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

This study has been completed.
Sponsor:
Information provided by:
Addrenex Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00641329
First received: March 19, 2008
Last updated: April 8, 2010
Last verified: March 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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
Experimental: 1 Drug: CLONICEL (clonidine HCl sustained release)
Flexible Dose (0.1 - 0.4 mg)
Placebo Comparator: 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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, 73116
Oklahoma City, Oklahoma, United States, 73103
United States, Texas
Houston, Texas, United States, 77074
Houston, Texas, United States, 77007
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.
Investigators
Study Director: Moise Khayrallah, PhD Addrenex Pharmaceuticals
  More Information

No publications provided

Responsible Party: Moise Khayrallah, PhD / President & CEO, Addrenex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00641329     History of Changes
Other Study ID Numbers: CLON-302
Study First Received: March 19, 2008
Last Updated: April 8, 2010
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:
Clonidine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antihypertensive Agents
Cardiovascular Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014