Trials / Terminated
TerminatedNCT03325894
Safety and Tolerability Study of SHP465 in Children Aged 4 to 12 Years Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD)
A Phase 3, Open-label, Multicenter, 12-Month Safety and Tolerability Study of SHP465 in Children Aged 4 to 12 Years Diagnosed With Attention-deficit/Hyperactivity Disorder
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 141 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 4 Years – 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the long-term safety and tolerability of SHP465 at 6.25 milligram (mg) in children aged 4 to 12 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHP465 | SHP465 capsule will be administered in a dose of 6.25 mg orally once daily for 360 days. |
Timeline
- Start date
- 2018-01-02
- Primary completion
- 2019-01-19
- Completion
- 2019-01-19
- First posted
- 2017-10-30
- Last updated
- 2021-06-03
- Results posted
- 2020-02-05
Locations
48 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03325894. Inclusion in this directory is not an endorsement.