trial

A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.

NCTId NCT04115319
as of 2026-07-01
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at a glance
Phase 3 · Completed
Enrollment 305 (actual)
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Primary completion 2022-12-30
Synthesized from structured facts only — each point cited above.

Design & status

Phase
Phase 3
Status
Completed
Enrollment
305 (actual)
Study type
Interventional
Allocation
Randomized
Model
Parallel
Masking
Quadruple
Start
2019-11-21
Primary completion
2022-12-30
Eligibility
ALL · 18 Years · 65 Years

Interventions & indications

Drugs
UlotarontQuetiapine

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor

Sites

42 total
Cerritos, United StatesOakland, United StatesOceanside, United StatesSan Diego, United StatesTorrance, United StatesMiami, United StatesMiami Lakes, United StatesAtlanta, United StatesHoffman Estates, United StatesLincolnwood, United StatesShreveport, United StatesSt Louis, United States

Linked catalysts

1
A Study of the Long-term Safety and Tolerability of an Investigational Drug in P — primary completion2022-12-30

Facts & assertions

4 sourced
Enrollment
305
Phase
PHASE3
Primary Completion Date
2022-12-30
Status
COMPLETED
relationships
The graph out of here
drug
Ulotaront
drug
Quetiapine
drug
lead_sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
company
indication
Schizophrenia
indication
Schizophrenia
indication