drugset
drugset / Trial / NCT03324581

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

NCT03324581 ↗

Phase 2 Completed 239 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

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

Timeline

Start
2017-11-09
Primary completion
2018-10-31
Completion
2018-10-31

Outcome

Met primary endpoint

registry analysis (superiority test); OPC-64005 vs Placebo; p =0.0101; Difference -6.61 (95% CI -11.6 to -1.60) NCT03324581 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Atomoxetine Other / unclassified 80 mg Oral
Subject OPC-64005 Unknown 30 mg Oral

Indications

attention deficit-hyperactivity disorder