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Ranolazine in Atrial Fibrillation Following An ELectricaL CardiOversion

NCT01534962 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2014-08-19

Study results available
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Summary

Dose-ranging Phase II study testing the efficacy and safety of 3 doses of Ranolazine (low, intermediate and high, given BID) versus placebo in maintaining sinus rhythm after successful electrical cardioversion in patients with persistent atrial fibrillation (AFib).

After successful cardioversion and subsequent randomisation, patients report trans-telephonic EGCs on a daily basis to a central core ECG facility.

Maximum treatment duration is 112 days (16 weeks).

Conditions

  • Persistent Atrial Fibrillation

Interventions

DRUG

Ranolazine

Oral administration, BID; for a maximum of 112 days.

DRUG

Ranolazine

Oral administration, BID; for a maximum of 112 days.

DRUG

Ranolazine

Oral administration, BID; for a maximum of 112 days.

DRUG

Placebo

Oral administration, BID; for a maximum of 112 days.

Sponsors & Collaborators

  • Menarini Group

    lead INDUSTRY

Principal Investigators

  • Alan J Camm, Professor · Head of Clinical Cardiology; St. Gerorge's University of London, United Kingdom

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-10-31
Completion
2014-03-31

Countries

  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT01534962 on ClinicalTrials.gov