Study of Normal Conditions of Use, Dosing, and Safety of Intravenous (IV) Administration of Vernakalant (MK-6621-049)
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ClinicalTrials.gov Identifier: NCT01370629 |
Recruitment Status
:
Recruiting
First Posted
: June 10, 2011
Last Update Posted
: January 24, 2018
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Sponsor:
Cardiome Pharma
Information provided by (Responsible Party):
Cardiome Pharma
Tracking Information | |||||
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First Submitted Date | June 8, 2011 | ||||
First Posted Date | June 10, 2011 | ||||
Last Update Posted Date | January 24, 2018 | ||||
Study Start Date | August 2011 | ||||
Estimated Primary Completion Date | April 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | Complete list of historical versions of study NCT01370629 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures |
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 ] | ||||
Original Secondary Outcome Measures | Same as current | ||||
Current Other Outcome Measures | Not Provided | ||||
Original Other Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Study of Normal Conditions of Use, Dosing, and Safety of Intravenous (IV) Administration of Vernakalant (MK-6621-049) | ||||
Official Title | 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 | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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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 | Atrial Fibrillation | ||||
Intervention | Drug: Vernakalant
Prescribed at the discretion of the physician in accordance with their usual practice
Other Name: BRINAVESS® |
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Study Groups/Cohorts | All participants
Participants treated with vernakalant IV in acute care and inpatient hospital settings
Intervention: Drug: Vernakalant |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
2000 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | August 2018 | ||||
Estimated Primary Completion Date | April 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
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. |
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Sex/Gender |
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Ages | Child, Adult, Senior | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | Austria, Denmark, Finland, Germany, Spain, Sweden | ||||
Removed Location Countries | United States | ||||
Administrative Information | |||||
NCT Number | NCT01370629 | ||||
Other Study ID Numbers | 6621-049 EP01029.004 ( Other Identifier: Merck ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement | Not Provided | ||||
Responsible Party | Cardiome Pharma | ||||
Study Sponsor | Cardiome Pharma | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | Cardiome Pharma | ||||
Verification Date | January 2018 |