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Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)

NCT02604407 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2021-06-03

Study results available
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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

  • Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

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

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-19
Primary Completion
2016-03-24
Completion
2016-03-24

Countries

  • United States

Study Locations

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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 NCT02604407 on ClinicalTrials.gov