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

NCT00554385 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 283

Last updated 2011-08-23

No results posted yet for this study

Summary

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

Conditions

  • Attention-Deficit/Hyperactivity Disorder

Interventions

DRUG

ABT-089

Up to 4 capsules will be taken once daily for 12 months. Dosage forms include 1 mg, 5 mg, 10 mg capsules and 40 mg tablets. Highest dose allowed is 80 mg per day.

Sponsors & Collaborators

Principal Investigators

  • Laura Gault, M.D., Ph.D. · Abbott

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-08-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00554385 on ClinicalTrials.gov