MedTrace Logo

Safety and Efficacy Study of SHP465 in Children and Adolescents Aged 6-17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)

NCT02466425 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2021-06-03

Study results available
· View outcomes & findings →

Summary

The study is designed to evaluate the efficacy and safety of SHP465 in the treatment of ADHD in children and adolescents (aged 6-17 years). The primary objective of this study is to evaluate the efficacy of SHP465 administered as a daily morning dose compared to placebo in the treatment of children and adolescents (6-17 years of age inclusive) diagnosed with ADHD.

Conditions

  • Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

DRUG

SHP465

12.5mg and 25mg capsules (one capsule daily)

DRUG

Placebo

Matching placebo capsule that appear identical in size, weight, shape, color

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-18
Primary Completion
2016-02-16
Completion
2016-02-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02466425 on ClinicalTrials.gov