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Completed

NCT Number: NCT01782833

Pletaal SR Post Marketing Observational Study

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.

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Key information

Conditions

Ischemic Symptoms Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Infarction Cerebrovascular Disorders Infarction Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kyungpook National University Hospital, Daegu, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

Treatment and study plan

This is Non-interventional study

Other

Primary outcomes

  1. The Incidence Rate and the Number of AE/ADRs

    Time frame: Follow-up at least once from baseline to 16 weeks

    Incidence rates of overall AEs and ADRs that occurred during the study period

Secondary outcomes

  1. The Incidence Rate of Tarchycardia and Palpitation After Pletaal® SR Capsule Administration

    Time frame: Follow-up at least once from baseline to 16 weeks

  2. The Number and Percentage of Drop-out Patients According to Aes

    Time frame: Follow-up at least once from baseline to 16 weeks

Sponsors and collaborators

Lead sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: PLTSRPMOS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 4, 2013
Registry last updated
Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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