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

This study has been completed.
Sponsor:
Information provided by:
Shionogi Inc.
ClinicalTrials.gov Identifier:
NCT00723190
First received: July 24, 2008
Last updated: January 24, 2012
Last verified: September 2011
  Purpose

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).


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: CLONICEL (Clonidine HCl sustained release)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Shionogi Inc.:

Primary Outcome Measures:
  • Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Safety assessments were performed at each study visit according to the time and events schedule. All safety analyses were based on safety population

  • Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Safety assessments were performed at each study visit according to the time and events schedule. All safety analysis were based on safety population

  • 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 ] [ Designated as 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 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Diastolic Blood Pressure at Week 4 [ Time Frame: At baseline and at Week 4 ] [ Designated as safety issue: Yes ]
    Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement

  • Change From Baseline in Systolic Blood Pressure at Week 4 [ Time Frame: At baseline and at Week 4 ] [ Designated as safety issue: Yes ]
    Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement

  • Change From Baseline in Body Temperature at Week 4 [ Time Frame: At baseline and at Week 4 ] [ Designated as safety issue: Yes ]
    Temperature was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement

  • Change From Baseline in Heart Rate at Week 4 [ Time Frame: At baseline and at Week 4 ] [ Designated as safety issue: Yes ]
    Heart rate was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement

  • Change From Baseline in 12-lead Electrocardiogram in Terms of Heart Rate at Week 4 [ Time Frame: At baseline and at Week 4 ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]
    The ADHDRS-IV consists of 18 items designed to reflect symptoms of ADHD. Each item is scored on a scale of 0 (Never or rarely) to 3 (Very Often). The subscales of the ADHDRS-IV included the Inattention and the hyperactivity/Impulsivity subscales (total possible score range, 0-54). The Inattention subscale consists of the sum of 9 items: 1, 3, 5, 7, 9, 11, 13, 15, and 17. The Hyperactivity/Impulsivity subscale consists of the sum of 9 items: 2, 4, 6, 8, 10, 12, 14, 16, and 18

  • 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 ] [ Designated as safety issue: No ]

    CGI-S scale:

    1 = Normal, not ill at all; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients


  • 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 ] [ Designated as safety issue: No ]

    CGI-I scale:

    1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse



Enrollment: 303
Study Start Date: January 2008
Study Completion Date: June 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
CLONICEL (Clonidine HCl sustained release)
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

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723190

  Show 27 Study Locations
Sponsors and Collaborators
Shionogi
Investigators
Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line Shionogi
  More Information

No publications provided

Responsible Party: Shionogi Clinical Trials Administrator, Shionogi
ClinicalTrials.gov Identifier: NCT00723190     History of Changes
Other Study ID Numbers: CLON-303
Study First Received: July 24, 2008
Results First Received: September 20, 2011
Last Updated: January 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Shionogi Inc.:
CLONICEL
Attention Deficit Hyperactivity Disorder
clonidine HCl sustained release
attention deficit hyperactivity disorder

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Clonidine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 29, 2014