A Safety and Tolerability Study of ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD)

NCT ID: NCT00443391

Last Updated: 2013-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-10-31

Brief Summary

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The objective of this study is to evaluate the long-term safety and tolerability of ABT-089 in adults with ADHD.

Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

ABT-089

Intervention Type DRUG

Open label study, subjects will take up to 80mg daily for 24 months.

Interventions

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ABT-089

Open label study, subjects will take up to 80mg daily for 24 months.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The subject was randomized into Study M06-855 and completed treatment in Periods 1 and 2 and the 2-week Extension Period
* If female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least a method of birth control throughout the study
* If female, the result of a pregnancy tests are negative
* The subject is judged to be in generally good health

Exclusion Criteria

* More than 7 days have elapsed since the last dose of study drug in Study M06-855
* The subject has taken any ADHD medication between the last dose of study drug in Study M06-855 and the first dose of study drug in the current study
* The subject anticipates a move outside the geographic area
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Gault, MD, PhD, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 6109

Mesa, Arizona, United States

Site Status

Site Reference ID/Investigator# 6765

Mesa, Arizona, United States

Site Status

Site Reference ID/Investigator# 6100

Lafayette, California, United States

Site Status

Site Reference ID/Investigator# 6107

San Diego, California, United States

Site Status

Site Reference ID/Investigator# 6112

Jacksonville, Florida, United States

Site Status

Site Reference ID/Investigator# 6096

Maitland, Florida, United States

Site Status

Site Reference ID/Investigator# 6105

Tampa, Florida, United States

Site Status

Site Reference ID/Investigator# 6094

Smyrna, Georgia, United States

Site Status

Site Reference ID/Investigator# 6111

Newton, Kansas, United States

Site Status

Site Reference ID/Investigator# 6113

Farmington Hills, Michigan, United States

Site Status

Site Reference ID/Investigator# 6110

Omaha, Nebraska, United States

Site Status

Site Reference ID/Investigator# 6099

New York, New York, United States

Site Status

Site Reference ID/Investigator# 6106

Chapel Hill, North Carolina, United States

Site Status

Site Reference ID/Investigator# 6102

Portland, Oregon, United States

Site Status

Site Reference ID/Investigator# 6097

Charleston, South Carolina, United States

Site Status

Site Reference ID/Investigator# 6098

Memphis, Tennessee, United States

Site Status

Site Reference ID/Investigator# 6103

Austin, Texas, United States

Site Status

Site Reference ID/Investigator# 6104

Lake Jackson, Texas, United States

Site Status

Site Reference ID/Investigator# 6095

Herndon, Virginia, United States

Site Status

Site Reference ID/Investigator# 6092

Seattle, Washington, United States

Site Status

Site Reference ID/Investigator# 6101

Middleton, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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M06-889

Identifier Type: -

Identifier Source: org_study_id

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