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

This study has been withdrawn prior to recruitment.
( This study was withdrawn due to business reasons. )

Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00562055
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: Atomoxetine
Drug: PNU-165442G; [S,S]-reboxetine
Phase II

MedlinePlus related topics:   Attention Deficit Hyperactivity Disorder   

ChemIDplus related topics:   Reboxetine    Reboxetine mesylate    Atomoxetine    Atomoxetine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Adult ADHD Investigator Symptom Rating Scale - Total Score [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Adult ADHD Investigator Symptom Rating Scale - Inattention Subscale Score [ Time Frame: 4 weeks ]
  • Adult ADHD Investigator Symptom Rating Scale - Hyperactivity/Impulsivity Subscale Score [ Time Frame: 4 weeks ]

Estimated Enrollment:   96
Study Start Date:   November 2007

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

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562055

Sponsors and Collaborators
Pfizer

Investigators
Study Director:     Pfizer CT.gov Call Center     Pfizer    
  More Information


To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Pfizer, Inc. ( Director, Clinical Trial Disclosure )
Study ID Numbers:   A6061060, A6061060
First Received:   November 19, 2007
Last Updated:   June 19, 2008
ClinicalTrials.gov Identifier:   NCT00562055
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Atomoxetine
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias
Reboxetine

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on October 07, 2008




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