Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

June 8, 2011
July 29, 2016
August 2011
December 2017   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01370629 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Study of Normal Conditions of Use, Dosing, and Safety of Intravenous (IV) Administration of Vernakalant (MK-6621-049)
A Prospective Observational Registry Study to Characterise Normal Conditions of Use, Dosing and Safety Following Administration of Vernakalant IV Sterile Concentrate
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Participants treated with intravenous vernakalant in acute care and inpatient hospital settings per usual care
Atrial Fibrillation
Drug: Vernakalant
Prescribed at the discretion of the physician in accordance with their usual practice
Other Name: BRINAVESS®
All participants
Participants treated with vernakalant IV in acute care and inpatient hospital settings
Intervention: Drug: Vernakalant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
December 2017
December 2017   (final data collection date for primary outcome measure)

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.

Both
Child, Adult, Senior
No
Contact: Steen Juul-Moller, Dr sjuul-moller@cardiome.com
Austria,   Denmark,   Germany,   Spain,   Sweden
United States
 
NCT01370629
6621-049, EP01029.004
Yes
Not Provided
Not Provided
Cardiome Pharma
Cardiome Pharma
Not Provided
Not Provided
Cardiome Pharma
July 2016

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