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Safety and Efficacy Study of Sivopixant, Acetazolamide and SASS-001 in Sleep Apnea

StatusActive, Not Recruiting
PhasePhase 2
SponsorShionogi
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Apnimed to Shionogi
    • Primary and study completion dates: Dec 2025 to Dec 31, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 9 of 9 sites
    v13
  2. Study sites: 8 to 9v12
  3. Study sites: 7 to 8v11
  4. Study sites: 6 to 7v10
  5. Eligibility criteria shortened, about 20 wordsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 5 to 6
    • Eligibility criteria expanded, about 605 words
    v8
  2. Trial status: Enrolling by Invitation to Recruiting
    • Site details revised at 5 of 5 sites
    v7
  3. Study sites: 4 to 5v6
  4. Trial status: Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Feb 2025 to Apr 2, 2025
    • Site details revised at 4 of 4 sites
    v5
  5. Study sites: 1 to 4
    • Start date: Jan 2025 to Feb 2025
    v4
  6. Primary endpoint revised
    • Secondary endpoint revised
    v3
  7. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary endpoint revised
    • Study sites: 0 to 1
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoint revised
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Shionogi
45 trials monitored
See 2 trials at risk
The primary purpose of this study is to evaluate the effectiveness of sivopixant, acetazolamide and SASS-001 in adults with sleep apnea with a central component.
Trial Details
NCT Number NCT06776432
Lead Sponsor Shionogi
Conditions
(from sponsor)		 Sleep Apnea
Related terms Sleep Apnea Syndromes, Sleep Apnea, Central, Sleep Apnea, Obstructive
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov