulting in a weight loss in children who are at least 6 years of age but less than 18 years of age. Some children in this trial will receive placebo.

To qualify for this study, you and your child's doctor must feel that your child's weight is inadequately controlled within a year from the time of injury to the hypothalamus or tumor of the hypothalamus. This study will help to determine if an investigational treatment is of benefit in controlling a child's weight.

 
Phase IV
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Obesity
Drug: Sandostatin LAR
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
60
 
 
  • Male and female patients ages 6 to less than 18
  • Patients who have experienced any form of cranial insult related to cranial trauma, or to a tumor or it's treatment (i.e. surgery, radiation, and/or chemotherapy)
  • Patients who are at least one year out following therapy for their tumor
  • Patients who have severe cardiovascular dysfunction (for example cardiomyopathy, congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation) will be excluded
  • Patients with severe neurologic handicaps which preclude normal physical activity will be excluded.
  • Patients confined to bed and those patients who are wheelchair bound which prevents them from activities of daily living or normal physical activity, i.e. walking, will be excluded from the trial
  • Your child must be greater than 120% of their ideal body weight for their height or have a body mass index that is greater than or equal to 27.
Both
6 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00076362
 
CSMS995B2403
Novartis Pharmaceuticals
 
Study Chair: Novartis Novartis
Novartis
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP