CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 212 enrolled
Drug / intervention
Guanfacine +1 moredrug
Likely dose
Guanfacine 0.5 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.

Search/NCT00429273
NCT00429273Phase 4Completed
CompareCT.gov

An Eight-Week, Randomized, Double-Blind Comparison of Guanfacine, Focalin XR, and the Combination, With a Twelve Month Open-Label Extension for the Treatment of ADHD in Pediatric Subjects Aged 7 to 14 Years

University of California, Los Angeles·interventional·Posted Jan 31, 2007·Updated Jul 30, 2021

In Brief

A Phase 4 clinical trial evaluating Guanfacine and Methylphenidate (MPH) for Attention Deficit Disorder With Hyperactivity. Completed, enrolled 212 participants across 1 site.

Detailed Summary

This study will evaluate the effectiveness of a single drug versus a combination of drugs in treating attention deficit hyperactivity disorder in children.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Disorder With Hyperactivity
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 31, 2007
Enrollment StartJan 1, 2007
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 19.4 years ago

Interventions

Guanfacinedrug

Week 1: 0.5 mg twice daily; Week 2: 1 mg twice daily; Week 3: 1.5 mg twice daily; Weeks 4 through 8: best dose as determined by efficacy measures

Methylphenidate (MPH)drug

Participants less than 25 kg will receive 10 mg once daily for Week 5, 20 mg once daily for Week 6, and 30 mg once daily for Week 7. Subjects greater than 25 kg will receive 20 mg once daily for Week 5, 30 mg once daily for Week 6, 40 mg once daily for Week 7, and best doses as determined by efficacy measures for Week 8.