Phase 3
Completed N=43
Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031
Source: ClinicalTrials.gov NCT00174447 ↗Enrolled (actual)
43
Serious AEs
30.2%
Results posted
Nov 2009
Primary outcomePrimary: Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) — 13; 30; 10; 20 participants
Summary
Open label extension study of Ziprasidone, evaluation of safety of long term use of ziprasidone
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) |
13; 30; 10; 20; 2; 3 | — |
| PRIMARY Change From Baseline in CGI-I at End of Study (up to 5 Years) |
1.4 | — |
| PRIMARY Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) |
4; 20; 14; 4; 1; 6 | — |
| PRIMARY Change From Baseline in CGI-S at End of Study (up to 5 Years) |
0.9 | — |
| SECONDARY Number of Participants With Scores on Patient Preference Scale (PPS) |
28; 13; 2; 4; 8; 8 | — |
| SECONDARY Change From Baseline in Drug Attitude Inventory (DAI) at End of Study (up to 5 Years) |
-3.3 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who successfully completed study A1281031 (CGI score of 1 or 2 at final visit) or ZIP-NY-98035 and with QTc <= 500 msec.
Exclusion Criteria
- All other patients who do not fit the inclusion criteria as stated above.
Data sourced from ClinicalTrials.gov (NCT00174447). 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. Informational only — not medical advice.