NCT00562055

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2007

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

First QC Date

November 19, 2007

Last Update Submit

April 11, 2019

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

  • Adult ADHD Investigator Symptom Rating Scale - Total Score

    4 weeks

Secondary Outcomes (2)

  • Adult ADHD Investigator Symptom Rating Scale - Inattention Subscale Score

    4 weeks

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

    4 weeks

Study Arms (2)

Arm A

EXPERIMENTAL
Drug: PNU-165442G; [S,S]-reboxetine

Arm B

ACTIVE COMPARATOR
Drug: Atomoxetine

Interventions

AtomoxetineDRUG
Arm B
PNU-165442G; [S,S]-reboxetineDRUG
Arm A

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Significant comorbid psychiatric diagnoses
  • Significant risk of suicidal or violent behavior

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 19, 2007

First Posted

November 21, 2007

Study Start

November 1, 2007

Last Updated

April 16, 2019

Record last verified: 2019-04