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

Status

Completed

Conditions

Intervention / Treatment

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

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

Merck Sharp & Dohme LLC

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.

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