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

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.

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Key information

Conditions

Psychosis Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SCH 900460

Drug

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

Other names: Org 24448

Primary outcomes

Overall cardiac function by cardiologist evaluation including echocardiogram.

Time frame: During the Evaluation Period (Visit 1 or 2 and 3 if applicable).

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Oct 27, 2008
Registry last updated: Dec 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed