Trial · NCT01053429
A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule
NCT01053429, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2011-01-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule. Trials, record NCT01053429. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01053429
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule
- NCT number
- NCT01053429
- Status
- Completed
- Enrollment
- 3,391 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Bipolar Disorder, Schizophrenia
- Interventions
- ziprasidone
- First posted
- 2010-01-21
- Last updated
- 2021-03-03
- Results first posted
- 2011-01-07
- Limitations and caveats
Per the Statistical Analysis Plan Amendment CGI-S and CGI-I endpoints analyzed as frequency counts (categorical) rather than the planned CGI-S mean change from baseline and CGI-I mean scores (continuous); any additional analyses would be exploratory.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population | Baseline up to Week 8 | CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected. |
| Primary | Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population | Baseline up to Week 8 | CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected. |
| Primary | Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - ITT | Baseline up to Week 8 | CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected. |
| Primary | Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - PP | Baseline up to Week 8 | CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected. |
| Other | Change From Baseline in Brief Psychiatric Rating Scale (BPRS ) - Improvement | Baseline up to Week 8 | BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, and excitement. Ratings anchored to improve consistency for a single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology. |
| Other | Change From Baseline in Drug Attitude Inventory (DAI-10) - Improvement | Baseline up to Week 8 | DAI-10: a 10-item scale to assess how the attitude of participants with schizophrenia toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranges from -10 to 10, where a positive score indicates a positive subjective response (compliant); a negative score indicates non-compliance. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population | Baseline up to Week 8 | Intent to treat population (ITT): administered at least 1 dose of study treatment at least once a week and observed for at least 1 efficacy assessment. N=number of participants with evaluable data at observation. Efficacy analysis planned for CGI-S at each visit but completed at last visit (no set schedule for study visits). | particpants | NUMBER |
| PRIMARY | Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population | Baseline up to Week 8 | Per Protocol population (PP): participants in ITT group with study treatment for at least 8 (± 1 week) since enrollment and observed for final efficacy (inpatient visit or phone call). N=participants with evaluable data at observation. Efficacy analysis planned for CGI-S at each visit but completed at last visit (no set schedule for study visits). | participants | NUMBER |
| PRIMARY | Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - ITT | Baseline up to Week 8 | ITT; N=number of participants with evaluable data at observation. Efficacy analysis planned for CGI-I at each visit but completed at last visit (no set schedule for study visits). | participants | NUMBER |
| PRIMARY | Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - PP | Baseline up to Week 8 | PP; N=number of participants with evaluable data at observation. Efficacy analysis planned for CGI-I at each visit but completed at last visit (no set schedule for study visits). | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Change From Baseline in Brief Psychiatric Rating Scale (BPRS ) - Improvement | Baseline up to Week 8 | Safety analysis set: all participants who received at least 1 dose of study treatment. It was recommended to use the optional BPRS tool to gather additional information for the improvement score under usual practice. The optional BPRS tool was not used during the study. | ||
| OTHER_PRE_SPECIFIED | Change From Baseline in Drug Attitude Inventory (DAI-10) - Improvement | Baseline up to Week 8 | Safety analysis set. It was recommended to use the optional DAI-10 tool to gather additional information for the improvement score under usual practice. The optional DAI-10 tool was not used during the study. |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population | Ziprasidone HCl (Zeldox) | Normal, not ill at all | 190 | particpants | |
| Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population | Ziprasidone HCl (Zeldox) | Borderline mentally ill | 1125 | particpants | |
| Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population | Ziprasidone HCl (Zeldox) | Mildly ill | 1325 | particpants | |
| Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population | Ziprasidone HCl (Zeldox) | Moderately ill | 506 | particpants | |
| Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population | Ziprasidone HCl (Zeldox) | Markedly ill | 156 | particpants | |
| Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population | Ziprasidone HCl (Zeldox) | Severely ill | 46 | particpants | |
| Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population | Ziprasidone HCl (Zeldox) | Among the most extremely ill | 3 | particpants | |
| Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population | Ziprasidone HCl (Zeldox) | Normal, not ill at all | 130 | participants | |
| Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population | Ziprasidone HCl (Zeldox) | Borderline mentally ill | 815 | participants | |
| Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population | Ziprasidone HCl (Zeldox) | Mildly ill | 889 | participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ziprasidone HCl (Zeldox) | 3,391 | |
| Overall Study | COMPLETED | Ziprasidone HCl (Zeldox) | 3,018 | |
| Overall Study | NOT COMPLETED | Ziprasidone HCl (Zeldox) | 373 |
Source ClinicalTrials.gov
Adverse events64
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Leukopenia | Blood and lymphatic system disorders | Ziprasidone HCl (Zeldox) | 1 | 3,391 | |
| other | Palpitations | Cardiac disorders | Ziprasidone HCl (Zeldox) | 2 | 3,391 | |
| other | Tachycardia | Cardiac disorders | Ziprasidone HCl (Zeldox) | 1 | 3,391 | |
| other | Abdominal pain | Gastrointestinal disorders | Ziprasidone HCl (Zeldox) | 2 | 3,391 | |
| other | Constipation | Gastrointestinal disorders | Ziprasidone HCl (Zeldox) | 13 | 3,391 | |
| other | Dyspepsia | Gastrointestinal disorders | Ziprasidone HCl (Zeldox) | 4 | 3,391 | |
| other | Gastrointestinal disorder | Gastrointestinal disorders | Ziprasidone HCl (Zeldox) | 1 | 3,391 | |
| other | Nausea | Gastrointestinal disorders | Ziprasidone HCl (Zeldox) | 24 | 3,391 | |
| other | Salivary hypersecretion | Gastrointestinal disorders | Ziprasidone HCl (Zeldox) | 1 | 3,391 | |
| other | Vomiting | Gastrointestinal disorders | Ziprasidone HCl (Zeldox) | 4 | 3,391 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ziprasidone HCl (Zeldox) | ||
| Total, other adverse events | Ziprasidone HCl (Zeldox) | 392 | 3,391 |
| Total, serious adverse events | Ziprasidone HCl (Zeldox) | 2 | 3,391 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01053429
GET https://conductscience.org/api/trials/v1/NCT01053429/results?page=2