Schizophrenia MedDRA version: 9.1 Level: LLT Classification code 10039626 Term: Schizophrenia
Conditions
Interventions
Product Name: farampator
Product Code: Org 24448
Pharmaceutical Form:
INN or Proposed INN: farampator
CAS Number: 211735-76-1
Sponsors
NV Organon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must: 1. be verified by the investigator to have participated in a previous Organon sponsored Org 24448 trial 2. sign an affirmative informed consent before evaluations are conducted; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects must not have: 1. have a concurrent acute condition that could interfere the conduct or interpretation of the evaluations. (e.g. acute psychosis, respiratory illness; current experimental medications) if possible evaluation of such subjects is deferred until resolution of such conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To provide safety follow-up evaluations to subjects who received Org 24448 • To provide a summary of cardiac status in subjects who participated in previous Organon sponsored Org 24448 trials. ;Secondary Objective: ;Primary end point(s): Cardiac status of subjects who participated in previous Organon sponsored Org 24448 trials | — |
Countries
Netherlands
Outcome results
None listed