Open-Label, Chronic Exposure, Safety Study of CLONICEL (Clonidine HCl Sustained Release) in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
NCT ID: NCT00723190
Last Updated: 2018-04-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
303 participants
INTERVENTIONAL
2008-01-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm A
CLONICEL (Clonidine HCl sustained release)
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
Interventions
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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 Criteria
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Inclusion Criteria
* 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
* 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.
6 Years
17 Years
ALL
No
Sponsors
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Shionogi
INDUSTRY
Responsible Party
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Shionogi
Principal Investigators
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Shionogi Clinical Trials Administrator Clinical Support Help Line
Role: STUDY_DIRECTOR
Shionogi
Locations
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Little Rock, Arkansas, United States
El Centro, California, United States
Irvine, California, United States
San Diego, California, United States
Bradenton, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Lauderhill, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Bardstown, Kentucky, United States
Baltimore, Maryland, United States
Rochester Hills, Michigan, United States
St Louis, Missouri, United States
Voorhees Township, New Jersey, United States
Willingboro, New Jersey, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Houston, Texas, United States
Lake Jackson, Texas, United States
Wharton, Texas, United States
Clinton, Utah, United States
Kirkland, Washington, United States
Countries
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Other Identifiers
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CLON-303
Identifier Type: -
Identifier Source: org_study_id
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