At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 275 enrolled
Drug / intervention
SHP465 12.5mg capsules (one capsule daily) +2 moredrug
Likely dose
SHP465 12.5mg capsules (one capsule daily)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating SHP465 12.5mg capsules (one capsule daily), Placebo, and 1 other intervention for Attention Deficit Hyperactivity Disorder (ADHD). Completed, enrolled 275 participants across 45 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 2015
Enrollment StartNov 2015
Primary CompletionMar 2016
TodayJul 2026
First PostedNov 13, 2015
Enrollment StartNov 19, 2015
Primary CompletionMar 24, 2016
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 10.6 years ago
Interventions
SHP465 12.5mg capsules (one capsule daily)drug
one capsule daily
Placeboother
Matching placebo capsule that appears identical in size, weight, shape, and color (one capsule daily)
SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily)drug
One capsule daily