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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


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 Score

Treatment Emergent Adverse Events, Laboratory Tests, Vital Signs, and ECGs


Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.


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

Page last updated: August 20, 2015

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