Pletaal SR Post Marketing Observational Study (PLT SR PMOS)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Korea Otsuka Pharmaceutical Co.,Ltd.
Sponsor:
Information provided by (Responsible Party):
Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01782833
First received: January 31, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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 Intervention
Treatment of Ischemic Symptom and Prevention of Recurrence of Cerebral Infarction
Drug: Pletaal

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: A Prospective, Post Marketing Observational Study to Evaluate the Safety of Pletaal® SR Capsule

Resource links provided by NLM:


Further study details as provided by Korea Otsuka Pharmaceutical Co.,Ltd.:

Primary Outcome Measures:
  • The incidence rate and the number of AE/ADRs [ Time Frame: Follow-up at least once from baseline to 16 weeks ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • The number and percentage of drop-out patients according to Aes [ Time Frame: Follow-up at least once from baseline to 16 weeks ] [ Designated as safety issue: Yes ]
  • The difference between AE and drug compliance according to patient's character [ Time Frame: Follow-up at least once from baseline to 16 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3000
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Detailed 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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782833

Locations
Korea, Republic of
Kyungpook National University Hospital Not yet recruiting
Daegu, Korea, Republic of
Contact: Ji Yoon Jung         
Principal Investigator: Ji Yoon Jung         
NHIC Ilsan Hospital Not yet recruiting
Kyunggido Goyangsi, Korea, Republic of, 410-719
Contact: Jun Hong Lee         
Principal Investigator: Jun Hong Lee         
Inje University Seoul Pail Hospital Not yet recruiting
Seoul, Korea, Republic of, 100-032
Contact: Jae Myeon Jung         
Principal Investigator: Jae Myeon Jung         
Seoul National University Not yet recruiting
Seoul, Korea, Republic of
Contact: Man Ho Kim         
Principal Investigator: Man Ho Kim         
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co.,Ltd.
  More Information

No publications provided

Responsible Party: Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01782833     History of Changes
Other Study ID Numbers: 021-KOA-1201n
Study First Received: January 31, 2013
Last Updated: January 31, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Infarction
Recurrence
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Disease Attributes

ClinicalTrials.gov processed this record on July 22, 2014