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A Safety and Efficacy Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT00528697 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2013-01-29

No results posted yet for this study

Summary

The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for children with Attention-Deficit/Hyperactivity Disorder or ADHD.

Conditions

  • Attention-Deficit/Hyperactivity Disorder

Interventions

DRUG

ABT-089

Subjects will take 0.5 and 1 and/or 5 and/or 10 mg ABT-089 tablets (actual dose based on weight) once daily for 8 weeks.

DRUG

atomoxetine

Subjects will take 10, and/or 18 and/or 25 mg atomoxetine tablets once daily for 8 weeks.

DRUG

placebo

Subject will take a tablet once daily for 8 weeks

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Laura Gault, MD, PhD, MD · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00528697 on ClinicalTrials.gov