deltatrials
Terminated PHASE3 INTERVENTIONAL 1-arm NCT00750919

Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)

A Twenty-six Weeks, Open-label Extension Trial to Evaluate Safety and Efficacy of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia Who Completed Clinical Trial Protocol 21106

Sponsor: Merck Sharp & Dohme LLC

Interventions esmirtazapine
Updated 14 times since 2017 Last updated: Jan 19, 2021 Started: Oct 7, 2008 Primary completion: Mar 10, 2010 Completion: Mar 10, 2010
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

This trial was stopped prematurely due to the Sponsor's decision not to continue the development of esmertazapine for this indication.

A PHASE3 clinical study on Dyssomnias and Mental Disorders, this trial is terminated or withdrawn. The trial is conducted by Merck Sharp & Dohme LLC and has accumulated 14 data snapshots since 2008. Psychiatric clinical trials are essential for establishing evidence-based treatment standards.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Aug 2017 · 6 months · monthly snapshot~Aug 2017 – ~May 2018 · 9 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Nov 2018 · 5 months · monthly snapshot~Nov 2018 – ~Nov 2020 · 24 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Dec 2021 · 9 months · monthly snapshot~Dec 2021 – ~Jun 2022 · 6 months · monthly snapshot~Jun 2022 – ~Jul 2024 · 25 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 19 months · monthly snapshot~Jan 2026 – present · 3 months · monthly snapshot

Change History

14 versions recorded
  1. Jan 2026 — Present [monthly]

    Terminated PHASE3

  2. Sep 2024 — Present [monthly]

    Terminated PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  4. Jun 2022 — Jul 2024 [monthly]

    Terminated PHASE3

  5. Dec 2021 — Jun 2022 [monthly]

    Terminated PHASE3

Show 9 earlier versions
  1. Mar 2021 — Dec 2021 [monthly]

    Terminated PHASE3

  2. Jan 2021 — Mar 2021 [monthly]

    Terminated PHASE3

  3. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE3

  4. Nov 2018 — Nov 2020 [monthly]

    Terminated PHASE3

  5. Jun 2018 — Nov 2018 [monthly]

    Terminated PHASE3

  6. May 2018 — Jun 2018 [monthly]

    Terminated PHASE3

  7. Aug 2017 — May 2018 [monthly]

    Terminated PHASE3

  8. Feb 2017 — Aug 2017 [monthly]

    Terminated PHASE3

  9. Jan 2017 — Feb 2017 [monthly]

    Terminated PHASE3

    First recorded

Oct 2008

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Merck Sharp & Dohme LLC
Data source: Merck Sharp & Dohme LLC

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

Study Locations

No location information available.