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

Brief Summary

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).

  • Study Type: Interventional
  • Study Design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: March 2010

Interventions Used 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)

Outcome Measures for this Clinical Trial

Primary Measures

  • Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])
    • Time Frame: 1 year
      Safety Issue?: Yes
  • Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])
    • Time Frame: 1 year
      Safety Issue?: Yes
  • Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett’s (QTcB) at Week 4
    • Time Frame: At baseline and at Week 4
      Safety Issue?: Yes
  • Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12
    • Time Frame: At baseline and at weeks 1, 2, 3, 4, and months 2, 3, 4, 5, 6, 9, and 12
      Safety Issue?: Yes
  • Change From Baseline in Diastolic Blood Pressure at Week 4
    • Time Frame: At baseline and at Week 4
      Safety Issue?: Yes
  • Change From Baseline in Systolic Blood Pressure at Week 4
    • Time Frame: At baseline and at Week 4
      Safety Issue?: Yes
  • Change From Baseline in Body Temperature at Week 4
    • Time Frame: At baseline and at Week 4
      Safety Issue?: Yes
  • Change From Baseline in Heart Rate at Week 4
    • Time Frame: At baseline and at Week 4
      Safety Issue?: Yes
  • Change From Baseline in 12-lead Electrocardiogram in Terms of Heart Rate at Week 4
    • Time Frame: At baseline and at Week 4
      Safety Issue?: Yes

Secondary Measures

  • Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12
    • Time Frame: At baseline, months 1, 2, 3, 4, 6, 9, and 12
      Safety Issue?: No
  • Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12
    • Time Frame: At baseline, months 1, 2, 3, 4, 6, 9, and 12
      Safety Issue?: No
  • Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12
    • Time Frame: At baseline, months 1, 2, 3, 4, 6, 9, and 12
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

  • Lead Sponsor
    • Shionogi
  • Provider of Information About this Clinical Study
    • Shionogi Clinical Trials Administrator, Shionogi
  • Overall Official(s)
    • Shionogi Clinical Trials Administrator Clinical Support Help Line, Study Director, Shionogi

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00723190