Status:
COMPLETED
Pediatric Hypothalamic Obesity
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Obesity
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
Brief Summary
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 ho...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00076362
Start Date
March 1 2004
Last Update
September 12 2011
Active Locations (15)
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1
Phoenix Children'S Hospital
Phoenix, Arizona, United States, 85016
2
Children's Hospital of Orange County
Orange, California, United States, 92868
3
University of California at San Francisco
San Francisco, California, United States, 94143
4
University of Colorado
Denver, Colorado, United States, 80218