Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04716231 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.
NotablePrimary endpoint(s) modifiedResults posted: Oct 1, 2026 · Final enrollment: 428 participants (planned 376) · Eligibility criteria expanded, about 11 words · 2 moreShow 5 more changesShow less
Results posted: Oct 1, 2026
Final enrollment: 428 participants (planned 376)
Eligibility criteria expanded, about 11 words
Secondary endpoints shortened, about 10 words
Publications: details revised at 3 of 3 entries
NotableStart date: May 23, 2023 to Jun 29, 2023v26
MinorPrimary completion date changed from estimate of May 2025 to May 15, 2025v25
NotablePhase: Phase 2/3 to Phase 3Primary endpoints: 2 to 1 · Enrollment target: 492 to 376 · Study sites: 82 to 1 · 4 morev17Show 7 more changesShow less
NotablePhase: Phase 2 to Phase 2/3Trial status: Active, Not Recruiting to Recruiting · Enrollment target: 116 to 492 · Primary completion date: Mar 2023 to Jun 2025 · 8 morev16Show 11 more changesShow less
Trial status: Active, Not Recruiting to Recruiting
MinorPrimary completion date: Dec 2022 to Mar 2023v15
MinorTrial status: Recruiting to Active, Not RecruitingEnrollment target: estimated 105 to confirmed 116 · Site details revised at 76 of 76 sitesv14Show 2 more changesShow less
Enrollment target: estimated 105 to confirmed 116
Site details revised at 76 of 76 sites
MinorStudy sites: 75 to 76v13
MinorStudy sites: 64 to 75v12
MinorStudy sites: 60 to 64v11
MinorStudy sites: 57 to 60v10
MinorStudy sites: 54 to 57v9
MinorStudy sites: 48 to 54v8
MinorStudy sites: 47 to 48v7
MinorStudy sites: 35 to 47Eligibility criteria shortened, about 8 wordsv6Show 1 more changeShow less
NotableTrial status: Not Yet Recruiting to RecruitingPrimary endpoint revised · Study sites: 0 to 3 · Start date changed from estimate of Apr 2021 to May 18, 2021 · 3 morev2Show 6 more changesShow less
Primary endpoint revised
Study sites: 0 to 3
Start date changed from estimate of Apr 2021 to May 18, 2021
Stopped: an ongoing trial was terminated, suspended or withdrawn.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.