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Double-Blind, Four Week Trial Of [S,S]-Reboxetine And Atomoxetine In Adults With Attention Deficit Hyperactivity Disorder.

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Atomoxetine
PNU-165442G; [S,S]-reboxetine
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of Attention Deficit Hyperactivity Disorder according to DSM-IV criteria.
  2. Score of 24 or higher on the Adult ADHD Investigator Symptom Rating Scale
  3. Score of 4 or higher on the Clinician Global Impression - Severity scale

Exclusion Criteria:

  1. Significant comorbid psychiatric diagnoses
  2. Significant risk of suicidal or violent behavior

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Arm A

    Arm B

    Arm Description

    Outcomes

    Primary Outcome Measures

    Adult ADHD Investigator Symptom Rating Scale - Total Score

    Secondary Outcome Measures

    Adult ADHD Investigator Symptom Rating Scale - Inattention Subscale Score
    Adult ADHD Investigator Symptom Rating Scale - Hyperactivity/Impulsivity Subscale Score

    Full Information

    First Posted
    November 19, 2007
    Last Updated
    April 11, 2019
    Sponsor
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00562055
    Brief Title
    Double-Blind, Four Week Trial Of [S,S]-Reboxetine And Atomoxetine In Adults With Attention Deficit Hyperactivity Disorder.
    Official Title
    Phase 2, Randomized, Double-Blind, Parallel-Group, Four Week, Efficacy And Safety Trial Of [S,S]-Reboxetine (PNU-165442g) And Atomoxetine In Adults With Attention Deficit Hyperactivity Disorder.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    This study was withdrawn due to business reasons.
    Study Start Date
    November 2007 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Pfizer

    4. Oversight

    5. Study Description

    Brief Summary
    This study will compare the safety and efficacy of [S,S]-reboxetine to atomoxetine in the treatment of adult patients with attention deficity-hyperactivity disorder.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Attention Deficit Hyperactivity Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm A
    Arm Type
    Experimental
    Arm Title
    Arm B
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Atomoxetine
    Intervention Type
    Drug
    Intervention Name(s)
    PNU-165442G; [S,S]-reboxetine
    Primary Outcome Measure Information:
    Title
    Adult ADHD Investigator Symptom Rating Scale - Total Score
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Adult ADHD Investigator Symptom Rating Scale - Inattention Subscale Score
    Time Frame
    4 weeks
    Title
    Adult ADHD Investigator Symptom Rating Scale - Hyperactivity/Impulsivity Subscale Score
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of Attention Deficit Hyperactivity Disorder according to DSM-IV criteria. Score of 24 or higher on the Adult ADHD Investigator Symptom Rating Scale Score of 4 or higher on the Clinician Global Impression - Severity scale Exclusion Criteria: Significant comorbid psychiatric diagnoses Significant risk of suicidal or violent behavior
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6061060&StudyName=DOUBLE-BLIND%2C%20FOUR%20WEEK%20TRIAL%20OF%20%5BS%2CS%5D-REBOXETINE%20AND%20ATOMOXETINE%20IN%20ADULTS%20WITH%20ATTENTION%20DEFICIT%20HYPERACTIVITY%20DISORDER
    Description
    To obtain contact information for a study center near you, click here.

    Learn more about this trial

    Double-Blind, Four Week Trial Of [S,S]-Reboxetine And Atomoxetine In Adults With Attention Deficit Hyperactivity Disorder.

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