CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 89 enrolled
Drug / intervention
SHP465 +1 moredrug
Likely dose
SHP465 6.25 mgfrom 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.

Search/NCT03325881
NCT03325881Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Fixed-Dose, Efficacy, and Safety Study of SHP465 in Children Aged 6-12 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)

Shire·interventional·Posted Oct 30, 2017·Updated Jun 2, 2021

In Brief

A Phase 3 clinical trial evaluating SHP465 and Placebo for Attention Deficit Hyperactivity Disorder (ADHD). Completed, enrolled 89 participants across 41 sites.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of SHP465 at 6.25 mg in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6-12 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder (ADHD)
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedOct 30, 2017
Enrollment StartDec 9, 2017
Primary CompletionJun 7, 2018
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 8.7 years ago

Interventions

SHP465drug

SHP465 capsule 6.25 mg orally once daily for 4 weeks

Placebodrug

Placebo matching to SHP465 capsule orally once daily for 4 weeks