CLONICEL (Clonidine Sustained Release) as Add-on to Stimulant Medication in 6 to 17 yr-Olds With ADHD - Tabular View

Tracking Information

First Received Date ^ICMJE

March 19, 2008

Last Updated Date

March 24, 2009

Start Date ^ICMJE

February 2008

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00641329 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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).

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

ADHD

Intervention ^ICMJE

Drug: CLONICEL (clonidine HCl sustained release)
Flexible Dose (0.1 - 0.4 mg)
Drug: Placebo
Matching placebo tablets

Study Arms / Comparison Groups

1: Experimental
Intervention: Drug: CLONICEL (clonidine HCl sustained release)
2: Placebo Comparator
Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

198

Completion Date

February 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00641329

Responsible Party

Moise Khayrallah, PhD / President & CEO, Addrenex Pharmaceuticals

Study ID Numbers ^ICMJE

CLON-302

Study Sponsor ^ICMJE

Addrenex Pharmaceuticals, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Moise Khayrallah, PhD

Addrenex Pharmaceuticals

Information Provided By

Addrenex Pharmaceuticals, Inc.

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP