Pletaal SR Post Marketing Observational Study

Completed

• Conditions: Ischemic Symptoms; Cerebral Infarction

• Registration Number: NCT01782833
• Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-31
• Study First Submitted QC: 2013-01-31
• Study First Posted: 2013-02-04
• Primary Completion: 2014-12-31
• Study Completion: 2014-12-31
• Results First Submitted: 2018-01-14
• Results First Submitted QC: 2018-01-14
• Results First Posted: 2018-09-21
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3635

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Incidence Rate and the Number of AE/ADRs	Follow-up at least once from baseline to 16 weeks	Incidence rates of overall AEs and ADRs that occurred during the study period

Secondary Outcome Measures

Name	Time	Method
The Incidence Rate of Tarchycardia and Palpitation After Pletaal® SR Capsule Administration	Follow-up at least once from baseline to 16 weeks
The Number and Percentage of Drop-out Patients According to Aes	Follow-up at least once from baseline to 16 weeks

Trial Locations

Locations (4)

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of

Inje University Seoul Pail Hospital; 🇰🇷 Seoul, Korea, Republic of

NHIC Ilsan Hospital; 🇰🇷 Goyang, Korea, Republic of

Seoul National University; 🇰🇷 Seoul, Korea, Republic of