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

This study has been completed.

First Received: March 19, 2008 Last Updated: March 24, 2009 History of Changes

Sponsor:	Addrenex Pharmaceuticals, Inc.
Information provided by:	Addrenex Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00641329

Purpose

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	Intervention	Phase
ADHD	Drug: CLONICEL (clonidine HCl sustained release) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: Clonidine Clonidine hydrochloride

U.S. FDA Resources

Further study details as provided by Addrenex Pharmaceuticals, Inc.:

Primary Outcome Measures:

ADHDRS-IV Total Score [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
Treatment Emergent Adverse Events, Laboratory Tests, Vital Signs, and ECGs [ Time Frame: Throughout Treatment and Follow-up Period ] [ Designated as safety issue: Yes ]

Enrollment:	198
Study Start Date:	February 2008
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: CLONICEL (clonidine HCl sustained release) Flexible Dose (0.1 - 0.4 mg)
2: Placebo Comparator	Drug: Placebo Matching placebo tablets

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641329

Locations

United States, Arkansas

Little Rock, Arkansas, United States, 72205
United States, California

San Diego, California, United States, 92103

Irvine, California, United States, 92612

El Centro, California, United States, 92243
United States, Florida

Miami, Florida, United States, 33161

Bradenton, Florida, United States, 34208

Lauderhill, Florida, United States, 33319
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

Durham, North Carolina, United States, 27705

Chapel Hill, North Carolina, United States, 27514
United States, Ohio

Cleveland, Ohio, United States, 44106
United States, Oklahoma

Oklahoma City, Oklahoma, United States, 73116

Oklahoma City, Oklahoma, United States, 73103
United States, Texas

Houston, Texas, United States, 77007

Lake Jackson, Texas, United States, 77566

Wharton, Texas, United States, 77488

Houston, Texas, United States, 77074
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.

Investigators

Study Director:

Moise Khayrallah, PhD

Addrenex Pharmaceuticals

More Information

Additional Information:

Addrenex Pharmaceuticals This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Addrenex Pharmaceuticals ( Moise Khayrallah, PhD / President & CEO )
Study ID Numbers:	CLON-302
Study First Received:	March 19, 2008
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00641329 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Addrenex Pharmaceuticals, Inc.:

ADHD
ADD
Attention Deficit Hyperactivity Disorder
Attention Deficit

Clonidine
CLONICEL
Addrenex

Additional relevant MeSH terms:

Sympatholytics
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Clonidine
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents

Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010