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Phase 4
6 Years
18 Years
Not Enrolling

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Trial Information

Inclusion Criteria

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Change from baseline in BMI

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

March 2004

Completion Date:

Related Keywords:

  • Obesity
  • Obesity



Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Children's Hospital of Orange CountyOrange, California  92668
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
University of ColoradoDenver, Colorado  80217
Duke University Medical CenterDurham, North Carolina  27710
Washington UniversitySt. Louis, Missouri  63110
Texas Children's HospitalHouston, Texas  
University of California at San FranciscoSan Francisco, California  94115
Miami Children'S HopitalMiami, Florida  33155
Childrens Memorial HospitalChicago, Illinois  60614
St. Vincent Children's Center for Cancer and Blood DiseasesIndianapolis, Indiana  46260
U of Tennessee HELP CenterMemphis, Tennessee  38103
UT Southwestern Children's Medical Center of DallasDallas, Texas  75390