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NCT01782833: PLTSRPMOS
A Prospective, Post Marketing Observational Study to Evaluate the Safety of Pletaal® SR Capsule
trial testing This is Non-interventional study in Ischemic Symptoms in 3,635 participants. Completed in 31 December 2014.
31 December 2014
Quick facts
| Lead sponsor | Korea Otsuka Pharmaceutical Co., Ltd. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 3,635 |
| Start date | 1 January 2013 |
| Primary completion | 31 December 2014 |
| Estimated completion | 31 December 2014 |
| Sites | 4 locations across South Korea |
Drugs / interventions tested
- This is Non-interventional study
Conditions studied
- Ischemic Symptoms — all drugs for Ischemic Symptoms →
- Cerebral Infarction — all drugs for Cerebral Infarction →
Sponsor
Korea Otsuka Pharmaceutical Co., Ltd. — full company profile →
Who can join
19 and older, any sex, with Ischemic Symptoms or Cerebral Infarction. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01782833
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Korea Otsuka Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT06674291 — Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen in Korean Patients with FQ-sensitive M · not yet recruiting
- NCT05048069 — Post-Marketing Surveillance of Safety and Effectiveness of Mucosta®SR Tab. · unknown
- NCT04189705 — A Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis · Phase 3 · completed
- NCT04150146 — To Evaluate Food Effect on the Pharmacokinetics of Rebamipide in Healthy Volunteers · Phase 1 · completed
- NCT03949894 — Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domI · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01782833 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Korea Otsuka Pharmaceutical Co., Ltd.
- Last refreshed: 12 February 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01782833.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing