NCT00528697

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

7 months

First QC Date

September 11, 2007

Last Update Submit

January 21, 2013

Conditions

Attention-Deficit/Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

  • ADHD-RS-IV (HV) - Administered by study doctor

    Screening, Day -1, Day 7, Day 14, Day 28, Day 42, Day 56

Secondary Outcomes (4)

  • Health Outcomes Measurements

    Baseline to Final Evaluation of 8-week treatment period

  • Clinical Global Impression-ADHD-Severity Scale

    Baseline to Final Evaluation of 8-week treatment period

  • Parent Rating Scales

    Baseline to Final Evaluation of 8-week treatment period

  • Teacher Rating Scale

    Baseline to Final Evaluation of 8-week treatment period

Study Arms (6)

1

EXPERIMENTAL

Lowest ABT-089 dose

Drug: ABT-089

2

EXPERIMENTAL

Low-medium ABT-089 dose

Drug: ABT-089

3

EXPERIMENTAL

Medium-high ABT-089 dose

Drug: ABT-089

4

EXPERIMENTAL

Highest ABT-089 dose

Drug: ABT-089

5

ACTIVE COMPARATOR

atomoxetine

Drug: atomoxetine

6

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

ABT-089DRUG

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.

1234
atomoxetineDRUG

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

5
placeboDRUG

Subject will take a tablet once daily for 8 weeks

6

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Have voluntarily signed an informed consent form
  • Meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) based on detailed evaluation and interview with parent(s)
  • First grade or higher in a school setting 3 days/week
  • Subject is generally in good health based on medical history, physical examination, clinical lab tests, and ECG
  • Subject weighs at least 37 pounds (17 kg)
  • Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements
  • Subject and parents have been judged by the study doctor to be reliable to keep required appointments for clinic visits and all tests, including blood draws, and examinations

You may not qualify if:

  • Subject is not functioning at an age-appropriate level intellectually
  • Subject has a current or past diagnosis of bipolar disorder, psychosis, autism, Asperger's syndrome, or pervasive developmental disorder
  • Current diagnosis of obsessive-compulsive disorder, eating disorder, anxiety disorder or depressive disorder requiring treatment of any kind
  • Subject has a history of significant allergic reaction to any drug
  • Subject requires ongoing treatment with any psychiatric medication
  • Subject has a serious medical condition, seizure disorder (except febrile seizures as an infant), or history of substance abuse or dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Site Reference ID/Investigator# 5999

Little Rock, Arkansas, 72205, United States

Location

Site Reference ID/Investigator# 5979

El Centro, California, 92243, United States

Location

Site Reference ID/Investigator# 5986

Boulder, Colorado, 80304, United States

Location

Site Reference ID/Investigator# 5993

Bradenton, Florida, 34208, United States

Location

Site Reference ID/Investigator# 5995

Jacksonville, Florida, 32216, United States

Location

Site Reference ID/Investigator# 5977

Orlando, Florida, 32806, United States

Location

Site Reference ID/Investigator# 5981

Northbrook, Illinois, 60062, United States

Location

Site Reference ID/Investigator# 5982

Overland Park, Kansas, 66212, United States

Location

Site Reference ID/Investigator# 5992

Omaha, Nebraska, 68198, United States

Location

Site Reference ID/Investigator# 5997

Las Vegas, Nevada, 89128, United States

Location

Site Reference ID/Investigator# 5987

Clementon, New Jersey, 08021, United States

Location

Site Reference ID/Investigator# 5996

Eugene, Oregon, 97401, United States

Location

Site Reference ID/Investigator# 5984

Portland, Oregon, 97210, United States

Location

Site Reference ID/Investigator# 5980

Salem, Oregon, 97301, United States

Location

Site Reference ID/Investigator# 5994

Charleston, South Carolina, 29405, United States

Location

Site Reference ID/Investigator# 5976

Memphis, Tennessee, 38119, United States

Location

Site Reference ID/Investigator# 6000

Austin, Texas, 78756, United States

Location

Site Reference ID/Investigator# 5998

Herndon, Virginia, 20170, United States

Location

Site Reference ID/Investigator# 5978

Bellevue, Washington, 98007, United States

Location

Site Reference ID/Investigator# 5983

Middleton, Wisconsin, 53562, United States

Location

Related Publications (1)

  • Wilens TE, Gault LM, Childress A, Kratochvil CJ, Bensman L, Hall CM, Olson E, Robieson WZ, Garimella TS, Abi-Saab WM, Apostol G, Saltarelli MD. Safety and efficacy of ABT-089 in pediatric attention-deficit/hyperactivity disorder: results from two randomized placebo-controlled clinical trials. J Am Acad Child Adolesc Psychiatry. 2011 Jan;50(1):73-84.e1. doi: 10.1016/j.jaac.2010.10.001. Epub 2010 Nov 25.

    PMID: 21156272DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

pozaniclineAtomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Laura Gault, MD, PhD, MD

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2007

First Posted

September 12, 2007

Study Start

September 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

January 29, 2013

Record last verified: 2013-01

Locations

US(20)