deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT02750306

Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Participants With Alzheimer's Disease (MK-4305-061)

A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Subjects With Alzheimer's Disease

Sponsor: Merck Sharp & Dohme LLC

Conditions Alzheimer Disease Sleep Initiation and Maintenance Disorders
Interventions Placebo Suvorexant
Updated 19 times since 2017 Last updated: Sep 25, 2019 Started: May 23, 2016 Primary completion: Sep 30, 2018 Completion: Sep 30, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02750306, this PHASE3 trial focuses on Alzheimer Disease and Sleep Initiation and Maintenance Disorders and remains completed. Sponsored by Merck Sharp & Dohme LLC, it has been updated 19 times since 2016, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~May 2017 · 3 months · monthly snapshot~May 2017 – ~Jun 2017 · 31 days · monthly snapshot~Jun 2017 – ~Aug 2017 · 2 months · monthly snapshot~Aug 2017 – ~Sep 2017 · 31 days · monthly snapshot~Sep 2017 – ~Oct 2017 · 30 days · monthly snapshot~Oct 2017 – ~Dec 2017 · 2 months · monthly snapshot~Dec 2017 – ~Jan 2018 · 31 days · monthly snapshot~Jan 2018 – ~Feb 2018 · 31 days · monthly snapshot~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Sep 2018 · 2 months · monthly snapshot~Sep 2018 – ~Nov 2018 · 2 months · monthly snapshot~Nov 2018 – ~Nov 2019 · 12 months · monthly snapshot~Nov 2019 – ~Jan 2021 · 14 months · monthly snapshot~Jan 2021 – ~Jun 2022 · 17 months · monthly snapshot~Jun 2022 – ~Jul 2024 · 25 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 22 months · monthly snapshot

Change History

19 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. Jun 2022 — Jul 2024 [monthly]

    Completed PHASE3

  4. Jan 2021 — Jun 2022 [monthly]

    Completed PHASE3

  5. Nov 2019 — Jan 2021 [monthly]

    Completed PHASE3

▶ Show 14 earlier versions

  1. Nov 2018 — Nov 2019 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  2. Sep 2018 — Nov 2018 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  3. Jul 2018 — Sep 2018 [monthly]

    Recruiting PHASE3

  4. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE3

  5. Feb 2018 — Jun 2018 [monthly]

    Recruiting PHASE3

  6. Jan 2018 — Feb 2018 [monthly]

    Recruiting PHASE3

  7. Dec 2017 — Jan 2018 [monthly]

    Recruiting PHASE3

  8. Oct 2017 — Dec 2017 [monthly]

    Recruiting PHASE3

  9. Sep 2017 — Oct 2017 [monthly]

    Recruiting PHASE3

  10. Aug 2017 — Sep 2017 [monthly]

    Recruiting PHASE3

  11. Jun 2017 — Aug 2017 [monthly]

    Recruiting PHASE3

  12. May 2017 — Jun 2017 [monthly]

    Recruiting PHASE3

  13. Feb 2017 — May 2017 [monthly]

    Recruiting PHASE3

  14. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

May 2016

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.