Who is sponsoring NCT00557960?

NCT00557960 is sponsored by Shire.

What drugs are being tested in NCT00557960?

Interventions in NCT00557960: Mixed salts of a single-entity amphetamine, Atomoxetine hydrochloride.

What condition does NCT00557960 study?

NCT00557960 studies Attention Deficit Disorder With Hyperactivity.

Is NCT00557960 still recruiting?

NCT00557960 is currently completed. Last updated 25 May 2021.

Last reviewed 2021-05-25 · How we verify

NCT00557960

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

ADDERALL XR (Mixed Salts of a Single-entity Amphetamine) and STRATTERA ( Atomoxetine Hydrochloride) Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With ADHD

Completed Phase 3 Last updated 25 May 2021

What this trial tests

Phase 3 trial testing Mixed salts of a single-entity amphetamine in Attention Deficit Disorder With Hyperactivity in 36 participants. Completed in 25 October 2004.

Timeline

25 February 2004

Primary endpoint
25 October 2004

25 October 2004

Quick facts

Lead sponsor	Shire
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	36
Start date	25 February 2004
Primary completion	25 October 2004
Estimated completion	25 October 2004
Sites	1 location across United States

Drugs / interventions tested

Mixed salts of a single-entity amphetamine — full drug profile →
Atomoxetine hydrochloride — full drug profile →

Conditions studied

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

Sponsor

Shire — full company profile →

Who can join

Adults 19 to 25, any sex, with Attention Deficit Disorder With Hyperactivity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Evaluate the efficacy of treatment with ADDERALL XR and STRATTERA compared to placebo on simulated driving safety and performance of young adults with ADHD as measured by Driving Safety Scores derived by the Driving Simulator.

Publications & conference data

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

Amphetamines for attention deficit hyperactivity disorder (ADHD) in adults.
Castells X, Blanco-Silvente L, Cunill R. · · 2018 · cited 66× · PMID 30091808 · DOI 10.1002/14651858.cd007813.pub3

Verify or expand the search:

Other recruiting trials for Attention Deficit Disorder With Hyperactivity

Currently open trials in the same condition.

NCT06974136 — tES Modalities for the Treatment of ADHD · NA · recruiting
NCT06764810 — Association Between Motor Skills and Sensory Profiles in Children With Typical and Atypical Development Aged 4 to 11 Yea · recruiting
NCT05621174 — The Difference in the Mechanism of Action Between Two Brands of Dexamfetamine in Adults With ADHD · NA · active not recruiting
NCT06369714 — Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of ADHD in Children. · NA · recruiting
NCT00001246 — Brain Imaging of Childhood Onset Psychiatric Disorders, Endocrine Disorders and Healthy Volunteers · active not recruiting

Other Shire trials

Trials by the same sponsor.

NCT05067868 — A Study of Replagal in Children and Adults With Fabry Disease in India · Phase 4 · recruiting
NCT03878953 — A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism · Phase 3 · withdrawn
NCT04840667 — A Study of Replagal in Treatment-naïve Adults With Fabry Disease · Phase 3 · terminated
NCT04429984 — Post Marketing Surveillance (PMS) Study for Velaglucerase Alfa (VPRIV) in India · completed
NCT04440488 — ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study · Phase 4 · withdrawn

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 NCT00557960 (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 Shire
Last refreshed: 25 May 2021

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/NCT00557960.

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