Pletaal SR Post Marketing Observational Study

NCT ID: NCT01782833

Last Updated: 2019-03-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3635 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-12-31

Brief Summary

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This is a Post Marketing Observational Study of cilostazol (Pletaal® SR capsule). As this study is observational in nature to collect the safety data after administrating the Pletaal SR capsule, from baseline to 16 weeks.

Detailed Description

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This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the patient's follow-up is not prescriptive in nature and must be left up to the judgment of the physician (investigator), within the period of observation set forth in the protocol.

Conditions

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Ischemic Symptoms Cerebral Infarction

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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This is Non-interventional study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:

\- Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study : 1. Patients who are prescribed Pletaal® SR capsule treatment as per investigator's medical judgment for adults aged 19 and over.

2\. Patients who gave written authorization to use their personal and health data Physician (Investigator) will refer to the product market authorization (package insert) for inclusion criteria.

Exclusion Criteria:

* Patients presenting with any of the following will not be included in the study 1. Patients with hemorrhage 2. Patients with congestive heart failure 3. Patients with known hypersensitivity to Cilostazole or any ingredients of Pletaal® 4. Women who are pregnant or may possibly become pregnant 5. Patients who is not eligible to participate this study as investigator's medical judgment Physician (Investigator) will refer to the product market authorization (package insert) for exclusion criteria.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kyungpook National University Hospital

Daegu, , South Korea

Site Status

NHIC Ilsan Hospital

Goyang, , South Korea

Site Status

Inje University Seoul Pail Hospital

Seoul, , South Korea

Site Status

Seoul National University

Seoul, , South Korea

Site Status

Countries

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South Korea

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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021-KOA-1201n

Identifier Type: -

Identifier Source: org_study_id

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