CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 123 enrolled
Drug / intervention
vernakalant hydrochloride +1 moredrug
Likely dose
vernakalant hydrochloride 3 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01174160
NCT01174160Phase 3Completed
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A Phase III, Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of MK-6621 in Patients With Atrial Fibrillation

Advanz Pharma·interventional·Posted Aug 3, 2010·Updated Dec 15, 2015

In Brief

A Phase 3 clinical trial evaluating vernakalant hydrochloride and Placebo to vernakalent hydrochloride for Atrial Fibrillation. Completed, enrolled 123 participants.

Detailed Summary

This study will investigate if treatment with vernakalant hydrochloride (MK-6621) results in a greater proportion of patients with treatment-induced conversion of Atrial Fibrillation to sinus rhythm compared to placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 3, 2010
Enrollment StartAug 1, 2010
Primary CompletionSep 1, 2012
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.9 years ago

Interventions

vernakalant hydrochloridedrug

Patients will receive a 3 mg/kg infusion of vernakalant hydrochloride. If the patient is in atrial fibrillation (AF) or atrial flutter (AFL) 25 minutes after the start of the infusion, then a second infusion of 2 mg/kg vernakalant hydrochloride will be administered.

Placebo to vernakalent hydrochloridedrug

Patients will receive an infusion of placebo. If the patient is in atrial fibrillation (AF) or atrial flutter (AFL) 25 minutes after the start of the infusion, then a second infusion of placebo will be administered.