CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 306 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
  • ✓Must have completed the Protocol 25543 (NCT 00212836) parent trial
  • ✓Must continue to meet all demographic and procedural inclusion criteria from the parent Protocol 25543 trial
  • ✓Investigator must determine patient would benefit from continued treatment
Key exclusion· 2
  • ✕Uncontrolled or unstable clinically significant medical condition
  • ✕History of medical noncompliance in disease management

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

Search/NCT00265343
NCT00265343Phase 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 the Protocol 25543 (NCT 00212836; P05817)

Organon and Co·interventional·Posted Dec 14, 2005·Updated Feb 9, 2022

In Brief

A Phase 3 clinical trial evaluating asenapine and olanzapine for Schizophrenia. Completed, enrolled 306 participants.

Detailed Summary

This is an extension study 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
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 14, 2005
Enrollment StartDec 1, 2005
Primary CompletionDec 1, 2007
Study CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 20.6 years ago

Interventions

asenapinedrug

5-10 mg sublingually twice daily for 26 weeks

olanzapinedrug

5-20 mg by mouth once daily for 26 weeks