At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 303 enrolled
Drug / intervention
CLONICEL (Clonidine HCl sustained release)drug
Likely dose
CLONICEL (Clonidine HCl sustained release) 0.1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Chronic Exposure Evaluation of the Safety of CLONICEL (Clonidine HCl Sustained Release) in the Treatment of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
In Brief
A Phase 3 clinical trial evaluating CLONICEL (Clonidine HCl sustained release) for Attention Deficit Hyperactivity Disorder. Completed, enrolled 303 participants across 27 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2008
First PostedJul 2008
Primary CompletionMar 2010
Study CompletionJun 2010
TodayJul 2026
First PostedJul 28, 2008
Enrollment StartJan 1, 2008
Primary CompletionMar 1, 2010
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.9 years ago
Interventions
CLONICEL (Clonidine HCl sustained release)drug
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