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CompletedNCT00126061Updated Jan 16, 2015

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

A Phase 3 interventional study of Tedisamil sesquifumarate in Atrial Fibrillation and Atrial Flutter, sponsored by Solvay Pharmaceuticals. Completed at 26 sites in 5 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-16.

Sponsored by Solvay Pharmaceuticals (part of Abbott) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

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 male patients.

02

Conditions studied

  • Atrial Fibrillation
  • Atrial Flutter

Keywords

  • Atrial fibrillation
  • atrial flutter
  • anti-arrhythmic agents
  • conversion to normal sinus rhythm
03

In context

Atrial Fibrillation

3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

Browse Atrial Fibrillation studies →

Lead sponsor

Solvay Pharmaceuticals is the lead sponsor of 86 studies on the registry; none are open to participants now.

First submitted before Solvay Pharmaceuticals became part of Abbott.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double

Interventions

06

Study locations

26 sites
  • Site 26
    Los Angeles, California, United States
  • Site 27
    Santa Ana, California, United States
  • Site 24
    Honolulu, Hawaii, United States
  • Site 25
    Tullahoma, Tennessee, United States
  • Site 5
    Brno, Czechia
  • Site 4
    Pilsen, Czechia
  • Site 2
    Prague, Czechia
  • Site 3
    Prague, Czechia
  • Site 6
    Prague, Czechia
  • Site 8
    Bydgoszcz, Poland
  • Site 11
    Lodz, Poland
  • Site 10
    Lublin, Poland
  • Site 12
    Medyczna, Poland
  • Site 7
    Warsaw, Poland
  • Site 9
    Warsaw, Poland
  • Site 13
    Moscow, Russia
  • Site 14
    Moscow, Russia
  • Site 15
    Moscow, Russia
  • Site 16
    Moscow, Russia
  • Site 17
    Moscow, Russia
  • Site 20
    Dnipro, Ukraine
  • Site 18
    Kiev, Ukraine
  • Site 21
    Kiev, Ukraine
  • Site 19
    Lviv, Ukraine
  • Site 23
    Odesa, Ukraine
  • Site 22
    Zaporizhzhya, Ukraine
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2004, a primary completion of Jan 2006 and a completion of Jan 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 1, 2005
First posted
Aug 2, 2005
Start
Oct 2004
Primary completionActual
Jan 2006
CompletionActual
Jan 2006
Last update
Jan 16, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00126061
First posted
Aug 2, 2005
Start date
Oct 2004
Primary completion
Jan 2006
Completion
Jan 2006
Last update
Jan 16, 2015

Study contacts

Global Clinical Director Solvay
study director · Solvay Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2006. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Tedisamil sesquifumarate

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