A Study to Observe the Safety and Tolerability of Paliperidone Palmitate (Invega Sustenna) in Korean Schizophrenic Patients
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About
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.
Full 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.
Enrollment
Sex
Volunteers
Inclusion criteria
- Participants diagnosed with schizophrenia
- Participants prescribed with paliperidone palmitate for acute or maintenance treatment
Exclusion criteria
- Participants who received paliperidone palmitate for other than the approved indication
Trial design
3,267 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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