Efficacy and Safety of Cilostazol for the Indication of CSPS

This study has been completed.

First Received: September 14, 2005 Last Updated: December 15, 2009 History of Changes

Sponsor:	Korea Otsuka Pharmaceutical Co.,Ltd.
Information provided by:	Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:	NCT00216749

Purpose

This is a multicenter, open-label, prospective study of cilostazol use for prevention of recurrence in patients with cerebral infarction.

Condition	Phase
Cerebral Infarction	Phase IV

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Post Marketing Surveillance of Efficacy and Safety of Cilostazol for the Indication of CSPS

Resource links provided by NLM:

Drug Information available for: Cilostazol

U.S. FDA Resources

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

Primary Outcome Measures:

1)Efficacy:Recurrence of cerebral infarction 2)Safety:Adverse Event [ Time Frame: 3M ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	650
Study Start Date:	December 2003
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts
Cilostazol Cilostazol Treatment Patients who were in stable states after the occurrence of cerebral infarction (except cardiogenic cerebral embolism)

Detailed Description:

This is a multicenter, open-label, prospective study of cilostazol use to prevention of recurrence in patients with cerebral infarction.

Qualified patients will be treated with cilostazol by physician's assessment. This study will be continued for 4 years. More than 600 patients for 4 years.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients in restabilization status after cerebral infarction (excluding cardiogenic cerebral embolism)

Criteria

Inclusion Criteria:

Patient with an experience of cerebral infarction and having a purpose for prevention of recurrence of cerebral infarction.
Age: more than 18 years of age

Exclusion Criteria:

Unqualified patients judged by study investigator(s)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216749

Locations

Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of

Sponsors and Collaborators

Korea Otsuka Pharmaceutical Co.,Ltd.

Investigators

Study Director:

Bo Youn Seo

Korea Otsuka Pharmaceutical Co.,Ltd.

More Information

No publications provided

Responsible Party:	Korea Otsuka Pharmaceutical Co. Ltd ( Clinical Reserch Team Leader )
Study ID Numbers:	Korea Pletaal CSPS PMS
Study First Received:	September 14, 2005
Last Updated:	December 15, 2009
ClinicalTrials.gov Identifier:	NCT00216749 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Korea Otsuka Pharmaceutical Co.,Ltd.:

Cerebral Infarction Prevention
Cilostazol

Additional relevant MeSH terms:

Respiratory System Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Hematologic Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Brain Diseases
Neuroprotective Agents
Cerebrovascular Disorders
Necrosis
Fibrin Modulating Agents
Pathologic Processes
Therapeutic Uses
Brain Ischemia

Cardiovascular Diseases
Cilostazol
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases
Anti-Asthmatic Agents
Enzyme Inhibitors
Cardiovascular Agents
Ischemia
Protective Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Autonomic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010