Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Female Subjects

January 15, 2015 updated by: Solvay Pharmaceuticals

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety of Intravenous Tedisamil Sesquifumarate in the Rapid Conversion to Normal Sinus Rhythm in Female Subjects With Recent Onset Atrial Fibrillation or Flutter

The purpose of this study is to demonstrate the ability of tedisamil to convert atrial fibrillation or flutter into normal sinus rhythm (NSR) in female patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria
        • Site 5
      • Sofia, Bulgaria
        • Site 2
      • Sofia, Bulgaria
        • Site 3
      • Sofia, Bulgaria
        • Site 4
      • Sofia, Bulgaria
        • Site 6
      • Sofia, Bulgaria
        • Site 7
  • Germany
      • Mannheim, Germany
        • Site 8
  • Hungary
      • Budapest, Hungary
        • Site 11
      • Budapest, Hungary
        • Site 12
      • Budapest, Hungary
        • Site 14
      • Budapest, Hungary
        • Site 15
      • Budapest, Hungary
        • Site 9
      • Kecskemet, Hungary
        • Site 13
      • Korhaz, Hungary
        • Site 10
  • Italy
      • Piacenza, Italy
        • Site 16
  • Poland
      • Chrzanow, Poland
        • Site 22
      • Gdansk, Poland
        • Site 20
      • Gdynia, Poland
        • Site 25
      • Katowice, Poland
        • Site 19
      • Krakow, Poland
        • Site 18
      • Szczecin, Poland
        • Site 24
      • Tarnow, Poland
        • Site 17
      • Walbrzych, Poland
        • Site 23
      • Zakopane, Poland
        • Site 21
  • United States
    • Hawaii
      • Honolulu, Hawaii, United States
        • Site 26
    • Tennessee
      • Tullahoma, Tennessee, United States
        • Site 27

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Willing to sign informed consent before screening examinations are performed and before the study drug is administered
  • Females > 18 years of age
  • Subjects with documented (60 second rhythm strip) symptomatic atrial fibrillation or flutter (duration > 3 hours and < 45 days) at the time of randomization
  • Subjects who are in no distress and hemodynamically stable (supine systolic blood pressure > 90 mmHg and diastolic blood pressure < 105 mmHg)

Exclusion Criteria:

  • Pregnancy and lactation
  • Acute myocardial infarction and cerebrovascular accidents
  • Coronary syndromes and congestive heart failure (CHF) New York Heart Association (NYHA) IV
  • Life-threatening ventricular arrhythmias and electrocardiogram (ECG) abnormalities
  • Concurrent antiarrhythmic treatments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solvay Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

August 1, 2005

First Submitted That Met QC Criteria

August 1, 2005

First Posted (Estimate)

August 2, 2005

Study Record Updates

Last Update Posted (Estimate)

January 16, 2015

Last Update Submitted That Met QC Criteria

January 15, 2015

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S219.3.118
  • 2004-000346-21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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