Clinical Trial: Study Evaluating the Safety and Efficacy of CLONICEL® to Treat Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase III, Dose-Response Evaluation of the Efficacy and Safety of CLONICEL® (Clonidine HCl Sustained Release) vs. Placebo in the Treatment of Children and Adolescents With
Brief 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).
Detailed Summary:
Clonidine is a centrally acting alpha2 adrenergic agonist that has been used effectively since the early 70s to treat mild to moderate hypertension. In addition to hypertension, clonidine has been evaluated and used extensively for several other indications, including attention deficit hyperactivity disorder (ADHD).
An easy to administer clonidine formulation is needed that retains the efficacy of the current oral formulation but has an improved safety profile. The current trial will investigate the safety and efficacy of clonidine delivered from the sustained release formulation of CLONICEL in the treatment of children and adolescents with ADHD.
Sponsor: Addrenex Pharmaceuticals, Inc.
Current Primary Outcome: ADHDRS-IV [ Time Frame: Week 5 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- CPRS-L, CGI-S, and CGI-I [ Time Frame: Week 5 ]
- Adverse Events, Laboratory Assessments, Vital Signs, and ECGs [ Time Frame: Throughout Treatment Phase ]
Original Secondary Outcome: Same as current
Information By: Addrenex Pharmaceuticals, Inc.
Dates:
Date Received: November 8, 2007
Date Started: October 2007
Date Completion:
Last Updated: March 23, 2010
Last Verified: August 2008
