Trials / Completed
CompletedNCT00763971
Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17
A Phase III, Randomised, Double-Blind, Multicentre, Parallel-Group, Placebo- and Active-Controlled, Dose-Optimisation Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 336 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lisdexamfetamine Dimesylate (LDX) | 30, 50 or 70mg capsule once per day (Overencapsulated) |
| DRUG | Methylphenidate Hydrochloride | 18, 36, or 54mg tablet one per day (Overencapsulated) |
| DRUG | Placebo | Placebo capsule once per day (Overencapsulated) |
Timeline
- Start date
- 2008-11-17
- Primary completion
- 2011-03-16
- Completion
- 2011-03-16
- First posted
- 2008-10-01
- Last updated
- 2021-06-14
- Results posted
- 2012-03-22
Locations
49 sites across 10 countries: Belgium, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT00763971. Inclusion in this directory is not an endorsement.