Trial · NCT00856583
Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use
NCT00856583, Phase 3, Completed, H. Lundbeck A/S; results first posted 2011-08-01
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ConductScience Library. Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use. Trials, record NCT00856583. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00856583
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use
- NCT number
- NCT00856583
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 9,809 participants, actual
- Lead sponsor
- H. Lundbeck A/S
- Conditions
- Schizophrenia
- Interventions
- Sertindole, Risperidone
- First posted
- 2009-03-06
- Last updated
- 2011-08-19
- Other registries' IDs
- eudract:2004-000213-19
- Results first posted
- 2011-08-01
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With All-cause Mortality | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis was based on all deaths from the Whole Randomised Treatment (WRT)+30 days period and the Only Randomised Treatment (ORT) period, respectively |
| Primary | Second Primary Outcome: Number of Participants With Cardiac Events, Including Arrhythmias, Requiring Hospitalisation | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | Second primary endpoint: a serious adverse event where the patient was hospitalised and for which the Independent Safety Committee (ISC) classified the event as a cardiac event with documented arrhythmia. The analysis of this outcome was not performed due to low number of events. The presented analysis is a replacement analysis using all cardiac events, including arrhythmias, that required hospitalisation |
| Secondary | Cause-specific Mortality: Number of Participants With Cardiac Deaths - ISC | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide. |
| Secondary | Cause-specific Mortality: Number of Participants With Completed Suicides - ISC | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide. |
| Secondary | Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - ISC | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide. |
| Secondary | Cause-specific Mortality: Number of Participants With Cardiac Deaths - MedDRA | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis was based on all deaths from the WRT+30 days period using the classification based upon the Medical Dictionary for Regulatory Activities (MedDRA) terminology, that is, as reported by the investigator |
| Secondary | Cause-specific Mortality: Number of Participants With Completed Suicides - MedDRA | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis was based on all deaths from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator |
| Secondary | Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - MedDRA | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis was based on all deaths from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator |
| Secondary | Number of Participants With Suicide Attempts (Fatal and Non-fatal) - ISC | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis was based on all suicides and suicide attempts from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide. |
| Secondary | Number of Participants With Suicide Attempts (Fatal and Non-fatal) - MedDRA | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis was based on all suicides and suicide attempts from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With All-cause Mortality | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis population included all patients who took at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Cause-specific Mortality: Number of Participants With Cardiac Deaths - ISC | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis population included all patients who took at least one dose of study drug. | participants | NUMBER |
| PRIMARY | Second Primary Outcome: Number of Participants With Cardiac Events, Including Arrhythmias, Requiring Hospitalisation | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis population included all patients who took at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Cause-specific Mortality: Number of Participants With Completed Suicides - ISC | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | participants | NUMBER | |
| SECONDARY | Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - ISC | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | participants | NUMBER | |
| SECONDARY | Cause-specific Mortality: Number of Participants With Cardiac Deaths - MedDRA | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | participants | NUMBER | |
| SECONDARY | Cause-specific Mortality: Number of Participants With Completed Suicides - MedDRA | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | participants | NUMBER | |
| SECONDARY | Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - MedDRA | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | participants | NUMBER | |
| SECONDARY | Number of Participants With Suicide Attempts (Fatal and Non-fatal) - ISC | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis population included all patients who took at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Suicide Attempts (Fatal and Non-fatal) - MedDRA | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With All-cause Mortality | Sertindole | Number of deaths (WRT+30 days) | 64 | participants | |
| Number of Participants With All-cause Mortality | Risperidone | Number of deaths (WRT+30 days) | 61 | participants | |
| Number of Participants With All-cause Mortality | Sertindole | Number of deaths (ORT) | 40 | participants | |
| Number of Participants With All-cause Mortality | Risperidone | Number of deaths (ORT) | 44 | participants | |
| Cause-specific Mortality: Number of Participants With Cardiac Deaths - ISC | Sertindole | 31 | participants | ||
| Cause-specific Mortality: Number of Participants With Cardiac Deaths - ISC | Risperidone | 12 | participants | ||
| Second Primary Outcome: Number of Participants With Cardiac Events, Including Arrhythmias, Requiring Hospitalisation | Sertindole | 10 | participants | ||
| Second Primary Outcome: Number of Participants With Cardiac Events, Including Arrhythmias, Requiring Hospitalisation | Risperidone | 6 | participants | ||
| Cause-specific Mortality: Number of Participants With Completed Suicides - ISC | Sertindole | 14 | participants | ||
| Cause-specific Mortality: Number of Participants With Completed Suicides - ISC | Risperidone | 21 | participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sertindole | 4,905 | |
| Overall Study | STARTED | Risperidone | 4,904 | |
| Overall Study | COMPLETED | Sertindole | 1,768 | |
| Overall Study | COMPLETED | Risperidone | 2,307 | |
| Overall Study | NOT COMPLETED | Sertindole | 3,137 | |
| Overall Study | NOT COMPLETED | Risperidone | 2,597 |
Source ClinicalTrials.gov
Adverse events542
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 | Electrocardiogram QT prolonged | Investigations | Sertindole | 397 | 4,905 | |
| other | Electrocardiogram QT prolonged | Investigations | Risperidone | 11 | 4,904 | |
| serious | Anaemia | Blood and lymphatic system disorders | Sertindole | 2 | 4,905 | 2 |
| serious | Anaemia | Blood and lymphatic system disorders | Risperidone | 3 | 4,904 | 3 |
| serious | Blood disorder | Blood and lymphatic system disorders | Sertindole | 1 | 4,905 | 1 |
| serious | Blood disorder | Blood and lymphatic system disorders | Risperidone | 0 | 4,904 | 0 |
| serious | Leukopenia | Blood and lymphatic system disorders | Sertindole | 2 | 4,905 | 2 |
| serious | Leukopenia | Blood and lymphatic system disorders | Risperidone | 0 | 4,904 | 0 |
| serious | Normochromic normocytic anaemia | Blood and lymphatic system disorders | Sertindole | 0 | 4,905 | 0 |
| serious | Normochromic normocytic anaemia | Blood and lymphatic system disorders | Risperidone | 1 | 4,904 | 1 |
1 to 10 of 542Source ClinicalTrials.gov
See all 542 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sertindole | ||
| Total, all-cause mortality | Risperidone | ||
| Total, other adverse events | Sertindole | 397 | 4,905 |
| Total, other adverse events | Risperidone | 11 | 4,904 |
| Total, serious adverse events | Sertindole | 266 | 4,905 |
| Total, serious adverse events | Risperidone | 217 | 4,904 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons12
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sertindole vs Risperidone: Number of Participants With Suicide Attempts (Fatal and Non-fatal) - MedDRA | Trial comparisons |
| Sertindole vs Risperidone: Cause-specific Mortality: Number of Participants With Cardiac Deaths - MedDRA | Trial comparisons |
| Sertindole vs Risperidone: Cause-specific Mortality: Number of Participants With Cardiac Deaths - ISC | Trial comparisons |
| Sertindole vs Risperidone: Cause-specific Mortality: Number of Participants With Completed Suicides - MedDRA | Trial comparisons |
| Sertindole vs Risperidone: Number of Participants With Suicide Attempts (Fatal and Non-fatal) - ISC | Trial comparisons |
| Sertindole vs Risperidone: Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - MedDRA | Trial comparisons |
| Sertindole vs Risperidone: Number of Participants With Discontinuation of Treatment for Any Reason Other Than Study Closure | Trial comparisons |
| Sertindole vs Risperidone: Number of Participants With Hospitalisations, Excluding Hospitalisations Related to the Primary Psychiatric Disease | Trial comparisons |
| Sertindole vs Risperidone: Second Primary Outcome: Number of Participants With Cardiac Events, Including Arrhythmias, Requiring Hospitalisation | Trial comparisons |
| Sertindole vs Risperidone: Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - ISC | Trial comparisons |
1 to 10 of 12
See all 12 trial comparisonsTests0
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/NCT00856583
GET https://conductscience.org/api/trials/v1/NCT00856583/results?page=2