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NCT00507065 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of ADDERALL XR in the Treatment of Adolescents Aged 13-17 With Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 329
- Enrollment target
NCT00507065 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 329 participants.
The verdict
NCT00507065, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 329 participants
- Enrollment target
Study Summary
Assess the safety and efficacy of ADDERALL XR compared to placebo in the treatment of adolescents (aged 13-17) with ADHD. Subjects were assigned to one of two cohorts based on weight (\<= 75 kg or \> 75 kg).
Interventions
- DRUG Placebo
- DRUG Mixed salts of a single-entity amphetamine (ADDERALL XR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 329 participants |
| Start Date | 2003-05-28 |
| Est. Completion | 2004-03-24 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00507065
The ClinicalTrials.gov registry entry for NCT00507065 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 329 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.
NCT00507065 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00507065 about?
NCT00507065 is a clinical study titled "Safety and Efficacy of ADDERALL XR in the Treatment of Adolescents Aged 13-17 With Attention Deficit Hyperactivity Disorder (ADHD)". Assess the safety and efficacy of ADDERALL XR compared to placebo in the treatment of adolescents (aged 13-17) with ADHD. Subjects were assigned to one of two cohorts based on weight (\<= 75 kg or \> 75 kg).
What is the current status of trial NCT00507065?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 329 participants. The study started on 2003-05-28. Estimated completion is 2004-03-24.
What interventions are being tested in trial NCT00507065?
The interventions under investigation include: Placebo (DRUG), Mixed salts of a single-entity amphetamine (ADDERALL XR) (DRUG).
Who is sponsoring clinical trial NCT00507065?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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