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Open-Label, Chronic Exposure, Safety Study of CLONICEL (Clonidine HCl Sustained Release) in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

NCT00723190 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 303

Last updated 2018-04-18

Study results available
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Summary

The purpose of this 12-month, multi-center, open-label study is to evaluate the safety of CLONICEL (clonidine HCl sustained release) when administered chronically under regular clinical conditions either as monotherapy or in combination with stimulant therapy to children and adolescents with attention deficit hyperactivity disorder (ADHD).

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

CLONICEL (Clonidine HCl sustained release)

0.1 mg for 1 week; the dose may be escalated to 0.2 mg/day at week 2, 0.3 mg/day at week 3, and 0.4 mg/day at week 4

Sponsors & Collaborators

  • Shionogi

    lead INDUSTRY

Principal Investigators

  • Shionogi Clinical Trials Administrator Clinical Support Help Line · Shionogi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-03-31
Completion
2010-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00723190 on ClinicalTrials.gov