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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00780585

Enrollment

Registered

2008-10-27

Start date

2007-04-30

Completion date

2009-01-31

Last updated

2014-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychosis

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.

Interventions

DRUGSCH 900460

Subjects who participated in previous trials of Org 24448 (SCH 900460)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Overall cardiac function by cardiologist evaluation including echocardiogram.	During the Evaluation Period (Visit 1 or 2 and 3 if applicable).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026