Phase 3 Completed N=122 Randomized Quadruple-blind Treatment

Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)

Psychosis

Source: ClinicalTrials.gov NCT00281320 ↗

Enrolled (actual)

122

Serious AEs

7.4%

Results posted

Sep 2010

Primary outcomePrimary: Number of Participants Who Experienced an Adverse Event — 44; 44 Participants

Summary

This study evaluates the safety and tolerability of Asenapine in elderly patients with psychosis.

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	—

Eligibility Criteria

Inclusion Criteria

Elderly subjects with psychosis

Exclusion Criteria

Have an uncontrolled, unstable clinically significant

medical condition.

Have an established diagnosis of dementia

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.