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

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

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-10-31

Brief Summary

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The objective of this study is to evaluate the long-term effects and tolerability of ABT-089 in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).

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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

Subjects will take up to 80 mg daily for 24 months

Interventions

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ABT-089

Subjects will take up to 80 mg daily for 24 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The subject was randomized into Study M10-346 and completed the study.
* Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements.
* Male subjects must agree to comply with applicable contraceptive requirements.
* The subject is judged to be in generally good health.

Exclusion Criteria

* The subject has taken any ADHD medication between the last dose of study drug in Study M10-346 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