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Pletaal SR Post Marketing Observational Study (PLT SR PMOS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Korea Otsuka Pharmaceutical Co., Ltd..
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01782833
First Posted: February 4, 2013
Last Update Posted: February 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Korea Otsuka Pharmaceutical Co., Ltd.
  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

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 ]

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 ]
  • The difference between AE and drug compliance according to patient's character [ Time Frame: Follow-up at least once from baseline to 16 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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 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

Responsible Party: Korea Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01782833     History of Changes
Other Study ID Numbers: 021-KOA-1201n
First Submitted: January 31, 2013
First Posted: February 4, 2013
Last Update Posted: February 4, 2013
Last Verified: January 2013

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