Pletaal SR Post Marketing Observational Study (PLTSRPMOS)
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| ClinicalTrials.gov Identifier: NCT01782833 |
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Recruitment Status :
Completed
First Posted : February 4, 2013
Results First Posted : September 21, 2018
Last Update Posted : March 1, 2019
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Sponsor:
Korea Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Korea Otsuka Pharmaceutical Co., Ltd.
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Ischemic Symptoms Cerebral Infarction | Other: This is Non-interventional 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.
| Study Type : | Observational |
| Actual Enrollment : | 3635 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | A Prospective, Post Marketing Observational Study to Evaluate the Safety of Pletaal® SR Capsule |
| Study Start Date : | January 2013 |
| Actual Primary Completion Date : | December 31, 2014 |
| Actual Study Completion Date : | December 31, 2014 |
Primary Outcome Measures :
- 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 Outcome Measures :
- The Incidence Rate of Tarchycardia and Palpitation After Pletaal® SR Capsule Administration [ Time Frame: Follow-up at least once from baseline to 16 weeks ]
- The Number and Percentage of Drop-out Patients According to Aes [ Time Frame: Follow-up at least once from baseline to 16 weeks ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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).)
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01782833
Locations
| Korea, Republic of | |
| Kyungpook National University Hospital | |
| Daegu, Korea, Republic of, 700-721 | |
| NHIC Ilsan Hospital | |
| Goyang, Korea, Republic of, 410-719 | |
| Inje University Seoul Pail Hospital | |
| Seoul, Korea, Republic of, 100-032 | |
| Seoul National University | |
| Seoul, Korea, Republic of, 110-744 | |
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.
Study Documents (Full-Text)
| Responsible Party: | Korea Otsuka Pharmaceutical Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01782833 |
| Other Study ID Numbers: |
021-KOA-1201n |
| First Posted: | February 4, 2013 Key Record Dates |
| Results First Posted: | September 21, 2018 |
| Last Update Posted: | March 1, 2019 |
| Last Verified: | February 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Additional relevant MeSH terms:
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Cerebral Infarction Infarction Ischemia Pathologic Processes Necrosis Brain Infarction Brain Ischemia |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Stroke Vascular Diseases Cardiovascular Diseases |