A Study to Evaluate the Efficacy and Safety of Two Doses of PF-03654746 in Adults With Attention Deficit Hyperactivity Disorder (ADHD).
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | December 2007 |
| End Date: | September 2008 |
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.
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.
We found this trial at
7
sites
New York University School of Medicine NYU School of Medicine has a proud history that...
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