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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00641329
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : April 9, 2010
Information provided by:
Addrenex Pharmaceuticals, Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
ADHD Drug: CLONICEL (clonidine HCl sustained release) Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2008
Primary Completion Date : February 2009
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: CLONICEL (clonidine HCl sustained release)
Flexible Dose (0.1 - 0.4 mg)
Placebo Comparator: 2 Drug: Placebo
Matching placebo tablets

Primary Outcome Measures :
  1. ADHDRS-IV Total Score [ Time Frame: Week 5 ]
  2. Treatment Emergent Adverse Events, Laboratory Tests, Vital Signs, and ECGs [ Time Frame: Throughout Treatment and Follow-up Period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00641329

United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
El Centro, California, United States, 92243
Irvine, California, United States, 92612
San Diego, California, United States, 92103
United States, Florida
Bradenton, Florida, United States, 34208
Lauderhill, Florida, United States, 33319
Miami, Florida, United States, 33161
United States, Kentucky
Bardstown, Kentucky, United States, 40004
United States, Maryland
Baltimore, Maryland, United States, 21208
United States, Missouri
St. Louis, Missouri, United States, 63005
United States, New Jersey
Clementon, New Jersey, United States, 08021
United States, North Carolina
Chapel Hill, North Carolina, United States, 27514
Durham, North Carolina, United States, 27705
United States, Ohio
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73103
Oklahoma City, Oklahoma, United States, 73116
United States, Texas
Houston, Texas, United States, 77007
Houston, Texas, United States, 77074
Lake Jackson, Texas, United States, 77566
Wharton, Texas, United States, 77488
United States, Utah
Clinton, Utah, United States, 84015
United States, Washington
Kirkland, Washington, United States, 98033
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Addrenex Pharmaceuticals, Inc.
Study Director: Moise Khayrallah, PhD Addrenex Pharmaceuticals

Responsible Party: Moise Khayrallah, PhD / President & CEO, Addrenex Pharmaceuticals Identifier: NCT00641329     History of Changes
Other Study ID Numbers: CLON-302
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: April 9, 2010
Last Verified: March 2009

Keywords provided by Addrenex Pharmaceuticals, Inc.:
Attention Deficit Hyperactivity Disorder
Attention Deficit

Additional relevant MeSH terms:
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action