Phase 3
N=117
Aripiprazole for Schizophrenia Outpatients Completing BMS Clinical Trials
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00239356 ↗Enrolled (actual)
117
Serious AEs
11.1%
Results posted
Jan 2014
Primary outcome: Primary: Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population. — 2.6; 1.0; 2.3; 1.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aripiprazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population. |
2.6; 1.0; 2.3; 1.1; 2.3; 1.1 | — |
| SECONDARY Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to an AE - Safety Population |
0; 0; 13; 0; 47; 14 | — |
| SECONDARY Mean Exposure to Aripiprazole at Days 541 to 630, Days 721 to 810 and Days 1081 to 1170 - Safety Population |
20.25; 13.53; 20.55; 13.67; 23.20; 14.7 | — |
| SECONDARY Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population |
4; 0; 1; 0; 1; 0 | — |
| SECONDARY Number of Participants With Potentially Clinically Relevant Hematology Laboratory Abnormalities During Treatment - Safety Population |
1; 3; 1; 1; 2; 1 | — |
| SECONDARY Number of Participants With Potentially Clinically Relevant Vital Sign Abnormality During Treatment - Safety Population |
3; 0; 1; 0; 1; 0 | — |
| SECONDARY Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population |
0; 1; 1; 1; 0; 1 | — |
Summary
The purpose of this study is to provide aripiprazole to schizophrenic outpatients and Community Treated Patients who are currently receiving aripiprazole therapy on another BMS sponsored clinical trial.
Eligibility Criteria
Inclusion Criteria
- Currently receiving aripiprazole at time of screening
- Men and women ages 18 to 70
Exclusion Criteria
- All patients previously discontinued from an aripiprazole study for any reason
- Active alcohol or substance abuse
- Patients who represent a significant risk of committing suicide
- Patients with clinically significant abnormal laboratory test results, vital signs or ECG findings
Data sourced from ClinicalTrials.gov (NCT00239356). 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.