Phase 2
N=98
Safety and Tolerability Study of Drug to Treat Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00044005 ↗Enrolled (actual)
98
Serious AEs
12.2%
Results posted
May 2011
Primary outcome: Primary: Number of Participants With Adverse Events — 19; 22; 18 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lurasidone 20 mg (Drug); Lurasidone 40 mg (Drug); Lurasidone 80mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sumitomo Pharma America, Inc.
- Primary completion
- Nov 2003
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
19; 22; 18 | — |
Summary
The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with schizophrenia.
Eligibility Criteria
Inclusion criteria
- Successful completion of participation in protocol #D1050049
Exclusion criteria
- Substance abuse
- Prolactin level of ≥200ng/mL at baseline
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT00044005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.