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NCT01017263 · ClinicalTrials.gov registry record · Phase 4

Vyvanse and Glucose Intolerance in Children With Attention Deficit Hyperactivity Disorder (ADHD) and Obesity

A Phase 4 study, sponsored by Duke University.

Terminated
Registry status
Phase 4
Development phase
14
Enrollment target

NCT01017263: Clinical Trial Phase 4 study, sponsored by Duke University.

NCT01017263 is a Phase 4 study that was terminated before completion, run by Duke University. The registered enrollment target is 14 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01017263, a Phase 4 study, was terminated before completion, sponsored by Duke University.

TERMINATED
Registry status
Phase 4
Development phase
14 participants
Enrollment target

Study 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.

Primary Outcome

The study was terminated due to lack of enrollment therefore outcome measures were not assessed. If completed, the expected outcomes would have shown an improvement of the subject's fasting and 2 hour post prandial glucose values, insulin levels and HbA1c. However, all of the subjects recruited did not have abnormal values to start with. The two subjects who were enrolled were the younger kids to which the entry lab criteria do not apply.

Interventions

  • DRUG Lis-dexamphetamine

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2009-12
Est. Completion 2012-08
Phase Phase 4
Duke University

1,725 total trials

Why NCT01017263 stopped before completion

NCT01017263 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Lis-dexamphetamine is the first listed.

NCT01017263 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01017263 about?

NCT01017263 is a clinical study titled "Vyvanse and Glucose Intolerance in Children With Attention Deficit Hyperactivity Disorder (ADHD) and Obesity". 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.

What is the current status of trial NCT01017263?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2009-12. Estimated completion is 2012-08.

What interventions are being tested in trial NCT01017263?

The interventions under investigation include: Lis-dexamphetamine (DRUG).

Who is sponsoring clinical trial NCT01017263?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01017263's enrollment target sits among peer trials

14 1901st of 2000 higher than 91 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01017263, the US trial registry maintained by the National Library of Medicine. NCT01017263 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.