drugset

drugset / Trial / NCT00326300

A Long-Term Safety Study to Evaluate Methylphenidate HCL Tablets at Multiple Dose Levels in Adults With Attention Deficit Hyperactivity Disorder

NCT00326300 ↗

Phase 3 Completed 560 enrolled McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the long-term safety of methylphenidate HCL extended-release tablets at five dose levels in adults with Attention Deficit Hyperactivity Disorder (ADHD)

Timeline

Start: 2006-04
Primary completion: —
Completion: 2007-08

Publications

Adler LA, Orman C, Starr HL, Silber S, Palumbo J, Cooper K, Berwaerts J, Harrison DD. Long-term safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: an open-label, dose-titration, 1-year study. J Clin Psychopharmacol. 2011 Feb;31(1):108-14. doi: 10.1097/JCP.0b013e318203ea0a.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methylphenidate	Small molecule	36 mg	—
Subject	Methylphenidate	Small molecule	54 mg	—
Subject	Methylphenidate	Small molecule	72 mg	—
Subject	Methylphenidate	Small molecule	90 mg	—
Subject	Methylphenidate	Small molecule	108 mg	—

Indications