CLONICEL (Clonidine Sustained Release) as Add-on to Stimulant Medication in 6 to 17 Yr-olds With ADHD
Information source: Addrenex Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: ADHD
Intervention: CLONICEL (clonidine HCl sustained release) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Addrenex Pharmaceuticals, Inc. Official(s) and/or principal investigator(s): Moise Khayrallah, PhD, Study Director, Affiliation: Addrenex Pharmaceuticals
Summary
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).
Clinical Details
Official title: Phase III Evaluation of the Safety and Efficacy of CLONICEL (Clonidine HCl Sustained Release) as Add-on to Psychostimulant Medication vs. Psychostimulant Medication Alone in Children and Adolescents With ADHD
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: ADHDRS-IV Total ScoreTreatment Emergent Adverse Events, Laboratory Tests, Vital Signs, and ECGs
Eligibility
Minimum age: 6 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Clinically significant illnesses or abnormalities upon evaluation
- Conduct Disorder
- Intolerance to clonidine
- History of seizures or syncope
Locations and Contacts
Little Rock, Arkansas 72205, United States
El Centro, California 92243, United States
Irvine, California 92612, United States
San Diego, California 92103, United States
Bradenton, Florida 34208, United States
Lauderhill, Florida 33319, United States
Miami, Florida 33161, United States
Bardstown, Kentucky 40004, United States
Baltimore, Maryland 21208, United States
St. Louis, Missouri 63005, United States
Clementon, New Jersey 08021, United States
Chapel Hill, North Carolina 27514, United States
Durham, North Carolina 27705, United States
Cleveland, Ohio 44106, United States
Oklahoma City, Oklahoma 73103, United States
Oklahoma City, Oklahoma 73116, United States
Houston, Texas 77007, United States
Houston, Texas 77074, United States
Lake Jackson, Texas 77566, United States
Wharton, Texas 77488, United States
Clinton, Utah 84015, United States
Kirkland, Washington 98033, United States
Spokane, Washington 99202, United States
Additional Information
Starting date: February 2008
Last updated: April 8, 2010
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