Efficacy and Safety of Cilostazol for the Indication of CSPS

Cerebral Infarction Clinical Trial

Official title:

Post Marketing Surveillance of Efficacy and Safety of Cilostazol for the Indication of CSPS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00216749
• Other study ID #: Korea Pletaal CSPS PMS
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: December 15, 2009
• Start date: December 2003
• Est. completion date: October 2007

Study information

• Verified date: December 2009
• Source: Korea Otsuka Pharmaceutical Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1)Efficacy:Recurrence of cerebral infarction 2)Safety:Adverse Event		3M	Yes