CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 340 enrolled
Drug / intervention
LY2216684 +3 moredrug
Likely dose
Methylphenidate 18 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/NCT00922636
NCT00922636Phase 3Completed

A Fixed-Dose, Randomized, Double-Blind, Placebo-Controlled Study of LY2216684 in Pediatric Patients With Attention Deficit/Hyperactivity Disorder

Eli Lilly and Company·interventional·Posted Jun 17, 2009·Updated Aug 18, 2014

In Brief

A Phase 3 clinical trial evaluating LY2216684, Methylphenidate, and 2 other interventions for Attention Deficit Hyperactivity Disorder. Completed, enrolled 340 participants across 19 sites in 3 countries.

Detailed Summary

The primary purpose of your child's participation in this study is to determine whether LY2216684 can help pediatric patients with attention-deficit/hyperactivity disorder (ADHD); and assess the safety of LY2216684 and any side effects that might be associated with it.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Puerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 17, 2009
Enrollment StartJun 1, 2009
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.0 years ago

Interventions

LY2216684drug

Taken in tablet form QD po.

Methylphenidatedrug

Extended-release methylphenidate 18 mg/day to 54 mg/day, based on weight, QD po as a capsule for the 8-week double-blind treatment phase.

Placebo (tablet)drug

Placebo given as a tablet for LY2216684 blind QD po for the 8-week double-blind treatment phase, followed by 2 weeks in the taper phase.

Placebo (capsule)drug

Placebo given as a capsule for methylphenidate blind QD po for the 8-week double-blind treatment phase followed by 2 weeks in the taper phase.