Early Post-Marketing Study of ELIQUIS (Apixaban) in Mexico

NCT ID: NCT02345343

Last Updated: 2017-06-28

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

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-04

Study Completion Date

2015-10-07

Brief Summary

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The primary objective of the study is to report adverse events of on-treatment AEs by the treating physicians during a specified 24-month study period in patients with venous thromboembolism at the sentinel site(s) for the National Center of Pharmacovigilance (CNFV) in Mexico.

Detailed Description

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Conditions

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Deep Vein Thrombosis Pulmonary Embolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Drug: Apixaban

Patients with VTE who are being given apixaban for the treatment and/or prevention of recurrence of DVT and PE at the sentinel site

Apixaban

Intervention Type DRUG

Interventions

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Apixaban

Intervention Type DRUG

Other Intervention Names

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Eliquis

Eligibility Criteria

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Inclusion Criteria

* Patients 18 years old with DVT and PE at the sentinel site who received at least 1 dose of apixaban for the treatment and/or prevention of recurrence of DVT and PE during the specified 24-month study period

Exclusion Criteria

* Subjects who received apixaban as part of a clinical trial
* Subjects who received apixaban for any indication other than local approved
* Contraindications included in the approved Mexican prescribing information
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Querétaro, , Mexico

Site Status

Countries

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Mexico

Related Links

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Other Identifiers

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CV185-399

Identifier Type: -

Identifier Source: org_study_id

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