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Generated: December 15, 2018

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CLINICAL TRIALS PROFILE FOR XENICAL

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Clinical Trials for Xenical

Trial ID Title Status Sponsor Phase Summary
NCT00001723 Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 Obesity is a condition affecting one-third off the U.S. population and is a major risk actor for the development of Type 2 diabetes, hyperlipidemia (increased levels of fat in the blood), hypertension (high blood pressure), and other disorders of the heart and lungs. Individuals with the onset of obesity during childhood or adolescence are at an increased risk of obesity-related, diseases, both during adolescence and later in adult life. African American girls and women are at an increased risk for obesity, and have substantial rates of obesity-related diseases and causes of death. Further, many African American adult women fail to respond to many of the therapeutic approaches used to treat obesity. At present there are no medical therapies proven effective for the correction of severe obesity in children or adolescents. One medication that may have a favorable risk-benefit ratio in pediatric populations is Orlistat (Xenical, Hoffmann LaRoche). Orlistat works by preventing the action of enzymes in the digestive process, interfering with the absorption of approximately 1/3 of the fat eaten in the diet. Xenical appears to be effective for reducing weight and obesity-associated diseases in obese adults. Researchers propose to determine the safety, tolerability, and efficacy of Xenical in 12-17 year old severely obese African American and Caucasian children and adolescents who have one or more obesity-related disease (hypertension, hyperlipidemia, sleep apnea, hepatic steatosis, insulin resistance, impaired glucose tolerance, or Type 2 diabetes).
NCT00001723 Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases Completed Roche Pharma AG Phase 2 Obesity is a condition affecting one-third off the U.S. population and is a major risk actor for the development of Type 2 diabetes, hyperlipidemia (increased levels of fat in the blood), hypertension (high blood pressure), and other disorders of the heart and lungs. Individuals with the onset of obesity during childhood or adolescence are at an increased risk of obesity-related, diseases, both during adolescence and later in adult life. African American girls and women are at an increased risk for obesity, and have substantial rates of obesity-related diseases and causes of death. Further, many African American adult women fail to respond to many of the therapeutic approaches used to treat obesity. At present there are no medical therapies proven effective for the correction of severe obesity in children or adolescents. One medication that may have a favorable risk-benefit ratio in pediatric populations is Orlistat (Xenical, Hoffmann LaRoche). Orlistat works by preventing the action of enzymes in the digestive process, interfering with the absorption of approximately 1/3 of the fat eaten in the diet. Xenical appears to be effective for reducing weight and obesity-associated diseases in obese adults. Researchers propose to determine the safety, tolerability, and efficacy of Xenical in 12-17 year old severely obese African American and Caucasian children and adolescents who have one or more obesity-related disease (hypertension, hyperlipidemia, sleep apnea, hepatic steatosis, insulin resistance, impaired glucose tolerance, or Type 2 diabetes).
NCT00001723 Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases Completed Jack Yanovski Phase 2 Obesity is a condition affecting one-third off the U.S. population and is a major risk actor for the development of Type 2 diabetes, hyperlipidemia (increased levels of fat in the blood), hypertension (high blood pressure), and other disorders of the heart and lungs. Individuals with the onset of obesity during childhood or adolescence are at an increased risk of obesity-related, diseases, both during adolescence and later in adult life. African American girls and women are at an increased risk for obesity, and have substantial rates of obesity-related diseases and causes of death. Further, many African American adult women fail to respond to many of the therapeutic approaches used to treat obesity. At present there are no medical therapies proven effective for the correction of severe obesity in children or adolescents. One medication that may have a favorable risk-benefit ratio in pediatric populations is Orlistat (Xenical, Hoffmann LaRoche). Orlistat works by preventing the action of enzymes in the digestive process, interfering with the absorption of approximately 1/3 of the fat eaten in the diet. Xenical appears to be effective for reducing weight and obesity-associated diseases in obese adults. Researchers propose to determine the safety, tolerability, and efficacy of Xenical in 12-17 year old severely obese African American and Caucasian children and adolescents who have one or more obesity-related disease (hypertension, hyperlipidemia, sleep apnea, hepatic steatosis, insulin resistance, impaired glucose tolerance, or Type 2 diabetes).
NCT00108524 A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss Completed VA Office of Research and Development N/A This study compares two types of diet interventions: a low carbohydrate ketogenic diet (Atkins) and a low-fat diet combined with a medication (Orlistat).
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Xenical

Condition Name

Condition Name for Xenical
Intervention Trials
Obesity 12
Hepatitis C 2
Fatty Liver 2
Diabetes Mellitus 2
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Condition MeSH

Condition MeSH for Xenical
Intervention Trials
Obesity 7
Weight Loss 4
Hepatitis 2
Overweight 2
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Clinical Trial Locations for Xenical

Trials by Country

Trials by Country for Xenical
Location Trials
United States 8
Canada 1
Brazil 1
Iran, Islamic Republic of 1
Switzerland 1
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Trials by US State

Trials by US State for Xenical
Location Trials
Texas 2
Louisiana 1
Pennsylvania 1
Connecticut 1
Missouri 1
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Clinical Trial Progress for Xenical

Clinical Trial Phase

Clinical Trial Phase for Xenical
Clinical Trial Phase Trials
Phase 4 8
Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Xenical
Clinical Trial Phase Trials
Completed 12
Unknown status 2
Withdrawn 1
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Clinical Trial Sponsors for Xenical

Sponsor Name

Sponsor Name for Xenical
Sponsor Trials
Hoffmann-La Roche 4
Donaghue Medical Research Foundation 1
Germed Pharma 1
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Sponsor Type

Sponsor Type for Xenical
Sponsor Trials
Other 12
Industry 7
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Cerilliant
AstraZeneca
Accenture
Medtronic
Argus Health
Federal Trade Commission
Teva
Johnson and Johnson

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