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Trial to Assess the Safety of Vorapaxar in Japanese Subjects With Cerebral Infarction (P05005; MK-5348-017)

NCT00684515 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2018-09-21

Study results available
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Summary

The study is designed to assess safety of Vorapaxar when added to standard of care (aspirin) in Japanese subjects with cerebral infarction. The study will assess incidence and tolerability of bleeding, major adverse cardiac events, all adverse events, and effect on expression of markers of inflammation.

Conditions

  • Cerebral Infarction

Interventions

DRUG

Vorapaxar 2.5 mg

Oral tablets; once daily for 60 days.

DRUG

Vorapaxar 1 mg

Oral tablets; once daily for 60 days

DRUG

Placebo

oral tablets; once daily for 60 days

DRUG

Aspirin 75-150 mg

oral tablets; once daily for 60 days

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-21
Primary Completion
2007-11-08
Completion
2007-11-08

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Entities

Drugs
Companies

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 NCT00684515 on ClinicalTrials.gov