A Follow up Safety Study of Patients Who Participated in Previous Studies of the Drug Org 24448 (Study P05719)(COMPLETED)
December 18, 2014 updated by: Merck Sharp & Dohme LLC
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
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.
Study Overview
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
Enrollment (Actual)
95
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects will be selected from subjects who participated in previous Org 24448 trials
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
Subjects who participated in previous Org 24448 trials
|
Subjects who participated in previous trials of Org 24448 (SCH 900460)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall cardiac function by cardiologist evaluation including echocardiogram.
Time Frame: During the Evaluation Period (Visit 1 or 2 and 3 if applicable).
|
During the Evaluation Period (Visit 1 or 2 and 3 if applicable).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
October 23, 2008
First Submitted That Met QC Criteria
October 24, 2008
First Posted (Estimate)
October 27, 2008
Study Record Updates
Last Update Posted (Estimate)
December 19, 2014
Last Update Submitted That Met QC Criteria
December 18, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P05719
- 2007-001611-32;
- 153006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.