Trials / Completed
CompletedNCT02604407
Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Forced-dose Titration, Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 275 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
The study is designed to evaluate the efficacy and safety of each dose of SHP465 (12.5 and 37.5 mg) given to participants daily in the morning compared to placebo in the treatment of adults aged 18 to 55 years diagnosed with ADHD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHP465 12.5mg capsules (one capsule daily) | one capsule daily |
| OTHER | Placebo | Matching placebo capsule that appears identical in size, weight, shape, and color (one capsule daily) |
| DRUG | SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily) | One capsule daily |
Timeline
- Start date
- 2015-11-19
- Primary completion
- 2016-03-24
- Completion
- 2016-03-24
- First posted
- 2015-11-13
- Last updated
- 2021-06-03
- Results posted
- 2017-06-14
Locations
45 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02604407. Inclusion in this directory is not an endorsement.