Pletaal SR Post Marketing Observational Study

Cerebral Infarction Clinical Trial

— PLTSRPMOS  

Official title:

A Prospective, Post Marketing Observational Study to Evaluate the Safety of Pletaal® SR Capsule

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782833
• Other study ID #: 021-KOA-1201n
• Status: Completed
• Start date: January 2013
• Est. completion date: December 31, 2014

Study information

• Verified date: February 2019
• Source: Korea Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3635
• Est. completion date: December 31, 2014
• Est. primary completion date: December 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction
• Ischemic Symptoms

Intervention

Other:
• This is Non-interventional study

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	NHIC Ilsan Hospital	Goyang
Korea, Republic of	Inje University Seoul Pail Hospital	Seoul
Korea, Republic of	Seoul National University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Incidence Rate and the Number of AE/ADRs	Incidence rates of overall AEs and ADRs that occurred during the study period	Follow-up at least once from baseline to 16 weeks
Secondary	The Incidence Rate of Tarchycardia and Palpitation After Pletaal® SR Capsule Administration		Follow-up at least once from baseline to 16 weeks
Secondary	The Number and Percentage of Drop-out Patients According to Aes		Follow-up at least once from baseline to 16 weeks