The purpose of this study is to determine whether CLONICEL® (clonidine HCl sustained release) is a safe and effective treatment for children and adolescents with attention deficit hyperactivity disorder (ADHD).
Clonidine is a centrally acting alpha2 adrenergic agonist that has been used effectively since the early 70s to treat mild to moderate hypertension. In addition to hypertension, clonidine has been evaluated and used extensively for several other indications, including attention deficit hyperactivity disorder (ADHD). An easy to administer clonidine formulation is needed that retains the efficacy of the current oral formulation but has an improved safety profile. The current trial will investigate the safety and efficacy of clonidine delivered from the sustained release formulation of CLONICEL in the treatment of children and adolescents with ADHD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
236
high dose clonidine HCl sustained release tablets for 8 weeks
low dose clonidine HCl sustained release tablets for 8 weeks
placebo tablets for 8 weeks
Unnamed facility
Gainesville, Florida, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Miami, Florida, United States
ADHDRS-IV
Time frame: Week 5
CPRS-L, CGI-S, and CGI-I
Time frame: Week 5
Adverse Events, Laboratory Assessments, Vital Signs, and ECGs
Time frame: Throughout Treatment Phase
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Unnamed facility
Orlando, Florida, United States
Unnamed facility
Rochester Hills, Michigan, United States
Unnamed facility
Clementon, New Jersey, United States
Unnamed facility
Voorhees Township, New Jersey, United States
Unnamed facility
Chapel Hill, North Carolina, United States
Unnamed facility
Charlotte, North Carolina, United States
Unnamed facility
Oklahoma City, Oklahoma, United States
...and 3 more locations