Trials / Completed
CompletedNCT00507065
Safety and Efficacy of ADDERALL XR in the Treatment of Adolescents Aged 13-17 With Attention Deficit Hyperactivity Disorder (ADHD)
A Phase III, Randomized, Multicenter, Double-blind, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of ADDERALL XR With an Open Label Extension, in the Treatment of Adolescents Aged 13-17 With ADHD
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 329 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 13 Years – 17 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mixed salts of a single-entity amphetamine (ADDERALL XR) | |
| DRUG | Placebo |
Timeline
- Start date
- 2003-05-28
- Primary completion
- 2004-03-24
- Completion
- 2004-03-24
- First posted
- 2007-07-25
- Last updated
- 2021-06-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00507065. Inclusion in this directory is not an endorsement.