Vyvanse and Glucose Intolerance in Children With Attention Deficit Hyperactivity Disorder (ADHD) and Obesity
This study has been terminated.
(Due very high screen fail rate, pre study feasibility not consistent with screened population.)
Sponsor:
Duke University
Collaborator:
Shire Development LLC
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01017263
First received: November 19, 2009
Last updated: November 16, 2012
Last verified: November 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 19, 2009 | ||||
| Last Updated Date | November 16, 2012 | ||||
| Start Date ICMJE | December 2009 | ||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Fasting and 2 hour post prandial glucose, insulin and HbA1c. [ Time Frame: Screening, Visit 7 and 11(end of study) ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01017263 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Vyvanse and Glucose Intolerance in Children With Attention Deficit Hyperactivity Disorder (ADHD) and Obesity | ||||
| Official Title ICMJE | Vyvanse and Glucose Intolerance in Children With ADHD and Obesity | ||||
| Brief Summary | The purpose of this study to assess the effects of chronic administration of Vyvanse (lis-dexamphetamine) on glucose metabolism in a sample of children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who also have glucose intolerance and are obese. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Lis-dexamphetamine
Lis-dexamphetamine starting at 20mg once a day dose, increased weekly by 10mg increments up to a maximum dose of 70mg.
Other Name: Vyvanse, LDX |
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| Study Arm (s) | Active Comparator: Open label Vyvanse
All subjects receive Vyvanse.
Intervention: Drug: Lis-dexamphetamine |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 2 | ||||
| Completion Date | August 2012 | ||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 8 Years to 17 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01017263 | ||||
| Other Study ID Numbers ICMJE | Pro00019063 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Duke University | ||||
| Study Sponsor ICMJE | Duke University | ||||
| Collaborators ICMJE | Shire Development LLC | ||||
| Investigators ICMJE |
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| Information Provided By | Duke University | ||||
| Verification Date | November 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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