Who is sponsoring NCT00528697?

NCT00528697 is sponsored by AbbVie (prior sponsor, Abbott).

What drugs are being tested in NCT00528697?

Interventions in NCT00528697: ABT-089, atomoxetine, placebo.

What condition does NCT00528697 study?

NCT00528697 studies Attention-Deficit/Hyperactivity Disorder.

Is NCT00528697 still recruiting?

NCT00528697 is currently completed. Last updated 21 January 2013.

Last reviewed 2013-01-21 · How we verify

NCT00528697

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Dose-Ranging Study of the Safety and Efficacy of ABT-089 in Children With Attention Deficit-Hyperactivity Disorder (ADHD)

Completed Phase 2 Last updated 21 January 2013

What this trial tests

Phase 2 trial testing ABT-089 in Attention-Deficit/Hyperactivity Disorder in 278 participants. Completed in 1 April 2008.

Timeline

1 September 2007

Primary endpoint
1 April 2008

1 April 2008

Quick facts

Lead sponsor	AbbVie (prior sponsor, Abbott)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	278
Start date	1 September 2007
Primary completion	1 April 2008
Estimated completion	1 April 2008
Sites	20 locations across United States

Drugs / interventions tested

ABT-089 — full drug profile →
atomoxetine (ATOMOXETINE) — full drug profile →
placebo

Conditions studied

Attention-Deficit/Hyperactivity Disorder — all drugs for Attention-Deficit/Hyperactivity Disorder →

Sponsor

AbbVie (prior sponsor, Abbott) — full company profile →

Who can join

Adults 6 to 12, any sex, with Attention-Deficit/Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

ADHD-RS-IV (HV) - Administered by study doctor
Time frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42, Day 56

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Safety and efficacy of ABT-089 in pediatric attention-deficit/hyperactivity disorder: results from two randomized placebo-controlled clinical trials.
Wilens TE, Gault LM, Childress A, Kratochvil CJ, et al · · 2011 · cited 30× · PMID 21156272 · DOI 10.1016/j.jaac.2010.10.001
A simple formula for enumerating comparisons in trials and network meta-analysis.
Shokraneh F, Adams CE. · · 2019 · cited 2× · PMID 30863537 · DOI 10.12688/f1000research.17352.2
New frontiers in pharmacological treatment of attention-deficit hyperactivity disorder.
Noah AA, Sedky HE. · · 2025 · PMID 40478337 · DOI 10.1007/s00210-025-04328-z

Verify or expand the search:

Other recruiting trials for Attention-Deficit/Hyperactivity Disorder

Currently open trials in the same condition.

NCT07327775 — Fibromyalgia Disease Burden in Mothers of Children With Attention-Deficit/Hyperactivity Disorder · recruiting

Other AbbVie (prior sponsor, Abbott) trials

Trials by the same sponsor.

NCT01609933 — A Study to Evaluate the Safety and Effect of Treatment With Experimental Antiviral Drugs in Combination With Peginterfer · Phase 2 · completed
NCT01657799 — Comparison of Veliparib and Whole Brain Radiation Therapy (WBRT) Versus Placebo and WBRT in Adults With Brain Metastases · Phase 2 · completed
NCT01736189 — Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice · completed
NCT01620528 — A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Assoc · Phase 3 · completed
NCT01506947 — A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calc · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00528697 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie (prior sponsor, Abbott)
Last refreshed: 21 January 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00528697.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing