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A Study of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia
Sponsor: Qilu Pharmaceutical Co., Ltd.
Summary
The goal of this \[clinical trial\] is to \[evaluate the safety and efficacy of olanzapine-samidorphan tablets\] in \[adults with schizophrenia\]. The main question\[s\] it aims to answer are: * \[question 1\] Olanzapine-samidorphan significantly mitigate weight gain better than olanzapine. * \[question 2\] Olanzapine- samidorphan and olanzapine have similar antipsychotic efficacy.
Official title: A Randomized, Double-blind, Double-dummy, Positive Drug Parallel Controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
654
Start Date
2024-11
Completion Date
2026-05
Last Updated
2024-10-21
Healthy Volunteers
No
Conditions
Interventions
Olanzapine-samidorphan;
orally once daily, tablet, 10mg/10mg、15mg/10mg or 20mg/10mg,duration of 24 weeks.
Olanzapine
orally once daily, tablet, 10mg、15mg or 20mg,duration of 24 weeks.