Intravenous Tedisamil in the Rapid Conversion of Atrial F... | NCT00126022

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

NCT00126022

Sponsor

Solvay Pharmaceuticals

Status

Completed

Last Update Posted

Jan 16, 2015Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Atrial Fibrillation
Atrial Flutter

Interventions

Tedisamil sesquifumarate

Countries

United States
Argentina
Czechia
Germany
Israel
Poland
Romania
Russia
Serbia and Montenegro
Slovakia
South Africa
Ukraine
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2004-000460-27

Status Module

Record Verification Date

Mar 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Dec 2004

Primary Completion Date

Mar 2006Actual

Completion Date

Mar 2006Actual

First Submitted Date

Aug 1, 2005

First Submission Date that Met QC Criteria

Aug 1, 2005

First Posted Date

Aug 2, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2015

Last Update Posted Date

Jan 16, 2015Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Tedisamil sesquifumarate	Drug

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Director Solvay	Solvay Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Site 82		Tullahoma	Tennessee		United States
Site 2

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms