Open-Label, Chronic Exposure, Safety Study of CLONICEL (Clonidine HCl Sustained Release) in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

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 12-month, multi-center, open-label study is to evaluate the safety of CLONICEL (clonidine HCl sustained release) when administered chronically under regular clinical conditions either as monotherapy or in combination with stimulant therapy to children and adolescents with attention deficit hyperactivity disorder (ADHD).

Intervention(s) in this Clinical Trial

• Drug: CLONICEL (Clonidine HCl sustained release)
  • 0.1 mg for 1 week; the dose may be escalated to 0.2 mg/day at week 2, 0.3 mg/day at week 3, and 0.4 mg/day at week 4

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm A
  • CLONICEL (Clonidine HCl sustained release)

Primary Measures

• Safety assessments include recording of adverse events, vital signs (blood pressure, heart rate, and body temperature), weight, 12-lead electrocardiograms, and update on concomitant medication usage
  • Time Frame: Throughout the treatment phase
    Safety Issue?: Yes

Secondary Measures

• Efficacy assessment include ADHD rating scale (ADHDRS-IV Scale), Clinical Global Impressions-Severity (CGI-S), and Clinical Global Impressions-Improvement (CGI-I) with comparison to the Baseline visit
  • Time Frame: Month 1 (Week 4), 2, 3, 4, 6, 9, and 12 visits
    Safety Issue?: No

Inclusion Criteria:

• Male or female subject who has completed either study CLON-301 or study CLON-302, or discontinued early for reasons other than adverse events necessitating discontinuation
• Age between 6 and 17 years, inclusive
• Diagnosis of attention deficit hyperactivity disorder of the hyperactive or combined inattentive/hyperactive subtypes according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV) criteria
• General good health as judged by the Principal Investigator
• Body mass index (BMI) ≥ 5th percentile of the subject's age group according to the CDC growth chart. BMI is calculated using the formula: weight (kg) / [height (m)]2
• Subject as well as parent/guardian able to sign informed assent or consent form

Exclusion Criteria:

• If female of child-bearing potential, pregnant or lactating or does not agree to use a medically acceptable form of birth control, such as hormonal medication, double-barrier method, or intrauterine device
• Presence of a clinically significant illness or abnormality on physical examination or clinical laboratory evaluations that, in the opinion of the investigator, would increase the safety risks from clonidine administration or interfere with the ability of the patient to take part in the study.
• Presence of clinically significant abnormality on centrally interpreted electrocardiogram readings
• History or presence of a concomitant psychiatric disorder requiring psychotropic medication or a severe concomitant axis I or axis II disorder that could interfere with study assessments in the judgment of the Principal Investigator
• 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 Investigator: Shionogi Industry

Overall Clinical Trial Officials and Contacts

Shionogi Clinical Trials Administrator Clinical Support Help Line Study Director Shionogi  

Information obtained from ClinicalTrials.gov on February 09, 2012

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