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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This study has been withdrawn prior to enrollment.
(This study was withdrawn due to business reasons.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00562055
First received: November 19, 2007
Last updated: June 19, 2008
Last verified: June 2008
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

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

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

No publications provided

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

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Atomoxetine
Reboxetine
 Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013