NCT00076362|CompletedPhase 4
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Sponsor study identifier
interventional
60
1 country
15
Study Start
March 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2005
Actual (reported)Study Completion
Not reported
Date not reportedThis 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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 21, 2004
Actual (reported)January 23, 2004
Actual (reported)March 2004
Date type not reportedThis date has not been verified as actual or estimated.
July 2005
Actual (reported)Change from baseline in BMI
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Phoenix Children'S Hospital
Phoenix, Arizona, 85016, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
University of California at San Francisco
San Francisco, California, 94143, United States
University of Colorado
Denver, Colorado, 80218, United States
Miami Children'S Hopital
Miami, Florida, 33155, United States
Childrens Memorial Hospital
Chicago, Illinois, 60614, United States
St. Vincent Children's Center for Cancer and Blood Diseases
Novartis Pharmaceuticals
Novartis Pharmaceuticals
60 participants (actual enrollment reported by the registry).
First Submitted
January 21, 2004
First Posted
January 23, 2004
Study Start
March 2004
Date type not reportedThis date has not been verified as actual or estimated.
The Effects of Pentoxifylline on PAI-1 in an Obese Population
Indianapolis, Indiana, 46260, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Washington University
St Louis, Missouri, 63110, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
U of Tennessee HELP Center
Memphis, Tennessee, 38103, United States
UT Southwestern Children's Medical Center of Dallas
Dallas, Texas, 75390, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Primary Completion
July 2005
Actual (reported)Last Updated
September 12, 2011
Record last verified: 2011-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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