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NCT00202605

Safety and Efficacy of SPD465 in Adults With ADHD

Completed Phase 2 Last updated 24 June 2021
What this trial tests

Phase 2 trial testing Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate in Attention Deficit Disorder With Hyperactivity in 72 participants. Completed in 6 January 2006.

Timeline
29 September 2005
Primary endpoint
6 January 2006
6 January 2006

Quick facts

Lead sponsorShire
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Enrollment72
Start date29 September 2005
Primary completion6 January 2006
Estimated completion6 January 2006
Sites4 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Shire — full company profile →

Who can join

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

Sponsor's own description

The purpose of the study is to evaluate how safe and how well SPD465 works compared to placebo in adults with ADHD. It is hypothesized that SPD465 will achieve an extended duration of clinical benefit.

Publications & conference data

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

  1. 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
  2. Effects of SHP465 mixed amphetamine salts in adults with ADHD in a simulated adult workplace environment.
    Wigal T, Childress A, Frick G, Yan B, et al · · 2018 · cited 10× · PMID 29087231 · DOI 10.1080/00325481.2018.1389227

Verify or expand the search:

Other recruiting trials for Attention Deficit Disorder With Hyperactivity

Currently open trials in the same condition.

Other Shire trials

Trials by the same sponsor.

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Data sources for this page

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