drugset
drugset / Trial / NCT01323192

An Efficacy and Safety Study for JNS001 in Adults With Attention-Deficit Hyperactivity Disorder

NCT01323192 ↗

Phase 3 Completed 284 enrolled Janssen Pharmaceutical K.K.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The main purpose of this study is to evaluate the efficacy of JNS001 titrated to daily doses of 18 to 72 mg in adults with attention-deficit hyperactivity disorder (ADHD) relative to placebo.

Timeline

Start
2011-03
Primary completion
2012-04
Completion
2012-04

Outcome

Met primary endpoint

registry analysis (superiority or other test); JNS001 vs Placebo; p <0.0001; Difference in least square means -4.5 (95% CI -6.7 to -2.4); ANCOVA NCT01323192 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject JNS001 Unknown 18 mg Oral
Subject JNS001 Unknown 36 mg Oral
Subject JNS001 Unknown 54 mg Oral
Subject JNS001 Unknown 72 mg Oral

Indications

attention deficit-hyperactivity disorder