Trial · NCT00281320
Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)
NCT00281320, Phase 3, Completed, Organon and Co; results first posted 2010-09-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717). Trials, record NCT00281320. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00281320
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)
- NCT number
- NCT00281320
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 122 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Psychosis
- Interventions
- Asenapine
- First posted
- 2006-01-24
- Last updated
- 2022-02-09
- Results first posted
- 2010-09-09
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experienced an Adverse Event | Up to Day 42 (treatment period) | Participants who experienced treatment-emergent adverse events, defined as newly reported events after baseline or events reported to have worsened in severity since baseline (from the date of informed consent to the last dose day + 7 days for non-serious adverse events and 30 days for serious adverse events). |
| Primary | Number of Participants Who Discontinued Because of an Adverse Event | up to 30 days after study medication stop date | Discontinuations due to treatment-emergent adverse events starting on or after Day1 and up to 7 days after study medication stop date (30 days for serious adverse events). |
| Primary | Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax | Day 4 or 8 | Tmax defined as time to peak concentration. |
| Primary | Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax | Day 4 or 8 | Cmax defined as peak concentration. |
| Primary | Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax | Day 4 or 8 | dn-Cmax is defined as dose normalized peak concentration. |
| Primary | Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin | Day 4 or 8 | Cmin defined as pre-dose concentration. |
| Primary | Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12 | Day 4 or 8 | AUC 0-12 defined as area-under-the-curve from zero to time point 12 hours. |
| Primary | Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12 | Day 4 or 8 | dn-AUC 0-12 defined as dose-normalized area-under-the-curve from zero to time point 12 hours. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced an Adverse Event | Up to Day 42 (treatment period) | Per protocol | Participants | NUMBER |
| PRIMARY | Number of Participants Who Discontinued Because of an Adverse Event | up to 30 days after study medication stop date | Per protocol | participants | NUMBER |
| PRIMARY | Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax | Day 4 or 8 | All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics. | hours | MEDIAN |
| PRIMARY | Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax | Day 4 or 8 | All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics. | ng/mL | MEAN |
| PRIMARY | Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax | Day 4 or 8 | All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics. | ng/mL/mg | MEAN |
| PRIMARY | Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin | Day 4 or 8 | All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics. | ng/mL | MEAN |
| PRIMARY | Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12 | Day 4 or 8 | All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics. | ng*h/mL | MEAN |
| PRIMARY | Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12 | Day 4 or 8 | All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics. | ng*h/mL/mg | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced an Adverse Event | Asenapine 2-10 mg Twice Daily (BID) | 44 | Participants | ||
| Number of Participants Who Experienced an Adverse Event | Asenapine 5-10 mg BID | 44 | Participants | ||
| Number of Participants Who Discontinued Because of an Adverse Event | Asenapine 2-10 mg Twice Daily (BID) | 12 | participants | ||
| Number of Participants Who Discontinued Because of an Adverse Event | Asenapine 5-10 mg BID | 9 | participants | ||
| Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax | Asenapine 5mg BID Day 4 | 1.00 | Full Range 0.417 to 4.23 | hours | |
| Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax | Asenapine 10mg BID Day 8 | 1.06 | Full Range 0.417 to 4.08 | hours | |
| Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax | Asenapine 5mg BID Day 4 | 6.01 | Standard Deviation 3.89 | ng/mL | |
| Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax | Asenapine 10mg BID Day 8 | 10.3 | Standard Deviation 6.71 | ng/mL | |
| Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax | Asenapine 5mg BID Day 4 | 1.20 | Standard Deviation 0.778 | ng/mL/mg | |
| Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax | Asenapine 10mg BID Day 8 | 1.03 | Standard Deviation 0.671 | ng/mL/mg |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Asenapine 2-10 mg Twice Daily (BID) | 61 | |
| Overall Study | STARTED | Asenapine 5-10 mg BID | 61 | |
| Overall Study | COMPLETED | Asenapine 2-10 mg Twice Daily (BID) | 36 | |
| Overall Study | COMPLETED | Asenapine 5-10 mg BID | 40 | |
| Overall Study | NOT COMPLETED | Asenapine 2-10 mg Twice Daily (BID) | 25 | |
| Overall Study | NOT COMPLETED | Asenapine 5-10 mg BID | 21 |
Source ClinicalTrials.gov
Adverse events40
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 | Asthenia | General disorders | Asenapine 2-10mg BID | 4 | 61 | 4 |
| other | Asthenia | General disorders | Asenapine 5-10mg BID | 2 | 61 | 2 |
| other | Urinary tract infection | Infections and infestations | Asenapine 2-10mg BID | 4 | 61 | 4 |
| other | Urinary tract infection | Infections and infestations | Asenapine 5-10mg BID | 0 | 61 | 0 |
| other | Blood pressure increased | Investigations | Asenapine 2-10mg BID | 0 | 61 | 0 |
| other | Blood pressure increased | Investigations | Asenapine 5-10mg BID | 5 | 61 | 7 |
| other | Dizziness | Nervous system disorders | Asenapine 2-10mg BID | 4 | 61 | 4 |
| other | Dizziness | Nervous system disorders | Asenapine 5-10mg BID | 2 | 61 | 3 |
| other | Headache | Nervous system disorders | Asenapine 2-10mg BID | 4 | 61 | 4 |
| other | Headache | Nervous system disorders | Asenapine 5-10mg BID | 4 | 61 | 4 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Asenapine 2-10mg BID | ||
| Total, all-cause mortality | Asenapine 5-10mg BID | ||
| Total, other adverse events | Asenapine 2-10mg BID | 21 | 61 |
| Total, other adverse events | Asenapine 5-10mg BID | 21 | 61 |
| Total, serious adverse events | Asenapine 2-10mg BID | 6 | 61 |
| Total, serious adverse events | Asenapine 5-10mg BID | 3 | 61 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21755540 | RESULT |
Source PubMed
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Asenapine 2-10 mg Twice Daily (BID) vs Asenapine 5-10 mg BID: Number of Participants Who Discontinued Because of an Adverse Event | Trial comparisons |
| Asenapine 2-10 mg Twice Daily (BID) vs Asenapine 5-10 mg BID: Number of Participants Who Experienced an Adverse Event | Trial comparisons |
| Asenapine 2-10mg BID vs Asenapine 5-10mg BID: 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/NCT00281320
GET https://conductscience.org/api/trials/v1/NCT00281320/events?page=2