Pletaal SR Post Marketing Observational Study (PLTSRPMOS)

Otsuka

Status: Completed

Conditions: Cerebral Infarction; Ischemic Symptoms

Treatments: Other: This is Non-interventional study

Study type: Observational

Funder types: Industry

Identifiers

NCT01782833

021-KOA-1201n

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,635 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design