deltatrials
Completed PHASE4 INTERVENTIONAL 1-arm NCT00500071

Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD

A Prospective, Open-Label, Multi-Center, Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) 20-70mg in Children Aged 6-12 Diagnosed With ADHD

Sponsor: Shire

Updated 8 times since 2017 Last updated: Feb 25, 2022 Started: Jun 28, 2007 Primary completion: Jan 2, 2008 Completion: Jan 2, 2008
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on Attention Deficit Hyperactivity Disorder (ADHD), this trial is completed. The trial is conducted by Shire and has accumulated 8 data snapshots since 2007. Psychiatric clinical trials are essential for establishing evidence-based treatment standards.

Study Description(click to expand)

Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (lisdexamfetamine dimesylate) in Children aged 6-12 Diagnosed with ADHD

Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (lisdexamfetamine dimesylate) in Children aged 6-12 Diagnosed with ADHD

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 – ~Apr 2022 · 7 months · monthly snapshotCompleted~Apr 2022 – ~Jul 2024 · 27 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE4

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  3. Apr 2022 — Jul 2024 [monthly]

    Completed PHASE4

  4. Sep 2021 — Apr 2022 [monthly]

    Completed PHASE4

  5. Jan 2021 — Sep 2021 [monthly]

    Completed PHASE4

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

    Completed PHASE4

  2. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE4

  3. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE4

    First recorded

Jun 2007

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 .