Investigate Efficacy, Safety, and Pharmacokinetics of Enzastaurin for the Prevention of Arterial Events in Patients With Vascular Ehlers-Danlos Syndrome.
← catalyst calendarSponsored by Aytu BioPharma, Inc. (industry) · AYTU — their whole pipeline →. With Parexel.
Phase
Phase 3
Status
Suspended
Study type
Interventional
Design
Randomized · Triple · Prevention
Enrollment
260estimated
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Indefinite hold by company
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | Jan 2025 | estimated | When the study began enrolling |
| Primary completion | Jun 2025 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2022-07-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2024-03-08 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Vascular Ehlers-Danlos Syndrome
Interventions
- Drug: Enzastaurin
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFTime to intervention for an arterial event (rupture, dissection, pseudoaneurysm, carotid-cavernous sinus fistula, or aneurysm, fatal or not) or mortality attributable to an arterial event.
measured 30 months
Publications
- PMID 31639107 — cited as background
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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