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

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00126074
First received: August 1, 2005
Last updated: March 24, 2006
Last verified: March 2006
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Atrial Flutter
Drug: Tedisamil sesquifumarate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Study Start Date: October 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126074

Locations
United States, Hawaii
Site 26
Honolulu, Hawaii, United States
United States, Tennessee
Site 27
Tullahoma, Tennessee, United States
Bulgaria
Site 5
Pleven, Bulgaria
Site 2
Sofia, Bulgaria
Site 4
Sofia, Bulgaria
Site 6
Sofia, Bulgaria
Site 3
Sofia, Bulgaria
Site 7
Sofia, Bulgaria
Germany
Site 8
Mannheim, Germany
Hungary
Site 9
Budapest, Hungary
Site 15
Budapest, Hungary
Site 14
Budapest, Hungary
Site 12
Budapest, Hungary
Site 11
Budapest, Hungary
Site 13
Kecskemet, Hungary
Site 10
Korhaz, Hungary
Italy
Site 16
Piacenza, Italy
Poland
Site 22
Chrzanow, Poland
Site 20
Gdansk, Poland
Site 25
Gdynia, Poland
Site 19
Katowice, Poland
Site 18
Krakow, Poland
Site 24
Szczecin, Poland
Site 17
Tarnow, Poland
Site 23
Walbrzych, Poland
Site 21
Zakopane, Poland
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00126074     History of Changes
Other Study ID Numbers: S219.3.118, 2004-000346-21
Study First Received: August 1, 2005
Last Updated: March 24, 2006
Health Authority: Bulgaria: Bulgarian Drug Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Poland: Ministry of Health
Spain: Spanish Agency of Medicines
United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:
Atrial fibrillation, atrial flutter, anti-arrhythmic agents, conversion to normal sinus rhythm

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Tedisamil
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014