MedTrace Logo

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

NCT00234065 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2800

Last updated 2011-06-10

Study results available
· View outcomes & findings →

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

  • Cerebral Infarction

Interventions

DRUG

Cilostazol

oral tablet, 100 mg twice a day and placebo of aspirin once a day, 1 to 5years

DRUG

Aspirin

oral tablet, placebo of cilostazol twice a day and 81 mg once a day, 1 to 5 years

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Masahiko Abe · Division of New Product Evaluation and Development

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00234065 on ClinicalTrials.gov