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| ID | Type | Description | Link |
|---|---|---|---|
| A7501021 |
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This study evaluates the safety and tolerability of Asenapine in elderly patients with psychosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asenapine 2-10 mg BID | Experimental | Dose titration from 2 mg to 5 mg to 10 mg twice daily (BID) |
|
| Asenapine 5-10mg BID | Experimental | Dose titration from 5 mg to 10 mg BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asenapine | Drug | Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6); or Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event | 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). | Up to Day 42 (treatment period) |
| Number of Participants Who Discontinued Because of an Adverse Event | 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). | up to 30 days after study medication stop date |
| Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax | Tmax defined as time to peak concentration. | Day 4 or 8 |
| Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax | Cmax defined as peak concentration. | Day 4 or 8 |
| Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax | dn-Cmax is defined as dose normalized peak concentration. | Day 4 or 8 |
| Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin | Cmin defined as pre-dose concentration. | Day 4 or 8 |
| Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12 |
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Inclusion Criteria:
Exclusion Criteria:
medical condition.
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21755540 | Result | Dubovsky SL, Frobose C, Phiri P, de Greef R, Panagides J. Short-term safety and pharmacokinetic profile of asenapine in older patients with psychosis. Int J Geriatr Psychiatry. 2012 May;27(5):472-82. doi: 10.1002/gps.2737. Epub 2011 Jul 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Asenapine 2-10 mg Twice Daily (BID) | Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6) |
| FG001 | Asenapine 5-10 mg BID | Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Asenapine 2-10 mg BID | Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6) |
| BG001 | Asenapine 5-10 mg BID |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced an Adverse Event | 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). | Per protocol | Posted | Number | Participants | Up to Day 42 (treatment period) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Asenapine 2-10mg BID |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardio-respiratory arrest | Cardiac disorders | 10.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | 10.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C522667 | asenapine |
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|
AUC 0-12 defined as area-under-the-curve from zero to time point 12 hours. |
| Day 4 or 8 |
| Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12 | dn-AUC 0-12 defined as dose-normalized area-under-the-curve from zero to time point 12 hours. | Day 4 or 8 |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Other |
|
Asenapine 5 mg twice daily (BID) on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6)
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Days 5 through the end of the trial (Week 6)
|
|
| Primary | Number of Participants Who Discontinued Because of an Adverse Event | 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). | Per protocol | Posted | Number | participants | up to 30 days after study medication stop date |
|
|
|
| Primary | Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax | Tmax defined as time to peak concentration. | 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. | Posted | Median | Full Range | hours | Day 4 or 8 |
|
|
|
| Primary | Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax | Cmax defined as peak concentration. | 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. | Posted | Mean | Standard Deviation | ng/mL | Day 4 or 8 |
|
|
|
| Primary | Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax | dn-Cmax is defined as dose normalized peak concentration. | 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. | Posted | Mean | Standard Deviation | ng/mL/mg | Day 4 or 8 |
|
|
|
| Primary | Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin | Cmin defined as pre-dose concentration. | 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. | Posted | Mean | Standard Deviation | ng/mL | Day 4 or 8 |
|
|
|
| Primary | Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12 | AUC 0-12 defined as area-under-the-curve from zero to time point 12 hours. | 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. | Posted | Mean | Standard Deviation | ng*h/mL | Day 4 or 8 |
|
|
|
| Primary | Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12 | dn-AUC 0-12 defined as dose-normalized area-under-the-curve from zero to time point 12 hours. | 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. | Posted | Mean | Standard Deviation | ng*h/mL/mg | Day 4 or 8 |
|
|
|
| 6 |
| 61 |
| 21 |
| 61 |
| EG001 | Asenapine 5-10mg BID | 3 | 61 | 21 | 61 |
| Ventricular extrasystoles | Cardiac disorders | 10.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | 10.1 | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | 10.1 | Systematic Assessment |
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| Metastases to pleura | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 10.1 | Systematic Assessment |
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| Extrapyramidal disorder | Nervous system disorders | 10.1 | Systematic Assessment |
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| Mania | Psychiatric disorders | 10.1 | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | 10.1 | Systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | 10.1 | Systematic Assessment |
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| Schizophrenia | Psychiatric disorders | 10.1 | Systematic Assessment |
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| Azotaemia | Renal and urinary disorders | 10.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | 10.1 | Systematic Assessment |
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| Blood pressure increased | Investigations | 10.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | 10.1 | Systematic Assessment |
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| Headache | Nervous system disorders | 10.1 | Systematic Assessment |
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| Parkinsonism | Nervous system disorders | 10.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | 10.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | 10.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | 10.1 | Systematic Assessment |
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