A Follow up Safety Study of Patients Who Participated in Previous Studies of the Drug Org 24448 (Study P05719)(COMPLETED)
Completed
- Conditions
- Psychosis
- Interventions
- Drug: SCH 900460
- Registration Number
- NCT00780585
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This is a safety study evaluating the subjects who participated in previous Organon trials of the drug Org 24448. Patients will undergo a Screening visit, 1 or 2 Evaluation visits, and a possible Follow-Up period. During the visits, study tests, including echocardiograms, will be performed to summarize cardiac functioning.
- Detailed Description
All subjects who participated in previous Org 24448 trials and who do not meet any of the exclusion criteria are eligible.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
Inclusion Criteria
Subjects must:
- be verified by the investigator to have participated in a previous Organon sponsored Org 24448 trial.
- sign an affirmative informed consent before evaluations are conducted;
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Exclusion Criteria
Subjects must not have:
- a concurrent acute condition that could interfere with 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.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 SCH 900460 Subjects who participated in previous Org 24448 trials
- Primary Outcome Measures
Name Time Method Overall cardiac function by cardiologist evaluation including echocardiogram. During the Evaluation Period (Visit 1 or 2 and 3 if applicable).
- Secondary Outcome Measures
Name Time Method