Trials / Completed
CompletedNCT00784654
Double-blind, Placebo-controlled, Randomised Withdrawal, Extension, Safety and Efficacy Study of LDX in Children and Adolescents Aged 6-17
A Phase III, Double-blind, Placebo-controlled, Randomised Withdrawal, Multicentre, Extension, 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
- 276 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The main aim of this study is to evaluate the long-term maintenance of efficacy of LDX after administered to children and adolescents aged 6-17 with ADHD for at least 6 months
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lisdexamfetamine dimesylate (LDX) | LDX 30, 50, or 70mg capsule once per day (open-label and double-blind periods) |
| DRUG | Placebo | Placebo capsule once per day (double-blind period) |
Timeline
- Start date
- 2009-01-27
- Primary completion
- 2011-10-26
- Completion
- 2011-10-26
- First posted
- 2008-11-04
- Last updated
- 2021-06-09
- Results posted
- 2012-10-02
Locations
51 sites across 9 countries: United States, Belgium, France, Germany, Hungary, Italy, Poland, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT00784654. Inclusion in this directory is not an endorsement.