NCT01782833

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,635

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2014

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

September 21, 2018

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

2 years

First QC Date

January 31, 2013

Results QC Date

January 14, 2018

Last Update Submit

February 12, 2019

Conditions

Ischemic SymptomsCerebral Infarction

Outcome Measures

Primary Outcomes (1)

  • The Incidence Rate and the Number of AE/ADRs

    Incidence rates of overall AEs and ADRs that occurred during the study period

    Follow-up at least once from baseline to 16 weeks

Secondary Outcomes (2)

  • The Incidence Rate of Tarchycardia and Palpitation After Pletaal® SR Capsule Administration

    Follow-up at least once from baseline to 16 weeks

  • The Number and Percentage of Drop-out Patients According to Aes

    Follow-up at least once from baseline to 16 weeks

Interventions

This is Non-interventional studyOTHER

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

NHIC Ilsan Hospital

Goyang, 410-719, South Korea

Location

Inje University Seoul Pail Hospital

Seoul, 100-032, South Korea

Location

Seoul National University

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Cerebral Infarction

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Results Point of Contact

Title
Jeong, Hyo-Won
Organization
KoreaOtsukaPharma
jhw0159@otsuka.co.kr

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2013

First Posted

February 4, 2013

Study Start

January 1, 2013

Primary Completion

December 31, 2014

Study Completion

December 31, 2014

Last Updated

March 1, 2019

Results First Posted

September 21, 2018

Record last verified: 2019-02

Locations

KR(4)