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

NCT ID: NCT00641329

Last Updated: 2010-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-02-28

Brief Summary

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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).

Detailed Description

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Conditions

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ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

CLONICEL (clonidine HCl sustained release)

Intervention Type DRUG

Flexible Dose (0.1 - 0.4 mg)

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo tablets

Interventions

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CLONICEL (clonidine HCl sustained release)

Flexible Dose (0.1 - 0.4 mg)

Intervention Type DRUG

Placebo

Matching placebo tablets

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Addrenex Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Addrenex Pharmaceuticals

Principal Investigators

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Moise Khayrallah, PhD

Role: STUDY_DIRECTOR

Addrenex Pharmaceuticals

Locations

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Little Rock, Arkansas, United States

Site Status

El Centro, California, United States

Site Status

Irvine, California, United States

Site Status

San Diego, California, United States

Site Status

Bradenton, Florida, United States

Site Status

Lauderhill, Florida, United States

Site Status

Miami, Florida, United States

Site Status

Bardstown, Kentucky, United States

Site Status

Baltimore, Maryland, United States

Site Status

St Louis, Missouri, United States

Site Status

Clementon, New Jersey, United States

Site Status

Chapel Hill, North Carolina, United States

Site Status

Durham, North Carolina, United States

Site Status

Cleveland, Ohio, United States

Site Status

Oklahoma City, Oklahoma, United States

Site Status

Oklahoma City, Oklahoma, United States

Site Status

Houston, Texas, United States

Site Status

Houston, Texas, United States

Site Status

Lake Jackson, Texas, United States

Site Status

Wharton, Texas, United States

Site Status

Clinton, Utah, United States

Site Status

Kirkland, Washington, United States

Site Status

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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CLON-302

Identifier Type: -

Identifier Source: org_study_id

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