CLONICEL (Clonidine Sustained Release) as Add-on to Stimulant Medication in 6 to 17 Yr-olds With ADHD

Completed · Phase 3 · Has a placebo group

Conditions studied: ADHD

In brief

The purpose of this study is to determine if CLONICEL (clonidine HCl sustained release) is a safe and effective add-on to psychostimulant therapy in children and adolescents with attention deficit hyperactivity disorder (ADHD).

Key facts

Study ID

NCT00641329

Run by

Addrenex Pharmaceuticals, Inc.

People needed

198

Starts

2008-02-01

Expected to finish

2009-02-01

Last updated by the study team

2010-04-09

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 6-17 years, inclusive
• Diagnosis of ADHD
• Currently on a stable psychostimulant regimen for ADHD
• Lack of adequate response to stable psychostimulant regimen
• Ability to swallow tablets

You may not qualify if…

• Clinically significant illnesses or abnormalities upon evaluation
• Conduct Disorder
• Intolerance to clonidine
• History of seizures or syncope

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — El Centro, California, United States
• Study site — Irvine, California, United States
• Study site — San Diego, California, United States
• Study site — Bradenton, Florida, United States
• Study site — Lauderhill, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Bardstown, Kentucky, United States
• Study site — Baltimore, Maryland, United States
• Study site — St Louis, Missouri, United States
• Study site — Clementon, New Jersey, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Houston, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Lake Jackson, Texas, United States
• Study site — Wharton, Texas, United States
• Study site — Clinton, Utah, United States
• Study site — Kirkland, Washington, United States
• Study site — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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