PRX Research | Mesquite, TX
Status and phase
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About
This is an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305, which also allows participants from the Phase 2 Study 12-AVR-131 to be included.
Full description
Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305.
Participants will be enrolled in the study for approximately 56 weeks (participants who have a follow-up visit 3 months after the last dose of treatment will be enrolled for approximately 64 weeks).
Approximately 1200 participants will be enrolled at approximately 250 centers globally.
All participants enrolled will receive AVP-786; the treatment dose assigned will be masked to the participant, investigator, study staff, and the sponsor.
Enrollment
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Allocation
Interventional model
Masking
1,197 participants in 3 patient groups
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Central trial contact
Otsuka Call Center
Data sourced from clinicaltrials.gov
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