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

Last updated: January 15, 2015
Sponsor: Solvay Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Arrhythmia

Dysrhythmia

Chest Pain

Treatment

N/A

Clinical Study ID

NCT00126074
S219.3.118
2004-000346-21
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Willing to sign informed consent before screening examinations are performed andbefore the study drug is administered

  • Females > 18 years of age

  • Subjects with documented (60 second rhythm strip) symptomatic atrial fibrillation orflutter (duration > 3 hours and < 45 days) at the time of randomization

  • Subjects who are in no distress and hemodynamically stable (supine systolic bloodpressure > 90 mmHg and diastolic blood pressure < 105 mmHg)

Exclusion

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 Design

Study Start date:
October 01, 2004
Estimated Completion Date:
March 31, 2006

Connect with a study center

  • Site 5

    Pleven,
    Bulgaria

    Site Not Available

  • Site 2

    Sofia,
    Bulgaria

    Site Not Available

  • Site 3

    Sofia,
    Bulgaria

    Site Not Available

  • Site 4

    Sofia,
    Bulgaria

    Site Not Available

  • Site 6

    Sofia,
    Bulgaria

    Site Not Available

  • Site 7

    Sofia,
    Bulgaria

    Site Not Available

  • Site 8

    Mannheim,
    Germany

    Site Not Available

  • Site 11

    Budapest,
    Hungary

    Site Not Available

  • Site 12

    Budapest,
    Hungary

    Site Not Available

  • Site 14

    Budapest,
    Hungary

    Site Not Available

  • Site 15

    Budapest,
    Hungary

    Site Not Available

  • Site 9

    Budapest,
    Hungary

    Site Not Available

  • Site 13

    Kecskemet,
    Hungary

    Site Not Available

  • Site 10

    Korhaz,
    Hungary

    Site Not Available

  • Site 16

    Piacenza,
    Italy

    Site Not Available

  • Site 22

    Chrzanow,
    Poland

    Site Not Available

  • Site 20

    Gdansk,
    Poland

    Site Not Available

  • Site 25

    Gdynia,
    Poland

    Site Not Available

  • Site 19

    Katowice,
    Poland

    Site Not Available

  • Site 18

    Krakow,
    Poland

    Site Not Available

  • Site 24

    Szczecin,
    Poland

    Site Not Available

  • Site 17

    Tarnow,
    Poland

    Site Not Available

  • Site 23

    Walbrzych,
    Poland

    Site Not Available

  • Site 21

    Zakopane,
    Poland

    Site Not Available

  • Site 26

    Honolulu, Hawaii
    United States

    Site Not Available

  • Site 27

    Tullahoma, Tennessee
    United States

    Site Not Available

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