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

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ClinicalTrials.gov Identifier: NCT00780585
Recruitment Status : Completed
First Posted : October 27, 2008
Last Update Posted : December 19, 2014
Sponsor:
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
1
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
Criteria

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.
ClinicalTrials.gov Identifier: NCT00780585     History of Changes
Other Study ID Numbers: P05719
2007-001611-32;
153006
First Posted: October 27, 2008    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014