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NCT00877487 · ClinicalTrials.gov registry record · Phase 4
Safety and Efficacy of Vyvanse in Adults With Attention-Deficit/Hyperactivity Disorder
A Phase 4 study, sponsored by Shire.
- Completed
- Registry status
- Phase 4
- Development phase
- 123
- Enrollment target
NCT00877487 is a Phase 4 study that has completed, run by Shire. The registered enrollment target is 123 participants.
The verdict
NCT00877487, a Phase 4 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 123 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the maintenance of efficacy, as measured by Adult ADHD Rating Scale with Prompts (Adult ADHD-RS with prompts) and Clinical Global Impression - Severity (CGI-S) scores, through a randomized withdrawal design when subjects with ADHD have been on stable treatment with commercial SPD489 for a minimum of 6 months and are maintained on their screening dose of commercial SPD489.
Interventions
- DRUG Placebo
- DRUG SPD489 (Lisdexamfetamine dimesylate)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2009-04-30 |
| Est. Completion | 2010-07-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00877487
The ClinicalTrials.gov registry entry for NCT00877487 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00877487 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00877487 about?
NCT00877487 is a clinical study titled "Safety and Efficacy of Vyvanse in Adults With Attention-Deficit/Hyperactivity Disorder". The primary objective of this study is to evaluate the maintenance of efficacy, as measured by Adult ADHD Rating Scale with Prompts (Adult ADHD-RS with prompts) and Clinical Global Impression - Severity (CGI-S) scores, through a randomized withdrawal design when subjects with ADHD have been on stabl...
What is the current status of trial NCT00877487?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 123 participants. The study started on 2009-04-30. Estimated completion is 2010-07-08.
What interventions are being tested in trial NCT00877487?
The interventions under investigation include: Placebo (DRUG), SPD489 (Lisdexamfetamine dimesylate) (DRUG).
Who is sponsoring clinical trial NCT00877487?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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