Open-Label, Chronic Exposure, Safety Study of CLONICEL (Clonidine HCl Sustained Release) in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: CLONICEL (Clonidine HCl sustained release)
Intervention description: 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
Intervention MeSH terms: Clonidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 303.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: CLONICEL; Attention Deficit Hyperactivity Disorder; clonidine HCl sustained release

Summary:

      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).
    

Eligibility criteria:

        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.