Phase 3
N=122
Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)
Psychosis
Bottom Line
View on ClinicalTrials.gov: NCT00281320 ↗Enrolled (actual)
122
Serious AEs
7.4%
Results posted
Sep 2010
Primary outcome: Primary: Number of Participants Who Experienced an Adverse Event — 44; 44 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Asenapine (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced an Adverse Event |
44; 44 | — |
| PRIMARY Number of Participants Who Discontinued Because of an Adverse Event |
12; 9 | — |
| PRIMARY Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax |
1.00; 1.06 | — |
| PRIMARY Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax |
6.01; 10.3 | — |
| PRIMARY Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax |
1.20; 1.03 | — |
| PRIMARY Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin |
2.28; 4.06 | — |
| PRIMARY Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12 |
38.6; 70.3 | — |
| PRIMARY Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12 |
7.72; 7.03 | — |
Summary
This study evaluates the safety and tolerability of Asenapine in elderly patients with psychosis.
Eligibility Criteria
Inclusion Criteria
- Elderly subjects with psychosis
Exclusion Criteria
- Have an uncontrolled, unstable clinically significant
medical condition.
- Have an established diagnosis of dementia
Data sourced from ClinicalTrials.gov (NCT00281320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.