Clinical trial NCT01782833: Pletaal SR Post Marketing Observational Study
Official title: A Prospective, Post Marketing Observational Study to Evaluate the Safety of Pletaal® SR Capsule
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Symptoms
Cerebral Infarction
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-02-04
Enrollment: 3635
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patient who has below 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).)

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.

Eligibility 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.

Primary outcomes:
measure: The Incidence Rate and the Number of AE/ADRs
timeFrame: Follow-up at least once from baseline to 16 weeks
Secondary outcomes:
measure: The Incidence Rate of Tarchycardia and Palpitation After Pletaal® SR Capsule Administration
timeFrame: Follow-up at least once from baseline to 16 weeks
measure: The Number and Percentage of Drop-out Patients According to Aes
timeFrame: Follow-up at least once from baseline to 16 weeks
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Goyang
country: Korea, Republic of
facility: NHIC Ilsan Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University Seoul Pail Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University
Study officials:
References: