A Study of the Effectiveness and Safety of Prolonged-release Methylphenidate Hydrochloride in Adult Patients With Attention Deficit/Hyperactivity Disorder.
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|ClinicalTrials.gov Identifier: NCT00246220|
Recruitment Status : Completed
First Posted : October 30, 2005
Last Update Posted : May 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Disorder With Hyperactivity||Drug: methylphenidate hydrochloride||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||402 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study To Evaluate the Safety And Efficacy Of Prolonged Release OROS Methylphenidate Hydrochloride (18, 36 and 72 mg/Day), With Open-Label Extension, In Adults With Attention Deficit/Hyperactivity Disorder|
|Study Start Date :||March 2005|
|Actual Study Completion Date :||November 2006|
- Change from baseline in the sum of the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated Conners' Adult ADHD Rating Scale at the end of the double-blind phase (5 weeks) compared with placebo.
- Changes from baseline to the end of treatment in: Conners' Adult ADHD Rating Scale; Clinical Global Impression; Sheehan's Disability Scale; Quality of Life Enjoyment and Satisfaction Questionnaire; and Global Assessment of Effectiveness
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246220
|Study Director:||Janssen Pharmaceutica N.V. Clinical Trial||Janssen Pharmaceutica N.V.|