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| Sponsor: | Addrenex Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Addrenex Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00556959 |
Purpose
The purpose of this study is to determine whether CLONICEL® (clonidine HCl sustained release) is a safe and effective treatment for children and adolescents with attention deficit hyperactivity disorder (ADHD).
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Disorder With Hyperactivity |
Drug: high dose clonidine HCl sustained release Drug: low dose 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: | A Phase III, Dose-Response Evaluation of the Efficacy and Safety of CLONICEL® (Clonidine HCl Sustained Release) vs. Placebo in the Treatment of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) |
| Enrollment: | 236 |
| Study Start Date: | October 2007 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
CLONICEL High Dose
|
Drug: high dose clonidine HCl sustained release
high dose clonidine HCl sustained release tablets for 8 weeks
|
|
2: Experimental
CLONICEL Low Dose
|
Drug: low dose clonidine HCl sustained release
low dose clonidine HCl sustained release tablets for 8 weeks
|
|
3: Placebo Comparator
Placebo
|
Drug: placebo
placebo tablets for 8 weeks
|
Clonidine is a centrally acting alpha2 adrenergic agonist that has been used effectively since the early 70s to treat mild to moderate hypertension. In addition to hypertension, clonidine has been evaluated and used extensively for several other indications, including attention deficit hyperactivity disorder (ADHD).
An easy to administer clonidine formulation is needed that retains the efficacy of the current oral formulation but has an improved safety profile. The current trial will investigate the safety and efficacy of clonidine delivered from the sustained release formulation of CLONICEL in the treatment of children and adolescents with ADHD.
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| Gainesville, Florida, United States, 32607 | |
| Orlando, Florida, United States, 32806 | |
| Jacksonville, Florida, United States, 32216 | |
| Miami, Florida, United States, 33161 | |
| United States, Michigan | |
| Rochester Hills, Michigan, United States, 48307 | |
| United States, New Jersey | |
| Voorhees, New Jersey, United States, 08043 | |
| Clementon, New Jersey, United States, 08021 | |
| United States, North Carolina | |
| Chapel Hill, North Carolina, United States, 27514 | |
| Charlotte, North Carolina, United States, 28209 | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States, 73116 | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| United States, Texas | |
| Lake Jackson, Texas, United States, 77566 | |
| Houston, Texas, United States, 77007 | |
| Study Director: | Moise A Khayrallah, PhD | Addrenex Pharmaceuticals, Inc. |
More Information
| Responsible Party: | Addrenex Pharmaceuticals ( Moise Khayrallah, PhD / President & CEO ) |
| Study ID Numbers: | CLON-301 |
| Study First Received: | November 8, 2007 |
| Last Updated: | August 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00556959 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
ADHD Clonidine Attention Deficit |
Hyperactivity CLONICEL Addrenex |
|
Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic Agonists Signs and Symptoms Pathologic Processes Attention Deficit Disorder with Hyperactivity Mental Disorders Sensory System Agents Therapeutic Uses Mental Disorders Diagnosed in Childhood Hyperkinesis Analgesics |
Sympatholytics Adrenergic alpha-Agonists Disease Clonidine Nervous System Diseases Attention Deficit and Disruptive Behavior Disorders Cardiovascular Agents Antihypertensive Agents Dyskinesias Pharmacologic Actions Autonomic Agents Neurologic Manifestations Peripheral Nervous System Agents Central Nervous System Agents |