Efficacy and Safety of Cilostazol for the Indication of CSPS | NCT00216749

Studies
Efficacy and Safety of Cilostazol for the Indication of CSPS

NCT00216749

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Dec 17, 2009Estimated

Enrollment

650Actual

Phase

Not provided

Conditions

Cerebral Infarction

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2003

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2009

Last Update Posted Date

Dec 17, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

650Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cilostazol		Cilostazol Treatment Patients who were in stable states after the occurrence of cerebral infarction (except cardiogenic cerebral embolism)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1)Efficacy:Recurrence of cerebral infarction 2)Safety:Adverse Event		3M

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bo Youn Seo	Korea Otsuka Pharmaceutical Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D002544	Cerebral Infarction

Ancestor Terms

ID	Term
D020520	Brain Infarction
D002545	Brain Ischemia
D002561	Cerebrovascular Disorders
D001927	Brain Diseases

Browse Leaves

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Browse Branches

Not provided