A Study to Evaluate the Efficacy and Safety of Two Doses of PF-03654746 in Adults With Attention Deficit Hyperactivity Disorder (ADHD).
NCT00531752
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Adult Trials: 18+ Years
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.
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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Study to Evaluate the Efficacy and Safety of Two Doses of PF-03654746 in Adults With Attention Deficit Hyperactivity Disorder (ADHD). | |||
| Official Title ICMJE | 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 | |||
| Brief Summary | 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
| Condition ICMJE | Attention Deficit Hyperactivity Disorder | |||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 66 | |||
| Original Enrollment ICMJE | 48 | |||
| Actual Study Completion Date ICMJE | September 2008 | |||
| Actual Primary Completion Date | September 2008 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | 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. | |||
| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 55 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00531752 | |||
| Other Study ID Numbers ICMJE | A8801004 3-WK, CO MTD IN ADULTS W/ADHD ( Other Identifier: Alias Study Number ) | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Pfizer | |||
| Verification Date | January 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||