Back to resultsCLONICEL (Clonidine Sustained Release) as Add-on to Stimulant Medication in 6 to 17 Yr-olds With ADHD
Primary Purpose
ADHD
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CLONICEL (clonidine HCl sustained release)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for ADHD focused on measuring ADHD, ADD, Attention Deficit Hyperactivity Disorder, Attention Deficit, Clonidine, CLONICEL, Addrenex
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
ADHDRS-IV Total Score
Treatment Emergent Adverse Events, Laboratory Tests, Vital Signs, and ECGs
Secondary Outcome Measures
Full Information
NCT ID
NCT00641329
First Posted
March 19, 2008
Last Updated
April 8, 2010
Sponsor
Addrenex Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00641329
Brief Title
CLONICEL (Clonidine Sustained Release) as Add-on to Stimulant Medication in 6 to 17 Yr-olds With ADHD
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Addrenex Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD, ADD, Attention Deficit Hyperactivity Disorder, Attention Deficit, Clonidine, CLONICEL, Addrenex
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CLONICEL (clonidine HCl sustained release)
Intervention Description
Flexible Dose (0.1 - 0.4 mg)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablets
Primary Outcome Measure Information:
Title
ADHDRS-IV Total Score
Time Frame
Week 5
Title
Treatment Emergent Adverse Events, Laboratory Tests, Vital Signs, and ECGs
Time Frame
Throughout Treatment and Follow-up Period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moise Khayrallah, PhD
Organizational Affiliation
Addrenex Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77007
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
City
Wharton
State/Province
Texas
ZIP/Postal Code
77488
Country
United States
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
12. IPD Sharing Statement
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CLONICEL (Clonidine Sustained Release) as Add-on to Stimulant Medication in 6 to 17 Yr-olds With ADHD
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