Trial · NCT00641745
Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia
NCT00641745, Phase 3, Completed, Sumitomo Pharma America, Inc.; results first posted 2011-10-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia. Trials, record NCT00641745. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00641745
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia
- NCT number
- NCT00641745
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 629 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Interventions
- Lurasidone HCl, Risperidone
- First posted
- 2008-03-24
- Last updated
- 2015-06-22
- Results first posted
- 2011-10-06
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events. | 12 months |
Source ClinicalTrials.gov
Outcomes1
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 Adverse Events. | 12 months | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
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 Adverse Events. | Lurasidone | 395 | participants | ||
| Number of Participants With Adverse Events. | Risperidone | 189 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lurasidone | 427 | |
| Overall Study | STARTED | Risperidone | 202 | |
| Overall Study | COMPLETED | Lurasidone | 147 | |
| Overall Study | COMPLETED | Risperidone | 89 | |
| Overall Study | NOT COMPLETED | Lurasidone | 280 | |
| Overall Study | NOT COMPLETED | Risperidone | 113 |
Source ClinicalTrials.gov
Adverse events124
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 | Constipation | Gastrointestinal disorders | Lurasidone | 8 | 419 | 8 |
| other | Constipation | Gastrointestinal disorders | Risperidone | 14 | 202 | 14 |
| other | Nausea | Gastrointestinal disorders | Lurasidone | 70 | 419 | 70 |
| other | Nausea | Gastrointestinal disorders | Risperidone | 22 | 202 | 22 |
| other | Vomiting | Gastrointestinal disorders | Lurasidone | 42 | 419 | 42 |
| other | Vomiting | Gastrointestinal disorders | Risperidone | 7 | 202 | 7 |
| other | Nasopharyngitis | Infections and infestations | Lurasidone | 22 | 419 | 22 |
| other | Nasopharyngitis | Infections and infestations | Risperidone | 13 | 202 | 13 |
| other | Weight Decreased | Investigations | Lurasidone | 31 | 419 | 31 |
| other | Weight Decreased | Investigations | Risperidone | 9 | 202 | 9 |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lurasidone | ||
| Total, all-cause mortality | Risperidone | ||
| Total, other adverse events | Lurasidone | 349 | 419 |
| Total, other adverse events | Risperidone | 169 | 202 |
| Total, serious adverse events | Lurasidone | 46 | 419 |
| Total, serious adverse events | Risperidone | 20 | 202 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lurasidone vs Risperidone: Number of Participants With Adverse Events. | Trial comparisons |
| Lurasidone vs Risperidone: serious adverse events | Trial comparisons |
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/NCT00641745
GET https://conductscience.org/api/trials/v1/NCT00641745/events?page=2