A Prospective, Post Marketing Observational Study to Evaluate the Safety of Pletaal® SR Capsule
Conditions: Ischemic Symptoms, Cerebral Infarction
Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

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Protocol Synopsis  
Name of Sponsor:  Korea Otsuka Pharmaceutical Co., Ltd. 
Name of Investigational Medicinal Product: Cilostazol 
(Pletaal® SR cap.) 
Protocol# 
 021-KOA-1201n 
Protocol Title: 
A Prospective, Post Marketing Observational Study to evaluate 
the safety of Pletaal® SR capsule 
Clinical Phase: 
Post Marketing Observational Study 
Treatment Indication:  1. Treatment of ischemic symptoms including ulceration, pain 
and coldness in chronic arterial occlusion (Berger’s disease, 
arteriosclerosis obliterans, diabetic peripheral angiopathy). 
2. Prevention of recurrence of cerebral infarction (excluding 
cardiogenic cerebral embolism). 
Objective(s): 
Pletaal® SR capsule(q.d.) is developed and approved as 
improving Pletaal® Tablet(b.i.d.). But there is no safety data of 
Pletaal® SR capsule. The objective of this study is to evaluate 
following items in relation with use of Pletaal® SR capsule in 
general medical practice; 
1. Serious adverse event and adverse drug reaction 
profile 
2. Unexpected adverse event/adverse drug reaction 
profile 
3. Known adverse drug reaction profile 
4. Adverse event of product abuse/misuse, drug 
interactions or overdose 
5. Other information related to the product safety 
The hypothesis of this study is that Pletaal® SR capsule is safe 
in the treatment. 

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Trial Design & 
Method: 
This is a Post Marketing Observational Study of cilostazol 
(Pletaal® SR capsule). This study will be conducted in a 
prospective, single-arm, multi-center format. As this study is 
observational in nature to collect the safety data after 
administrating the Pletaal SR capsule, from baseline to 16 
weeks. 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.  
Trial Population: 
At least 3000 patients will be enrolled for this study to collect 
the safety data among various groups. Investigators across the 
country will be participating in this study and the number of 
patients to be enrolled by each investigator will vary. 

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Inclusion/Exclusion 
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. 
Investigational 
Medicinal Product(s), 
Dose, Dosage 
regimen, Treatment 
period, Formulation, 
Mode of 
Administration: 
The usual adult dose of Pletaal® SR capsule is 200mg of 
cilostazol, once daily, by the oral route. This is taken in the 
fasting state, avoid eating. 

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Safety Measure: 
1. The incidence rate and the number of AE/ADRs  
2. The incidence rate of Tarchycardia and Palpitation after 
Pletaal® SR capsule administration 
3. The number and percentage of drop-out patients according 
to AEs 
4. The difference between AE and drug compliance according 
to patient’s character 

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Statistical Methods: 
1. Demographic Information & Baseline Characteristics 
Data for the baseline characteristics is demonstrated by 
descriptive statistics. Mean, standard deviation(SD), minimum 
value, median, maximum value for continuous variables and 
frequency(n), percentage(%) for categorical variables will be 
presented in overall patients. 
2. Safety Analysis 
- The incidence rate and the number of AE/ADRs  
- The incidence rate of Tachycardia and Palpitation after 
Pletaal® SR capsule administration 
- The number and percentage of drop-out patients according to 
AEs 
- The difference between AE and drug compliance according 
to patient’s character 
All adverse events (AEs) observed during/after the 
administration will be analyzed as safety assessment. The 
number of patients and the number of AE/ADR, SAE/Serious 
ADR (SADR), unexpected AE/ADR will be calculated 
(frequency and percentage). In the final report, the incidence 
rate of all AEs during the study period will be estimated with 
its 95% confidence interval. 
The number and percentage of drop-out patients according to 
AEs and the incidence rate of AEs for the severity will be 
estimated. Safety measures will be summarized and analyzed 
to find the risk factors in overall patients by background 
factors (baseline characteristic, drug administration, 
concomitant drug treatment etc.). The analysis will be 
performed using Chi-square test or Fisher’s exact test. 
The number and percentage of AEs/ADRs will be summarized 
for special population (elderly patients, patients with liver or 
renal disease). 
Record the term of adverse event according to the System 
Organ Class, Preferred Term, Lower-Level Terms in the 
Medical Dictionary for Regulatory Activities (MedDRA). If 
there is no preferred term, look up the WHO Adverse 
Reactions Terminology (WHOART). 

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Estimated Duration 
of study 
Planned study schedule is as below; 
1. Study duration:  Jan 2013 – Dec 2014 
2. Submit the final reports to KFDA: within 1 year of 
study completion 
3. Submit the CSR to global within one year after LPLV 
or end of data collection as defined in protocol or 
contract