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

April 8, 2010 updated by: Addrenex Pharmaceuticals, Inc.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • El Centro, California, United States, 92243
      • Irvine, California, United States, 92612
      • San Diego, California, United States, 92103
    • Florida
      • Bradenton, Florida, United States, 34208
      • Lauderhill, Florida, United States, 33319
      • Miami, Florida, United States, 33161
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
    • Maryland
      • Baltimore, Maryland, United States, 21208
    • Missouri
      • St. Louis, Missouri, United States, 63005
    • New Jersey
      • Clementon, New Jersey, United States, 08021
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
      • Durham, North Carolina, United States, 27705
    • Ohio
      • Cleveland, Ohio, United States, 44106
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
      • Oklahoma City, Oklahoma, United States, 73116
    • Texas
      • Houston, Texas, United States, 77007
      • Houston, Texas, United States, 77074
      • Lake Jackson, Texas, United States, 77566
      • Wharton, Texas, United States, 77488
    • Utah
      • Clinton, Utah, United States, 84015
    • Washington
      • Kirkland, Washington, United States, 98033
      • Spokane, Washington, United States, 99202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: CLONICEL (clonidine HCl sustained release)
Flexible Dose (0.1 - 0.4 mg)
Placebo Comparator: 2
Drug: Placebo
Matching placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ADHDRS-IV Total Score
Time Frame: Week 5
Week 5
Treatment Emergent Adverse Events, Laboratory Tests, Vital Signs, and ECGs
Time Frame: Throughout Treatment and Follow-up Period
Throughout Treatment and Follow-up Period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Addrenex Pharmaceuticals, Inc.

Investigators

  • Study Director: Moise Khayrallah, PhD, Addrenex Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 24, 2008

Study Record Updates

Last Update Posted (Estimate)

April 9, 2010

Last Update Submitted That Met QC Criteria

April 8, 2010

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLON-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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