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A Follow up Safety Study of Patients Who Participated in Previous Studies of the Drug Org 24448 (Study P05719)(COMPLETED)

NCT ID: NCT00780585

Last Updated: 2014-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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All subjects who participated in previous Org 24448 trials and who do not meet any of the exclusion criteria are eligible.

Conditions

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Psychosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Subjects who participated in previous Org 24448 trials

SCH 900460

Intervention Type DRUG

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

Interventions

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SCH 900460

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

Intervention Type DRUG

Other Intervention Names

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Org 24448

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2007-001611-32;

Identifier Type: -

Identifier Source: secondary_id

153006

Identifier Type: -

Identifier Source: secondary_id

P05719

Identifier Type: -

Identifier Source: org_study_id