CLONICEL (Clonidine Sustained Release) as Add-on to Stimulant Medication in 6 to 17 Yr-olds With ADHD
This study has been completed.
Sponsor:
Addrenex Pharmaceuticals, Inc.
Information provided by:
Addrenex Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00641329
First received: March 19, 2008
Last updated: April 8, 2010
Last verified: March 2009
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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
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:
|
Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Clonidine Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013