A Phase Iia, Randomized, Double Blind, Placebo Controlled, Three-treatment, Two-period Crossover Study Of The Efficacy And Safety Of Two Doses Of Pf-03654746 In Adults With Attention Deficit Hyperactivity Disorder
A Phase Iia, Randomized, Double Blind, Placebo Controlled, Three-treatment, Two-period Crossover Study Of The Efficacy And Safety Of Two Doses Of Pf-03654746 In Adults With Attention Deficit Hyperactivity Disorder
The purpose of this study is to determine whether PF-03654746 is effective in the treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD). This will be a randomized, double-blind, crossover study in which adults with ADHD will receive 3 weeks of treatment with PF-03654746, either a low dose (1 mg), or flexible dose (0.50 mg titrated up to 2 mg), and 3 weeks of placebo. A washout period will separate the 2 treatment periods. Participants will be required to washout of prior ADHD medication before entering the study. Participants will be required to come to the site for 10 visits over approximately a 10-week period.
Inclusion Criteria:
Subjects with a diagnosis of Attention Deficit Hyperactivity Disorder, based on clinical assessment and interview.
Male and female outpatients. Subjects with a diagnosis of Attention Deficit Hyperactivity Disorder, based on clinical assessment and interview.
Female subjects must be of non-childbearing potential.
Exclusion Criteria:
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including hypertension), hepatic, neurologic, or allergic disease.
Current or lifetime history of psychosis or bipolar disorder; any current anxiety disorder (with the exception of social or specific phobia), or substance abuse or dependence in the past 6 months.
Current episode of Major Depression or episode within the last 6 months.
Chicago, Illinois 60608, United States