NCT00928148 is a Phase 2 clinical trial of SPD465 in Attention-Deficit/Hyperactivity Disorder, sponsored by Shire.

Who is sponsoring NCT00928148?

NCT00928148 is sponsored by Shire.

What drugs are being tested in NCT00928148?

Interventions in NCT00928148: SPD465, Immediate Release Amphetamine Salt, Placebo.

What condition does NCT00928148 study?

NCT00928148 studies Attention-Deficit/Hyperactivity Disorder.

Is NCT00928148 still recruiting?

NCT00928148 is currently completed. Last updated 3 June 2021.

Last reviewed 2021-06-03 · How we verify

NCT00928148

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

The Safety and Efficacy of SPD465 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Completed Phase 2 Last updated 3 June 2021

What this trial tests

Phase 2 trial testing SPD465 in Attention-Deficit/Hyperactivity Disorder in 86 participants. Completed in 20 November 2004.

Timeline

14 June 2004

Primary endpoint
20 November 2004

20 November 2004

Quick facts

Lead sponsor	Shire
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	86
Start date	14 June 2004
Primary completion	20 November 2004
Estimated completion	20 November 2004

Drugs / interventions tested

SPD465 — full drug profile →
Immediate Release Amphetamine Salt — full drug profile →
Placebo

Conditions studied

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

Sponsor

Shire — full company profile →

Who can join

Adults 18 to 55, any sex, with Attention-Deficit/Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase 2, randomized, multi-center, double-blind, 3-period and 3-treatment crossover study designed to evaluate the safety and duration of efficacy of SPD465 (50 or 75 mg) compared with placebo and an immediate release amphetamine salt formulation (25 mg) in adults with ADHD. The controlled environment used in this study is an analog classroom setting adapted for a 16-hour adult day.

Publications & conference data

3 peer-reviewed publications 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
A randomized, double-blind study of SHP465 mixed amphetamine salts extended-release in adults with ADHD using a simulated adult workplace design.
Wigal T, Brams M, Frick G, Yan B, et al · · 2018 · cited 9× · PMID 29809075 · DOI 10.1080/00325481.2018.1481712
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 trials of SPD465

Trials testing the same drug.

NCT00458445 — A Study of SPD465 in Young Adult Drivers With Attention-Deficit Hyperactivity Disorder (ADHD) Using Driving Simulators · Phase 3 · withdrawn

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 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 NCT00928148 (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: 3 June 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/NCT00928148.

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