N/A
Completed N=3,635
Pletaal SR Post Marketing Observational Study
Ischemic Symptoms · cerebral infarction
Source: ClinicalTrials.gov NCT01782833 ↗
Enrolled (actual)
3,635
Serious AEs
2.2%
Results posted
Sep 2018
Primary outcomePrimary: The Incidence Rate and the Number of AE/ADRs — 446; 155 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Incidence Rate and the Number of AE/ADRs |
446; 155 | — |
| SECONDARY The Incidence Rate of Tarchycardia and Palpitation After Pletaal® SR Capsule Administration |
5; 19 | — |
| SECONDARY The Number and Percentage of Drop-out Patients According to Aes |
147 | — |
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.
- 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.
Data sourced from ClinicalTrials.gov (NCT01782833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.