Double-Blind, Four Week Trial Of [S,S]-Reboxetine And Ato... | NCT00562055

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

NCT00562055

Sponsor

Pfizer

Status

Withdrawn

Last Update Posted

Apr 16, 2019Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

Atomoxetine
PNU-165442G; [S,S]-reboxetine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
A6061060

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study was withdrawn due to business reasons.

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 19, 2007

First Submission Date that Met QC Criteria

Nov 19, 2007

First Posted Date

Nov 21, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2019

Last Update Posted Date

Apr 16, 2019Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
Arm A	Experimental		Drug: PNU-165442G; [S,S]-reboxetine
Arm B	Active Comparator		Drug: Atomoxetine

Name	Type	Description	Arm Group Labels	Other Names
Atomoxetine	Drug		Arm B
PNU-165442G; [S,S]-reboxetine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adult ADHD Investigator Symptom Rating Scale - Total Score		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Adult ADHD Investigator Symptom Rating Scale - Inattention Subscale Score		4 weeks
Adult ADHD Investigator Symptom Rating Scale - Hyperactivity/Impulsivity Subscale Score		4 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Label	URL
To obtain contact information for a study center near you, click here.	View source

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069445	Atomoxetine Hydrochloride

Ancestor Terms

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided