Trial · NCT00156065
Long-Term Efficacy and Safety of Asenapine Using Haloperidol as a Positive Control (41513)(COMPLETED)(P05785)
NCT00156065, Phase 3, Completed, Organon and Co; results first posted 2010-04-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-Term Efficacy and Safety of Asenapine Using Haloperidol as a Positive Control (41513)(COMPLETED)(P05785). Trials, record NCT00156065. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00156065
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Efficacy and Safety of Asenapine Using Haloperidol as a Positive Control (41513)(COMPLETED)(P05785)
- NCT number
- NCT00156065
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 187 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Schizophrenia
- Interventions
- Haloperidol, Asenapine, Asenapine
- First posted
- 2005-09-12
- Last updated
- 2022-02-08
- Results first posted
- 2010-04-07
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Loss of Effect Over Time | Throughout the 52 weeks of the trial. | Loss of effect in subjects who had \>=30% decrease from baseline in Positive and Negative Syndrome Scale (PANSS) score at the end of the original trial (NCT00156104) preceding the long-term extension. PANSS is a 30-item clinician-rated instrument for assessing symptoms of schizophrenia. Scores range from 30-210; higher scores indicate greater severity. Loss of effect = increase in total PANSS \>=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score \>=6; discontinuation for lack of efficacy. |
| Primary | Median Survival Time of Effect | 52 Weeks | Kaplan-Meier estimate of median time to loss of effect in subjects who had \>=30% decrease from baseline in PANSS score at the end of the original trial (NCT00156104) preceding the long-term extension. PANSS is a 30-item clinician-rated instrument for assessing symptoms of schizophrenia. Scores range from 30-210; higher scores indicate greater severity. Loss of effect = increase in total PANSS \>=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score \>=6; discontinuation for lack of efficacy. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Loss of Effect Over Time | Throughout the 52 weeks of the trial. | These are participants who completed the original acute-phase trial (41023) with a decrease from baseline in Positive and Negative Syndrome Scale (PANSS) score \>= 30%, received at least one dose in the current long-term extension, and had at least one post-baseline PANSS assessment during the extension. | Participants | NUMBER |
| PRIMARY | Median Survival Time of Effect | 52 Weeks | These are participants who completed the original acute-phase trial (41023) with a decrease from baseline in Positive and Negative Syndrome Scale (PANSS) score \>= 30%, received at least one dose in the current long-term extension, and had at least one post-baseline PANSS assessment during the extension. | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Loss of Effect Over Time | Placebo/Asenapine | <=Week 1 | 7 | Participants | |
| Loss of Effect Over Time | Asenapine/Asenapine | <=Week 1 | 15 | Participants | |
| Loss of Effect Over Time | Haloperidol/Haloperidol | <=Week 1 | 6 | Participants | |
| Loss of Effect Over Time | Placebo/Asenapine | >Week 1 to Week 2 | 3 | Participants | |
| Loss of Effect Over Time | Asenapine/Asenapine | >Week 1 to Week 2 | 4 | Participants | |
| Loss of Effect Over Time | Haloperidol/Haloperidol | >Week 1 to Week 2 | 4 | Participants | |
| Loss of Effect Over Time | Placebo/Asenapine | >Week 2 to Week 4 | 1 | Participants | |
| Loss of Effect Over Time | Asenapine/Asenapine | >Week 2 to Week 4 | 14 | Participants | |
| Loss of Effect Over Time | Haloperidol/Haloperidol | >Week 2 to Week 4 | 3 | Participants | |
| Loss of Effect Over Time | Placebo/Asenapine | >Week 4 to Week 8 | 3 | Participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo/Asenapine | 51 | |
| Overall Study | STARTED | Asenapine/Asenapine | 93 | |
| Overall Study | STARTED | Haloperidol/Haloperidol | 43 | |
| Overall Study | COMPLETED | Placebo/Asenapine | 20 | |
| Overall Study | COMPLETED | Asenapine/Asenapine | 30 | |
| Overall Study | COMPLETED | Haloperidol/Haloperidol | 16 | |
| Overall Study | NOT COMPLETED | Placebo/Asenapine | 31 | |
| Overall Study | NOT COMPLETED | Asenapine/Asenapine | 63 | |
| Overall Study | NOT COMPLETED | Haloperidol/Haloperidol | 27 |
Source ClinicalTrials.gov
Adverse events102
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 | Placebo/Asenapine | 4 | 50 | 5 |
| other | CONSTIPATION | Gastrointestinal disorders | Asenapine/Asenapine | 4 | 92 | 4 |
| other | CONSTIPATION | Gastrointestinal disorders | Haloperidol/Haloperidol | 3 | 43 | 3 |
| other | HYPOAESTHESIA ORAL | Gastrointestinal disorders | Placebo/Asenapine | 3 | 50 | 3 |
| other | HYPOAESTHESIA ORAL | Gastrointestinal disorders | Asenapine/Asenapine | 0 | 92 | 0 |
| other | HYPOAESTHESIA ORAL | Gastrointestinal disorders | Haloperidol/Haloperidol | 0 | 43 | 0 |
| other | NAUSEA | Gastrointestinal disorders | Placebo/Asenapine | 3 | 50 | 3 |
| other | NAUSEA | Gastrointestinal disorders | Asenapine/Asenapine | 2 | 92 | 2 |
| other | NAUSEA | Gastrointestinal disorders | Haloperidol/Haloperidol | 6 | 43 | 6 |
| other | VOMITING | Gastrointestinal disorders | Placebo/Asenapine | 2 | 50 | 2 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo/Asenapine | ||
| Total, all-cause mortality | Asenapine/Asenapine | ||
| Total, all-cause mortality | Haloperidol/Haloperidol | ||
| Total, other adverse events | Placebo/Asenapine | 28 | 50 |
| Total, other adverse events | Asenapine/Asenapine | 54 | 92 |
| Total, other adverse events | Haloperidol/Haloperidol | 25 | 43 |
| Total, serious adverse events | Placebo/Asenapine | 12 | 50 |
| Total, serious adverse events | Asenapine/Asenapine | 13 | 92 |
| Total, serious adverse events | Haloperidol/Haloperidol | 6 | 43 |
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/NCT00156065
GET https://conductscience.org/api/trials/v1/NCT00156065/results?page=2