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

Organon

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: asenapine; Drug: olanzapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00174265

P05772

A7501014

Aphrodite

Details and patient eligibility

About

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.

Enrollment: 196 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• Have an uncontrolled, unstable clinically significant

medical condition.

• Have been judged to be medically noncompliant in the

management of their disease.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

196 participants in 2 patient groups

asenapine

Experimental group

Treatment:

Drug: asenapine

olanzapine

Active Comparator group

Treatment:

Drug: olanzapine