Efficacy and Safety of Cilostazol for the Indication of CSPS

December 15, 2009 updated by: Korea Otsuka Pharmaceutical Co., Ltd.

Post Marketing Surveillance of Efficacy and Safety of Cilostazol for the Indication of CSPS

This is a multicenter, open-label, prospective study of cilostazol use for prevention of recurrence in patients with cerebral infarction.

Study Overview

Status

Completed

Conditions

Cerebral Infarction

Detailed Description

This is a multicenter, open-label, prospective study of cilostazol use to prevention of recurrence in patients with cerebral infarction.

Qualified patients will be treated with cilostazol by physician's assessment. This study will be continued for 4 years. More than 600 patients for 4 years.

Study Type

Observational

Enrollment (Actual)

650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Korea, Republic of
- - Seoul, Korea, Republic of
    - Asan Medical Center

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients in restabilization status after cerebral infarction (excluding cardiogenic cerebral embolism)

Description

Inclusion Criteria:

Patient with an experience of cerebral infarction and having a purpose for prevention of recurrence of cerebral infarction.
Age: more than 18 years of age

Exclusion Criteria:

Unqualified patients judged by study investigator(s)

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

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Cilostazol Cilostazol Treatment Patients who were in stable states after the occurrence of cerebral infarction (except cardiogenic cerebral embolism)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
1)Efficacy:Recurrence of cerebral infarction 2)Safety:Adverse Event Time Frame: 3M	3M

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Investigators

Study Director: Bo Youn Seo, Korea Otsuka Pharmaceutical Co., Ltd.

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

December 1, 2003

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria