At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 279 enrolled
Drug / intervention
prolonged release (PR) OROS methylphenidate 54 mg +2 moredrug
Likely dose
prolonged release (PR) OROS methylphenidate 54 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.
A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study to Evaluate Efficacy and Safety of Prolonged Release (PR) OROS Methylphenidate (54 and 72 mg/Day) in Adults With Attention Deficit/Hyperactivity Disorder
In Brief
A Phase 3 clinical trial evaluating prolonged release (PR) OROS methylphenidate 54 mg, prolonged release (PR) OROS methylphenidate 72 mg, and 1 other intervention for Attention Deficit/ Hyperactivity Disorder. Completed, enrolled 279 participants across 42 sites in 11 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy of 2 fixed dosages of Prolonged Release (PR) OROS methylphenidate (54 and 72 mg/day) compared with placebo in adult patients with attention deficit/hyperactivity disorder (ADHD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Denmark, Finland, France, Germany, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedJul 2008
Primary CompletionApr 2009
TodayJul 2026
First PostedJul 14, 2008
Enrollment StartFeb 1, 2008
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.0 years ago
Interventions
prolonged release (PR) OROS methylphenidate 54 mgdrug
18+36mg once daily for 13 weeks
prolonged release (PR) OROS methylphenidate 72 mgdrug
2x36mg once daily for 13 weeks
Placebodrug
2xplacebo once daily for 13 weeks