Clinical Trials Directory

Trials / Completed

CompletedNCT00234065

Post-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)

Post-marketing Study of Cilostazol: Study to Confirm Efficacy in Preventing Recurrent Cerebral Infarction in Comparison With Aspirin

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
2,800 (actual)
Sponsor
Otsuka Pharmaceutical Co., Ltd. · Industry
Sex
All
Age
20 Years – 80 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to investigate the efficacy of cilostazol in preventing recurrence of cerebral infarction and the safety of long-term administration of the drug (100 mg, twice daily) in patients with cerebral infarction (excluding cardiogenic cerebral embolism) in a multi-center, double-blind, parallel-group comparison with aspirin (81 mg, once daily).

Conditions

Interventions

TypeNameDescription
DRUGCilostazoloral tablet, 100 mg twice a day and placebo of aspirin once a day, 1 to 5years
DRUGAspirinoral tablet, placebo of cilostazol twice a day and 81 mg once a day, 1 to 5 years

Timeline

Start date
2003-12-01
Primary completion
2008-12-01
Completion
2008-12-01
First posted
2005-10-06
Last updated
2011-06-10
Results posted
2011-05-13

Locations

1 site across 1 country: Japan

Source: ClinicalTrials.gov record NCT00234065. Inclusion in this directory is not an endorsement.