CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 196 enrolled
Drug / intervention
asenapine +1 moredrug
Likely dose
Asenapine 5-10 mg sublingually twice daily or olanzapine 5-20 mg orally once daily for 26 weeksAI-extracted
Key inclusion· 3
  • ✓Completed the A7501013 trial and demonstrated acceptable compliance
  • ✓Investigator assessment that patient would benefit from continued treatment
  • ✓Meet all demographic and procedural inclusion criteria from the A7501013 trial
Key exclusion· 2
  • ✕Uncontrolled or unstable clinically significant medical condition
  • ✕Documented medical noncompliance in disease management

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00174265
NCT00174265Phase 3Completed
CompareCT.gov

A Multicenter, Double-Blind, Flexible-Dose, 6-Month Extension Trial Comparing the Safety and Efficacy of Asenapine With Olanzapine in Subjects Who Completed Protocol A7501013

Organon and Co·interventional·Posted Sep 15, 2005·Updated Feb 9, 2022

In Brief

A Phase 3 clinical trial evaluating asenapine and olanzapine for Schizophrenia. Completed, enrolled 196 participants.

Detailed Summary

This is an extension study of A7501013 (P05771/NCT00145496) to further test the efficacy and safety of Asenapine compared with a marketed agent (olanzapine) in the treatment of patients with persistent negative symptoms of schizophrenia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartJul 1, 2005
Primary CompletionApr 1, 2009
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.8 years ago

Interventions

asenapinedrug

5-10 mg sublingually twice daily for 26 weeks

olanzapinedrug

5-20 mg by mouth once daily for 26 weeks