Who is sponsoring NCT00485550?

NCT00485550 is sponsored by Eli Lilly and Company.

What drugs are being tested in NCT00485550?

Interventions in NCT00485550: Atomoxetine Hydrochloride, Methylphenidate Hydrochloride, Placebo.

What condition does NCT00485550 study?

NCT00485550 studies Attention Deficit Hyperactivity Disorder.

Is NCT00485550 still recruiting?

NCT00485550 is currently completed. Last updated 11 June 2007.

Last reviewed 2007-06-11 · How we verify

NCT00485550

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

A Randomized, Double-Blind Comparison of Atomoxetine Hydrochloride Augmented With Either Extended-Release Methylphenidate Hydrochloride (Concerta-TM) or Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) Who Have Not Responded to Stimulant Mono Therapy

Completed Phase 3 Last updated 11 June 2007

What this trial tests

Phase 3 trial testing Atomoxetine Hydrochloride in Attention Deficit Hyperactivity Disorder in 14 participants. Completed in 1 March 2005.

Timeline

1 January 2004

1 March 2005

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	14
Start date	1 January 2004
Estimated completion	1 March 2005
Sites	1 location across United States

Drugs / interventions tested

Atomoxetine Hydrochloride — full drug profile →
Methylphenidate Hydrochloride — full drug profile →
Placebo

Conditions studied

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

Sponsor

Eli Lilly and Company — 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.

Assess the safety of atomoxetine and placebo compared to atomoxetine and methylphenidate in children aged 6 through 12 years with ADHD who have been identified as stimulant non-responders and have been exposed to acute treatment of atomoxetine.

Sponsor's own description

The purpose of this study is to evaluate the safety and tolerability of atomoxetine alone versus atomoxetine plus low-dose, sustained-release MPH in children with treatment-resistant ADHD.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD).
Storebø OJ, Storm MRO, Pereira Ribeiro J, Skoog M, et al · · 2023 · cited 32× · PMID 36971690 · DOI 10.1002/14651858.cd009885.pub3

Verify or expand the search:

Other trials of Atomoxetine Hydrochloride

Trials testing the same drug.

NCT05071612 — Parallel Arm Trial of AD109 and AD504 In Patients With OSA · Phase 2 · completed
NCT03154359 — Atomoxetine PBPK-PD Clinical Study · completed
NCT01244490 — Efficacy and Safety of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attent · Phase 3 · completed
NCT01106430 — Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjec · Phase 3 · completed

Other recruiting trials for Attention Deficit Hyperactivity Disorder

Currently open trials in the same condition.

NCT07001475 — A Study to Test How BI 3031185 is Tolerated by People With Borderline Personality Disorder or Attention-deficit/Hyperact · Phase 1 · recruiting
NCT06847165 — Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure · NA · recruiting
NCT06325813 — ADHD PreSMA Response Inhibition Therapy · NA · recruiting
NCT06248229 — A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With Attention Deficit Hyperactivity Disorder · Phase 4 · recruiting
NCT06232226 — Attention Deficit Hyperactivity Disorder · NA · recruiting

Other Eli Lilly and Company trials

Trials by the same sponsor.

NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) · Phase 2 · not yet recruiting
NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo · Phase 2 · not yet recruiting
NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants · Phase 1 · completed
NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants · Phase 1 · completed
NCT07030127 — A Study of LY3985863 in Healthy Participants · Phase 1 · 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 NCT00485550 (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 Eli Lilly and Company
Last refreshed: 11 June 2007

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/NCT00485550.

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