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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00126074

Enrollment

Unknown

Registered

2005-08-02

Start date

2004-10-31

Completion date

2006-03-31

Last updated

2015-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Atrial Flutter

Keywords

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

Brief 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.

Interventions

DRUGTedisamil sesquifumarate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Countries

Bulgaria, Germany, Hungary, Italy, Poland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026