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

Psychosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00780585
• Other study ID #: P05719
• Secondary ID: 2007-001611-32;1
• Status: Completed
• Phase: N/A
• First received: October 23, 2008
• Last updated: December 18, 2014
• Start date: April 2007
• Est. completion date: January 2009

Study information

• Verified date: December 2014
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Psychosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

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