Vernakalant (Oral) Prevention of Atrial Fibrillation Recurrence Post-Conversion Study

NCT00526136 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 735

Last updated 2008-12-18

No results posted yet for this study

Summary

To evaluate the safety, tolerability and efficacy of 3 doses of vernakalant (oral) (150 mg, 300 mg and 500 mg b.i.d.) administered for up to 90 days in subjects with sustained symptomatic atrial fibrillation (AF duration \> 72 hours and \< 6 months).

Conditions

Interventions

DRUG

Placebo

DRUG

Vernakalant (oral)

Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)

Sponsors & Collaborators

  • Advanz Pharma

    lead INDUSTRY

Principal Investigators

  • Gregory Beatch, PhD · Advanz Pharma

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-03-31
Completion
2008-07-31

Countries

  • Australia
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Germany
  • Hungary
  • Lithuania
  • Netherlands
  • New Zealand
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • Singapore
  • Slovakia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Ukraine

Study Locations

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Entities

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 NCT00526136 on ClinicalTrials.gov