A Follow up Safety Study of Patients Who Participated in Previous Studies of the Drug Org 24448 (Study P05719)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00780585
First received: October 23, 2008
Last updated: October 21, 2009
Last verified: October 2009
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Purpose
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 | Intervention |
|---|---|
|
Psychosis |
Drug: SCH 900460 |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Schering-Plough:
Primary Outcome Measures:
- Overall cardiac function by cardiologist evaluation including echocardiogram. [ Time Frame: During the Evaluation Period (Visit 1 or 2 and 3 if applicable). ] [ Designated as safety issue: Yes ]
| Enrollment: | 95 |
| Study Start Date: | April 2007 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
All subjects who participated in previous Org 24448 trials and who do not meet any of the exclusion criteria are eligible.
Eligibility| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00780585 History of Changes |
| Other Study ID Numbers: | P05719, 2007-001611-32;, 153006 |
| Study First Received: | October 23, 2008 |
| Last Updated: | October 21, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
ClinicalTrials.gov processed this record on May 23, 2013