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Clinical Trials/NCT00562055
NCT00562055
Withdrawn
Phase 2

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.

Pfizer0 sitesNovember 2007

Overview

Phase
Phase 2
Intervention
PNU-165442G; [S,S]-reboxetine
Conditions
Attention Deficit Hyperactivity Disorder
Sponsor
Pfizer
Primary Endpoint
Adult ADHD Investigator Symptom Rating Scale - Total Score
Status
Withdrawn
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2007
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Pfizer

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

Arms & Interventions

Arm A

Intervention: PNU-165442G; [S,S]-reboxetine

Arm B

Intervention: Atomoxetine

Outcomes

Primary Outcomes

Adult ADHD Investigator Symptom Rating Scale - Total Score

Time Frame: 4 weeks

Secondary Outcomes

  • Adult ADHD Investigator Symptom Rating Scale - Hyperactivity/Impulsivity Subscale Score(4 weeks)
  • Adult ADHD Investigator Symptom Rating Scale - Inattention Subscale Score(4 weeks)

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