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
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
New York University School of Medicine NYU School of Medicine has a proud history that...
Click here to add this to my saved trials
Click here to add this to my saved trials