Post Marketing Surveillance to Monitor the Safety and Efficacy of Metalyse® in Korean Patients With Acute Myocardial Infarction

NCT ID: NCT02206646

Last Updated: 2014-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

987 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-02-28

Brief Summary

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To monitor the safety of Metalyse® in clinical practice in patients with acute myocardial infarction over a period of 6 years as required by Korean authorities, with the following observations:

1. Unexpected adverse drug reactions
2. Frequency and nature of adverse events (AEs)
3. Factors on the safety and efficacy profile of the Metalyse® Injection. Efficacy of Metalyse® was also assessed.

Detailed Description

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Conditions

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Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Metalyse

weight-adjusted dose

Metalyse

Intervention Type DRUG

Interventions

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Metalyse

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* none

Exclusion Criteria

* none
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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1123.25

Identifier Type: -

Identifier Source: org_study_id

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