NCT05168007

Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center, Fixed-Dose, Phase 3 Clinical Trial Evaluating the Efficacy and Safety of WID-RGC20 3 mg/Day and 6 mg/Day in Patients With Acute Psychotic Episode of Schizophrenia

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 342 (estimated)
• Sponsor: Whanin Pharmaceutical Company · Industry
• Sex: All
• Age: 19 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This Study is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center, Fixed-Dose, Phase 3 Clinical Trial Evaluating the Efficacy and Safety of WID-RGC20 3 mg/day and 6 mg/day in Patients with Acute Psychotic Episode of Schizophrenia.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	WID-RGC20(Cariprazine) 3mg/day	The initial dose is WID-RGC20(Cariprazine) 1.5mg/day, followed by an up-titration of 1.5mg/day until the target dose(3mg/day) is achieved. The investigational product is administered during the double-blind treatment period(6 weeks).
DRUG	WID-RGC20(Cariprazine) 6mg/day	The initial dose is WID-RGC20(Cariprazine) 1.5mg/day, followed by an up-titration of 1.5mg/day until the target dose(6mg/day) is achieved. The investigational product is administered during the double-blind treatment period(6 weeks).
DRUG	Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day	The placebo comparator is administered during the double-blind treatment period(6 weeks).

Timeline

• Start date: 2021-11-19
• Primary completion: 2023-07-17
• Completion: 2023-07-31
• First posted: 2021-12-22
• Last updated: 2021-12-22

Locations

1 site across 1 country: South Korea