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Clinical Trials/NCT00076362
NCT00076362
Completed
Phase 4

Pediatric Hypothalamic Obesity

Novartis Pharmaceuticals15 sites in 1 country60 target enrollmentMarch 2004
ConditionsObesity

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Obesity
Sponsor
Novartis Pharmaceuticals
Enrollment
60
Locations
15
Primary Endpoint
Change from baseline in BMI
Status
Completed
Last Updated
14 years ago

Overview

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 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.

Registry
clinicaltrials.gov
Start Date
March 2004
End Date
July 2005
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change from baseline in BMI

Secondary Outcomes

  • 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

Study Sites (15)

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