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

ADHD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00641329
• Other study ID #: CLON-302
• Status: Completed
• Phase: Phase 3
• First received: March 19, 2008
• Last updated: April 8, 2010
• Start date: February 2008
• Est. completion date: February 2009

Study information

• Verified date: March 2009
• Source: Addrenex Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Addrenex Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHDRS-IV Total Score		Week 5	No
Primary	Treatment Emergent Adverse Events, Laboratory Tests, Vital Signs, and ECGs		Throughout Treatment and Follow-up Period	Yes