NCT01819818

A Study to Observe the Safety and Tolerability of Paliperidone Palmitate (Invega Sustenna) in Korean Schizophrenic Patients

Korea Post-Marketing Surveillance of Invega Sustenna

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,267 (actual)
• Sponsor: Janssen Korea, Ltd., Korea · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of paliperidone palmitate over a 9-week period for participants with schizophrenia in Korea.

Detailed description

This is an open-label (all people know the identity of the intervention), multi-center, prospective (look forward using observations collected following participant enrollment), non-comparative, non-randomized (the study medication is not assigned by chance), study. Safety and efficacy of paliperidone palmitate will be observed in Korean schizophrenic participants for 25 weeks. Approximately 3000 participants will be observed in this study and the study duration will be 25 weeks. Safety evaluations will include assessment of adverse events, concomitant medications, physical examination, and psychiatric history.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	No intervention	This is an observational study. Korean schizophrenic participants receiving paliperidone palmitate as an intramuscular injections will be observed.

Timeline

• Start date: 2011-05-23
• Primary completion: 2019-11-29
• Completion: 2019-11-29
• First posted: 2013-03-28
• Last updated: 2025-04-27

Locations

1 site across 1 country: South Korea