Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Long-Term Safety of Paliperidone Palmitate in Japanese Schizophrenia Patients
NCT01258920Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2010
- Primary completion
- Nov 2012
- Countries
- 1
- Sponsor
- Janssen Pharmaceutical
- Modality
- Metabolically Activated Prodrugs
- Conditions
- schizophrenia
01
Overview
Phase 3, open-label, single-arm trial of paliperidone palmitate in schizophrenia, sponsored by Janssen Pharmaceutical. Primary endpoint: Incidence of adverse events at 49 weeks. Started Oct 2010; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Paliperidone palmitate
Open-label paliperidone palmitate IM injection.
03
Who it enrols
Japanese patients aged 20 or older with schizophrenia, PANSS score 60-120, and documented tolerability to risperidone or paliperidone.
04
Endpoints
Primary
Incidence of adverse events
Secondary
Change from baseline in Positive and Negative Syndrome Scale total score
Change from baseline in Clinical Global Impression - Severity score
Pharmacokinetic evaluations
Beyond the preview
Go deeper on NCT01258920.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT01258920.