Official Title: “An Open-Label, Chronic Exposure Evaluation of the Safety of CLONICEL (Clonidine HCl Sustained Release) in the Treatment of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)”

The purpose of this study is to evaluate the safety of CLONICEL (clonidine HCl sustained release) when administered chronically under regular clinical conditions to children and adolescents with attention deficit hyperactivity disorder (ADHD).

Study Type: Interventional

Study Design: Treatment, Open Label, Single Group Assignment, Safety Study

Study Primary Completion Date: January 2010

Intervention(s) in this Clinical Trial

• Drug: CLONICEL (Clonidine HCl Sustained Release)
  • Flexible Dose

Primary Measures

• Treatment Emergent Adverse Events
  • Time Frame: Throughout Treatment Phase
    Safety Issue?: Yes

Secondary Measures

• Changes in Vital Signs, Laboratory Assessments, and ECGs
  • Time Frame: From Baseline to End of Treatment or Early Discontinuation
    Safety Issue?: Yes
• Changes in ADHDRS-IV, CGI-S, and CGI-I ratings
  • Time Frame: From Baseline to End of Treatment or Early Discontinuation
    Safety Issue?: No

Inclusion Criteria:

• Completed Study CLON-301 or CLON-302, or discontinued early for reasons other than adverse events necessitating discontinuation
• Diagnosis of ADHD
• In general good health

Exclusion Criteria:

• Clinically significant illnesses or abnormalities upon evaluation
• History or presence of a concomitant psychiatric disorder currently requiring psychotropic medication
• Presence of a disorder that would interfere with the absorption, metabolism, or excretion of clonidine
• Presence of alcohol or drug abuse

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Addrenex Pharmaceuticals, Inc.

Overall Clinical Trial Officials and Contacts

Moise Khayrallah, PhD Study Director Addrenex Pharmaceuticals, Inc.  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00723190

Study ID Number: CLON-303

ClinicalTrials.gov Identifier: NCT00723190

Health Authority: United States: Food and Drug Administration

Addrenex Pharmaceuticals