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

This study is currently recruiting participants. (see Contacts and Locations)

Verified July 2016 by Cardiome Pharma

Sponsor:

Information provided by (Responsible Party):

Cardiome Pharma

ClinicalTrials.gov Identifier:

NCT01370629

First received: June 8, 2011

Last updated: July 29, 2016

Last verified: July 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

June 8, 2011

Last Updated Date

July 29, 2016

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

December 2017 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of participants experiencing significant hypotension [ Time Frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion ] [ Designated as safety issue: Yes ]
Number of participants experiencing significant ventricular arrhythmia [ Time Frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion ] [ Designated as safety issue: Yes ]
Number of participants experiencing significant atrial flutter [ Time Frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion ] [ Designated as safety issue: Yes ]
Number of participants experiencing significant bradycardia [ Time Frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01370629 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of participants who are converted to sinus rhythm for at least one minute [ Time Frame: Up to 90 minutes after the start (baseline) of first infusion of vernakalant ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Prospective Observational Registry Study to Characterise Normal Conditions of Use, Dosing and Safety Following Administration of Vernakalant IV Sterile Concentrate

Brief Summary

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

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Participants treated with intravenous vernakalant in acute care and inpatient hospital settings per usual care

Condition ^ICMJE

Atrial Fibrillation

Intervention ^ICMJE

Drug: Vernakalant

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

Other Name: BRINAVESS®

Study Group/Cohort (s)

All participants

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

Intervention: Drug: Vernakalant

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

2000

Estimated Completion Date

December 2017

Estimated Primary Completion Date

December 2017 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

Child, Adult, Senior

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Steen Juul-Moller, Dr

sjuul-moller@cardiome.com

Listed Location Countries ^ICMJE

Austria, Denmark, Germany, Spain, Sweden

Removed Location Countries

United States

Administrative Information

NCT Number ^ICMJE

NCT01370629

Other Study ID Numbers ^ICMJE

6621-049, EP01029.004

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Cardiome Pharma

Study Sponsor ^ICMJE

Cardiome Pharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Cardiome Pharma

Verification Date

July 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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