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Study of Normal Conditions of Use, Dosing, and Safety of Intravenous (IV) Administration of Vernakalant (MK-6621-049)

NCT ID: NCT01370629

Last Updated: 2019-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2015 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2018-05-08

Brief Summary

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This non-interventional prospective study is a post-authorization safety study (PASS) of vernakalant conducted to collect information about normal conditions of use and appropriate dosing, and to quantify possible medically significant risks associated with the use of vernakalant in real-world clinical practice.

Detailed Description

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Conditions

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Atrial Fibrillation

Keywords

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atrial fibrillation cardioversion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All participants

Participants treated with vernakalant IV in acute care and inpatient hospital settings

Vernakalant

Intervention Type DRUG

Prescribed at the discretion of the physician in accordance with their usual practice

Interventions

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Vernakalant

Prescribed at the discretion of the physician in accordance with their usual practice

Intervention Type DRUG

Other Intervention Names

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BRINAVESS®

Eligibility Criteria

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Inclusion Criteria

* To be treated with intravenous vernakalant, independently of this study
* Participant and/or legal guardians willing to provide informed consent and/or informed assent according to local regulations

Exclusion Criteria

\- Enrollment in an investigational drug or device clinical trial in the 30 days prior to study enrolment. Participation in another non-interventional drug or device study or registry is permitted.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Correvio International Sarl

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medizinische Universitat Wien

Vienna, , Austria

Site Status

Aalborg, , Denmark

Site Status

Kuopio Hospital

Kuopio, , Finland

Site Status

St-Vincenz Krankenhaus

Paderborn, , Germany

Site Status

Hospital Universitario Severo Ochoa

Madrid, , Spain

Site Status

Skanes Universistetssjukhus

Malmo, , Sweden

Site Status

Countries

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United States Austria Denmark Finland Germany Spain Sweden

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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EP01029.004

Identifier Type: OTHER

Identifier Source: secondary_id

6621-049

Identifier Type: -

Identifier Source: org_study_id