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NOT YET RECRUITING
NCT06589817
PHASE3

A Double-Blind, Randomized Comparative Study of Carliprazine and Aripiprazole in Patients with Acute Schizophrenia

Sponsor: Chengdu Kanghong Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a non-Inferiority trial to evaluate efficacy and safety of hydrochloride carliprazine capsules and aripiprazole tablets in treating acute schizophrenia in Chinese adults. 376 patients will be randomizdely assigned in a 1:1 ratio to treatment group and control group. All enrolled subjects will be orally administered with hydrochloride carliprazine capsules or aripiprazole tablets for 6 consecutive weeks.

Official title: A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Hydrochloride Carliprazine Capsules or Aripiprazole Tablets for the Treatment of Acute Schizophrenia Subjects

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

376

Start Date

2024-10

Completion Date

2026-12

Last Updated

2024-09-19

Healthy Volunteers

No

Interventions

DRUG

Hydrochloride Carliprazine capsules

Oral administration, once daily, with a total treatment duration of 6 weeks after successful screening.

DRUG

Aripiprazole tablets

Oral administration, once daily, with a total treatment duration of 6 weeks after successful screening.