A Follow up Safety Study of Patients Who Participated in Previous Studies of the Drug Org 24448 (Study P05719)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Psychosis

Treatments: Drug: SCH 900460

Study type: Observational

Funder types: Industry

Identifiers

NCT00780585

153006

P05719

2007-001611-32 ;

Details and patient eligibility

About

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.

Full description

All subjects who participated in previous Org 24448 trials and who do not meet any of the exclusion criteria are eligible.

Enrollment: 95 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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;

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.

Trial design

95 participants in 1 patient group

1

Description:

Subjects who participated in previous Org 24448 trials

Treatment:

Drug: SCH 900460