Study Evaluating the Safety and Efficacy of CLONICEL® to Treat Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

Phase 3 Completed 236 enrolled Addrenex Pharmaceuticals, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether CLONICEL® (clonidine HCl sustained release) is a safe and effective treatment for children and adolescents with attention deficit hyperactivity disorder (ADHD).

Timeline

Start: 2007-10
Primary completion: 2008-08
Completion: 2008-08

Outcome

Met primary endpoint

paper Improvement from baseline in ADHD-RS-IV total score was significantly greater in both CLON-XR groups versus placebo at week 5. PMID 21241954 ↗

Publications

Jain R, Segal S, Kollins SH, Khayrallah M. Clonidine extended-release tablets for pediatric patients with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2011 Feb;50(2):171-9. doi: 10.1016/j.jaac.2010.11.005.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Clonidine	Other / unclassified	0.2 mg	Oral
Subject	Clonidine	Other / unclassified	0.4 mg	Oral