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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00780585
Recruitment Status : Completed
First Posted : October 27, 2008
Last Update Posted : December 19, 2014
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment
Psychosis Drug: SCH 900460

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

Study Type : Observational
Actual Enrollment : 95 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Study Start Date : April 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Group/Cohort Intervention/treatment
Subjects who participated in previous Org 24448 trials
Drug: SCH 900460
Subjects who participated in previous trials of Org 24448 (SCH 900460)
Other Name: Org 24448

Primary Outcome Measures :
  1. Overall cardiac function by cardiologist evaluation including echocardiogram. [ Time Frame: During the Evaluation Period (Visit 1 or 2 and 3 if applicable). ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be selected from subjects who participated in previous Org 24448 trials

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.

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00780585     History of Changes
Other Study ID Numbers: P05719
First Posted: October 27, 2008    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014