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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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: October 23, 2008
Last updated: December 18, 2014
Last verified: December 2014
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
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

Further study details as provided by Merck Sharp & Dohme Corp.:

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
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.

Ages Eligible for Study:   Child, Adult, Senior
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00780585     History of Changes
Other Study ID Numbers: P05719  2007-001611-32;  153006 
Study First Received: October 23, 2008
Last Updated: December 18, 2014
Health Authority: United States: Food and Drug Administration processed this record on October 27, 2016