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A Phase 3b Study of Vernakalant Injection in Patients With Recent Onset Symptomatic Atrial Fibrillation (AF)(MK-6621-045)

NCT00989001 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2014-03-10

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of vernakalant injection in subjects with recent onset (AF \> 3 hours to \<= 7 days), symptomatic atrial fibrillation and no evidence or history of congestive heart failure.

Conditions

Interventions

DRUG

Vernakalant

Maximum volume of 100 mL as per the dosing schedule, administered intravenously (IV) over 10 minutes

DRUG

Placebo

Injection

Sponsors & Collaborators

  • Advanz Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-11-30
Completion
2010-11-30

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00989001 on ClinicalTrials.gov