Clinical trial NCT00723190: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: CLONICEL
Attention Deficit Hyperactivity Disorder
clonidine HCl sustained release
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-28
Enrollment: 303
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])
timeFrame: 1 year
measure: Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])
timeFrame: 1 year
measure: Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett's (QTcB) at Week 4
timeFrame: At baseline and at Week 4
measure: Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12
timeFrame: At baseline and at weeks 1, 2, 3, 4, and months 2, 3, 4, 5, 6, 9, and 12
measure: Change From Baseline in Diastolic Blood Pressure at Week 4
timeFrame: At baseline and at Week 4
measure: Change From Baseline in Systolic Blood Pressure at Week 4
timeFrame: At baseline and at Week 4
measure: Change From Baseline in Body Temperature at Week 4
timeFrame: At baseline and at Week 4
measure: Change From Baseline in Heart Rate at Week 4
timeFrame: At baseline and at Week 4
measure: Change From Baseline in 12-lead Electrocardiogram in Terms of Heart Rate at Week 4
timeFrame: At baseline and at Week 4
Secondary outcomes:
measure: 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
timeFrame: At baseline, months 1, 2, 3, 4, 6, 9, and 12
measure: Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12
timeFrame: At baseline, months 1, 2, 3, 4, 6, 9, and 12
measure: Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12
timeFrame: At baseline, months 1, 2, 3, 4, 6, 9, and 12
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: El Centro
country: United States
state: California
city: Irvine
country: United States
state: California
city: San Diego
country: United States
state: California
city: Bradenton
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Lauderhill
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Bardstown
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Rochester Hills
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: Voorhees
country: United States
state: New Jersey
city: Willingboro
country: United States
state: New Jersey
city: Chapel Hill
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Houston
country: United States
state: Texas
city: Lake Jackson
country: United States
state: Texas
city: Wharton
country: United States
state: Texas
city: Clinton
country: United States
state: Utah
city: Kirkland
country: United States
state: Washington
Study officials:
affiliation: Shionogi
name: Shionogi Clinical Trials Administrator Clinical Support Help Line
role: STUDY_DIRECTOR
References: