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NOT YET RECRUITING
NCT06649214
PHASE3

A Study of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

DRUG

Olanzapine-samidorphan;

orally once daily, tablet, 10mg/10mg、15mg/10mg or 20mg/10mg,duration of 24 weeks.

DRUG

Olanzapine

orally once daily, tablet, 10mg、15mg or 20mg,duration of 24 weeks.