Trials / Not Yet Recruiting
Not Yet RecruitingNCT06649214
A Study of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia
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
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 654 (estimated)
- Sponsor
- Qilu Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-11-01
- Primary completion
- 2026-04-01
- Completion
- 2026-05-01
- First posted
- 2024-10-18
- Last updated
- 2024-10-21
Source: ClinicalTrials.gov record NCT06649214. Inclusion in this directory is not an endorsement.