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The Safety and Efficacy of OPC-64005 in the Treatment of Adult Attention-deficit/Hyperactivity Disorder

NCT03324581 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2021-10-29

Study results available
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Summary

A trial to assess the safety and efficacy of OPC-64005 in the treatment of adult attention-deficit/hyperactivity disorder.

Conditions

  • Adult Attention Deficit Hyperactivity Disorder

Interventions

DRUG

OPC-64005

OPC-64005 film coated tablets

DRUG

Atomoxetine

Atomoxetine gelatin capsules

DRUG

Placebo

OPC-64005-matching placebo film coated tablets and atomoxetine-matching placebo gelatin capsules

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-11-09
Primary Completion
2018-10-31
Completion
2018-10-31
FDA Drug
Yes

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 NCT03324581 on ClinicalTrials.gov