deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT00784654

Double-blind, Placebo-controlled, Randomised Withdrawal, Extension, Safety and Efficacy Study of LDX in Children and Adolescents Aged 6-17

A Phase III, Double-blind, Placebo-controlled, Randomised Withdrawal, Multicentre, Extension, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention- Deficit/Hyperactivity Disorder (ADHD)

Sponsor: Shire

Conditions ADHD
Updated 8 times since 2017 Last updated: May 25, 2021 Started: Jan 27, 2009 Primary completion: Oct 26, 2011 Completion: Oct 26, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on ADHD, this trial is completed. The trial is conducted by Shire and has accumulated 8 data snapshots since 2009. Psychiatric clinical trials are essential for establishing evidence-based treatment standards.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshotCompleted~Sep 2021 – ~Jul 2024 · 34 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Sep 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jan 2021 — Sep 2021 [monthly]

    Completed PHASE3

Show 3 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

  2. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE3

  3. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE3

    First recorded

Jan 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Shire
Data source: Takeda

For direct contact, visit the study record on ClinicalTrials.gov .