At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 230 enrolled
Drug / intervention
Methylphenidate Hydrochloride Extended Release Capsules +1 moredrug
Likely dose
Not stated in 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.
A Randomized, Parallel, Double-Blind Efficacy and Safety Study of Biphentin Methylphenidate HCl Extended Release Capsules Compared to Placebo in Children and Adolescents 6 to 18 Years With Attention Deficit Hyperactivity Disorder (ADHD)
In Brief
A Phase 3 clinical trial evaluating Methylphenidate Hydrochloride Extended Release Capsules and Placebo for Attention Deficit Hyperactivity Disorder and ADHD. Completed, enrolled 230 participants across 16 sites.
Detailed Summary
This multi-center parallel study is designed to study the efficacy and safety of fixed doses of methylphenidate extended release (ER) capsules of four dose levels compared with a placebo group in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) who are between 6 and 18 years old.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder, ADHD
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2010
First PostedNov 2010
Primary CompletionFeb 2012
Study CompletionMar 2012
TodayJul 2026
First PostedNov 11, 2010
Enrollment StartNov 1, 2010
Primary CompletionFeb 1, 2012
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.6 years ago
Interventions
Methylphenidate Hydrochloride Extended Release Capsulesdrug
Biphentin Methylphenidate ER Once-A-Day Capsules
Placebodrug
Placebo capsules