NCT03324581

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

A Phase 2, Multicenter, Randomized, Double-blind, Active- and Placebo-controlled Trial of the Safety and Efficacy of OPC-64005 in the Treatment of Adult Attention-deficit/Hyperactivity Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

A multicenter, randomized, double-blind, active- and placebo-controlled, parallel-design trial.

Conditions

• Adult Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-11-09
• Primary completion: 2018-10-31
• Completion: 2018-10-31
• First posted: 2017-10-27
• Last updated: 2021-10-29
• Results posted: 2021-10-29

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study