A Study to Evaluate the Efficacy and Safety of Two Doses of PF-03654746 in Adults With Attention Deficit Hyperactivity Disorder (ADHD).

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00531752
First received: September 18, 2007
Last updated: September 9, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: PF-03654746
Drug: Placebo capsules
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To assess the efficacy of fixed and flexible doses of PF-03654746 compared to placebo in adults with ADHD as measured by the average change across 3 weeks in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To characterize the safety of fixed and flexible doses of PF-3654746 compared to placebo [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • To assess the efficacy of PF-03654746 compared to placebo as measured by proportion of participants who achieve a minimum of 30% decrease in total score on AISRS at the end of week 3 of active treatment [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • To assess the efficacy of PF-03654746 compared to placebo as measured by proportion of participants achieving remission defined as a 1 or 2 on the ADHD Clinical Global Impression - Severity Scale (CGIS) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • To assess the efficacy of PF-03654746 compared to placebo as measured by proportion of participants achieving remission as defined as total score of less than or equal to 18 on the ASIRS scale. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • To assess the effects of PF-03654746 compared to placebo on sleep as measured by the Subjective Sleep Questionnaire (SSQ). [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • To assess the exposure of PF-03654746 in adult subjects with ADHD. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • To assess the efficacy of PF-03654746 as compared with placebo on the ADHD Impact Module - Adults (AIM-A). [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • To assess the efficacy of PF-03654746 as compared with placebo on the Adult ADHD Quality of Life Scale (AAQOL). [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • To assess the effects of PF-03654746 compared to placebo on sleep as measured by the Medical Outcome Study-Sleep Scale (MOS-SS). [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • To assess the effect of PF-03654746 compared to placebo on co-morbid depressive symptoms as measured by the Montgomery Asberg Depression Rating Scale (MADRS). [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • To assess the effect of PF-03654746 compared to placebo on co-morbid anxiety symptoms as measured by the Hamilton Anxiety Scale (HAM-A). [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • To assess the efficacy of PF-03654746 as compared with placebo on the functional impairment as measured by Sheehan Disability Scale (SDS). [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • To assess the efficacy of PF-03654746 compared to placebo as measured by the time to sustained onset, based on daily self ratings of symptom severity using the Time-Sensitive ADHD Symptom Scale (TASS). [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: December 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo capsules
Dosage Form: matching placebo capsules Dosage: Subjects will take two placebo capsules each morning throughout the 3 week double-blind treatment placebo treatment period.
Experimental: Flexible Dose Drug: PF-03654746
Dosage Form: 0.5 mg capsules of PF-03654746 Dosage: 0.5 mg QD for Days 1-7, then 1.0 mg QD Days 8-14, then 2.0 mg QD Days 15-21
Experimental: Fixed Dose Drug: PF-03654746
Dosage Form: 0.5 mg capsules of PF-03654746 Dosage: 1 mg (2 x 0.5 mg capsules) of PF-03654746 given daily for three weeks

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531752

Locations
United States, California
Pfizer Investigational Site
Lafayette, California, United States, 94549
Pfizer Investigational Site
Los Alamitos, California, United States, 90720
Pfizer Investigational Site
Newport Beach, California, United States, 92660
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60608
United States, Massachusetts
Pfizer Investigational Site
Cambridge, Massachusetts, United States, 02138
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10010
United States, Virginia
Pfizer Investigational Site
Herndon, Virginia, United States, 20170
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00531752     History of Changes
Other Study ID Numbers: A8801004
Study First Received: September 18, 2007
Last Updated: September 9, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014