A multi-center cardiac safety study of subjects who participated in Organon sponsored Phase 1 and Phase 2 completed and discontinued trials with Org 24448 (Protocols: 22601;22602;22603; 153001;153002;153003;153004, 29402; III.04.0311).
Phase 1
- Conditions
- SchizophreniaMedDRA version: 9.1 Level: LLT Classification code 10039626 Term: Schizophrenia
- Registration Number
- EUCTR2007-001611-32-NL
- Lead Sponsor
- V Organon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 295
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method