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

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00126061
First received: August 1, 2005
Last updated: March 9, 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 male 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 Male 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:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing to sign informed consent before screening examinations are performed and before the study drug is administered
  • Males > 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:

  • Acute myocardial infarction and cerebrovascular accidents
  • Coronary and heart failure symptoms
  • Life-threatening ventricular arrhythmias and electrocardiogram (ECG) abnormalities
  • Electrolyte 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: NCT00126061

Locations
United States, California
Site 26
Los Angeles, California, United States
Site 27
Santa Ana, California, United States
United States, Hawaii
Site 24
Honolulu, Hawaii, United States
United States, Tennessee
Site 25
Tullahoma, Tennessee, United States
Czech Republic
Site 5
Brno, Czech Republic
Site 4
Plzen, Czech Republic
Site 2
Prague, Czech Republic
Site 3
Prague, Czech Republic
Site 6
Prague, Czech Republic
Poland
Site 8
Bydgoszcz, Poland
Site 11
Lodz, Poland
Site 10
Lublin, Poland
Site 12
Medyczna, Poland
Site 9
Warszawa, Poland
Site 7
Warszawa, Poland
Russian Federation
Site 17
Moscow, Russian Federation
Site 13
Moscow, Russian Federation
Site 14
Moscow, Russian Federation
Site 15
Moscow, Russian Federation
Site 16
Moscow, Russian Federation
Ukraine
Site 20
Dnepropetrovsk, Ukraine
Site 18
Kiev, Ukraine
Site 21
Kiev, Ukraine
Site 19
Lviv, Ukraine
Site 23
Odessa, Ukraine
Site 22
Zaporozhye, Ukraine
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00126061     History of Changes
Other Study ID Numbers: S219.3.117, 2004-000458-22
Study First Received: August 1, 2005
Last Updated: March 9, 2006
Health Authority: Czech Republic: State Institute for Drug Control
Poland: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
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
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Tedisamil
Anti-Arrhythmia Agents
Cardiotonic Agents
Cardiovascular Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014