A Study of the Efficacy and Safety of Vernakalant Hydrochloride (MK-6621) in Patients With Atrial Fibrillation (MK-6621-010 AM4)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cardiome Pharma
ClinicalTrials.gov Identifier:
NCT01174160
First received: July 30, 2010
Last updated: November 9, 2015
Last verified: November 2015
Results First Received: October 9, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Atrial Fibrillation
Interventions: Drug: vernakalant hydrochloride
Drug: Placebo to vernakalent hydrochloride

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Vernakalant IV

vernakalant hydrochloride

Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV

Placebo

placebo

Up to two 10-min infusions of normal saline


Participant Flow:   Overall Study
    Vernakalant IV     Placebo  
STARTED     61     62  
Discontinued Pre Dose     6     6  
Dosed     55     56  
Discontinued Post Dose     2     0  
COMPLETED     53     56  
NOT COMPLETED     8     6  
Adverse Event                 1                 0  
Lost to Follow-up                 1                 0  
Physician Decision                 1                 0  
Protocol Violation                 4                 6  
Withdrawal by Subject                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Vernakalant IV

vernakalant hydrochloride

Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV

Placebo

placebo

Up to two 10-min infusions of normal saline

Total Total of all reporting groups

Baseline Measures
    Vernakalant IV     Placebo     Total  
Number of Participants  
[units: participants]
  55     56     111  
Age  
[units: years]
Mean (Standard Deviation)
  60.7  (13.7)     59.2  (12.0)     59.9  (12.8)  
Gender  
[units: participants]
     
Female     18     26     44  
Male     37     30     67  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     1     0     1  
Not Hispanic or Latino     54     56     110  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     1     1  
Asian     55     55     110  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     0     0     0  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
Korea, Republic of     42     48     90  
India     0     1     1  
Taiwan     13     7     20  
New York Heart Association (NYHA) Classification [1]
[units: participants]
     
None (no heart failure)     50     53     103  
Class I (cardiac disease but no symptoms)     1     1     2  
Class II (mild symptoms during normal activity)     2     2     4  
Class III (Marked limitation in activity)     2     0     2  
Structural Heart Disease [2]
[units: participants]
     
None     44     43     87  
Congestive Heart Failure     5     3     8  
Ischemic Heart Disease     4     7     11  
Myocardial Infarction     1     0     1  
Valvular Heart Disease     2     3     5  
Atrial fibrillation (AF) duration  
[units: participants]
     
Less than or equal to 48 hours     33     31     64  
More than 48 hours     22     25     47  
[1] NHYA classifies the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina pain.
[2] Participants could have been classified in more than one category



  Outcome Measures

1.  Primary:   Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm   [ Time Frame: Within 90 minutes after first exposure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Jonathan Mather, Director, Head of Regulatory Affairs
Organization: Cardiome Pharma
phone: +44 (0)7581148916
e-mail: jmather@cardiome.com



Responsible Party: Cardiome Pharma
ClinicalTrials.gov Identifier: NCT01174160     History of Changes
Other Study ID Numbers: 6621-010
Study First Received: July 30, 2010
Results First Received: October 9, 2015
Last Updated: November 9, 2015
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)