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NCT01106430 · ClinicalTrials.gov registry record · Phase 3
Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 267
- Enrollment target
NCT01106430: Completed Phase 3 study, sponsored by Shire.
NCT01106430 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 267 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01106430, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 267 participants
- Enrollment target
Study Summary
This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate therapy. The study will also test the safety of Lisdexamfetamine Dimesylate and how well it works.
Primary Outcome
Time to first response was defined as a Clinical Global Impression-Improvement (CGI-I) value of 1 (very much improved) or 2 (much improved) first recorded following first dose of investigational product. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Interventions
- DRUG Lisdexamfetamine Dimesylate
- DRUG Atomoxetine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 267 participants |
| Start Date | 2010-06-28 |
| Est. Completion | 2012-07-19 |
| Phase | Phase 3 |
What the finished NCT01106430 record still lists
NCT01106430 is an interventional study that assigns participants to a tested intervention. The registered 267 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Lisdexamfetamine Dimesylate is the first listed.
NCT01106430 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01106430 about?
NCT01106430 is a clinical study titled "Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate". This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate therapy. The study will also test the safety of Lisdexamfetamine Dimesylate and how well it works.
What is the current status of trial NCT01106430?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 267 participants. The study started on 2010-06-28. Estimated completion is 2012-07-19.
What interventions are being tested in trial NCT01106430?
The interventions under investigation include: Lisdexamfetamine Dimesylate (DRUG), Atomoxetine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01106430?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01106430's enrollment target sits among peer trials
267 1222nd of 2000 higher than 779 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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