Status:

COMPLETED

6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptoms Patients Who Completed the First 6- Month Trial (A7501014)(COMPLETED)(P05772)

Lead Sponsor:

Organon and Co

Conditions:

Schizophrenia

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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 persis...

Eligibility Criteria

Inclusion

  • Continue to meet all demographic and procedural
  • inclusion criteria of the A7501013 trial to enter into
  • this extension trial.
  • Have demonstrated an acceptable degree of compliance
  • and completed the A7501013 trial, and would benefit
  • from continued treatment according to the investigator.

Exclusion

  • Have an uncontrolled, unstable clinically significant
  • medical condition.
  • Have been judged to be medically noncompliant in the
  • management of their disease.

Key Trial Info

Start Date :

July 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2009

Estimated Enrollment :

196 Patients enrolled

Trial Details

Trial ID

NCT00174265

Start Date

July 1 2005

End Date

May 1 2009

Last Update

February 9 2022

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