NCT00780585

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

December 19, 2014

Status Verified

December 1, 2014

Enrollment Period

1.8 years

First QC Date

October 23, 2008

Last Update Submit

December 18, 2014

Conditions

Psychosis

Outcome Measures

Primary Outcomes (1)

  • Overall cardiac function by cardiologist evaluation including echocardiogram.

    During the Evaluation Period (Visit 1 or 2 and 3 if applicable).

Study Arms (1)

1

Subjects who participated in previous Org 24448 trials

Drug: SCH 900460

Interventions

SCH 900460DRUG

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

Also known as: Org 24448
1

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be selected from subjects who participated in previous Org 24448 trials

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychotic Disorders

Interventions

1-(benzofurazan-5-ylcarbonyl)piperidine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2008

First Posted

October 27, 2008

Study Start

April 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

December 19, 2014

Record last verified: 2014-12