Trials / Completed
CompletedNCT00764868
Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study
A Phase III, Open-Label, Extension, Multi-Center, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Adolescents Aged 13-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 269 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 13 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the long-term safety of LDX administered as a daily morning dose (30, 50, and 70 mg/day) in the treatment of adolescents (13-17 years of age inclusive at the time of consent).
Detailed description
Not Required
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lisdexamfetamine Dimesylate (LDX) | optimal dose of 30, 50 or 70 mg once daily |
Timeline
- Start date
- 2008-11-13
- Primary completion
- 2010-04-22
- Completion
- 2010-04-22
- First posted
- 2008-10-02
- Last updated
- 2021-06-14
- Results posted
- 2011-03-28
Locations
45 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00764868. Inclusion in this directory is not an endorsement.