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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00126022
• Other study ID #: S219.3.116
• Secondary ID: 2004-000460-27
• Status: Completed
• Phase: Phase 3
• First received: August 1, 2005
• Last updated: January 15, 2015
• Start date: December 2004
• Est. completion date: March 2006

Study information

• Verified date: March 2006
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaCanada: Health CanadaCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesIsrael: Israeli Health Ministry Pharmaceutical AdministrationPoland: Ministry of HealthRomania: State Institute for Drug ControlRussia: Pharmacological Committee, Ministry of HealthSerbia and Montenegro: Agency for Drugs and Medicinal DevicesSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUkraine: State Pharmacological Center - Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter

Intervention

Drug:
• Tedisamil sesquifumarate

Locations

Country	Name	City	State
Argentina	Site 2	Buenos Aires
Argentina	Site 3	Buenos Aires
Argentina	Site 5	Munro
Argentina	Site 4	Tucuman
Czech Republic	Site 8	Brno
Czech Republic	Site 11	Jindrichuv Hradec
Czech Republic	Site 9	Ostrava-Poruba
Czech Republic	Site 10	Plzen
Czech Republic	Site 14	Prague
Czech Republic	Site 6	Prague
Czech Republic	Site 7	Prague
Czech Republic	Site 12	Slany
Czech Republic	Site 13	Usti nad Orlici
Former Serbia and Montenegro	Site 52	Belgrade
Former Serbia and Montenegro	Site 53	Belgrade
Former Serbia and Montenegro	Site 54	Belgrade
Former Serbia and Montenegro	Site 57	Belgrade
Former Serbia and Montenegro	Site 58	Belgrade
Former Serbia and Montenegro	Site 56	Niska Banja
Former Serbia and Montenegro	Site 55	Sremska Kamenica
Germany	Site 15	Bad Nauheim
Germany	Site 17	Gottingen
Germany	Site 16	Halle
Israel	Site 18	Haifa
Israel	Site 19	Jerusalem
Israel	Site 22	Jerusalem
Israel	Site 23	Jerusalem
Israel	Site 20	Tel-Aviv
Israel	Site 21	Tel-Aviv
Poland	Site 26	Bydgoszcz
Poland	Site 32	Bydgoszcz
Poland	Site 30	Lodz
Poland	Site 29	Lublin
Poland	Site 36	Lublin
Poland	Site 31	Medyczna
Poland	Site 33	Szczecin
Poland	Site 24	Warszawa
Poland	Site 25	Warszawa
Poland	Site 27	Warszawa
Poland	Site 28	Warszawa
Poland	Site 34	Wroclaw
Poland	Site 35	Wroclaw
Romania	Site 38	Brasov
Romania	Site 39	Bucharest
Romania	Site 40	Bucharest
Romania	Site 37	Tg. Mures
Russian Federation	Site 41	Moscow
Russian Federation	Site 42	Moscow
Russian Federation	Site 43	Moscow
Russian Federation	Site 44	Moscow
Russian Federation	Site 45	Moscow
Russian Federation	Site 46	Moscow
Russian Federation	Site 47	Moscow
Russian Federation	Site 48	Moscow
Russian Federation	Site 49	Moscow
Russian Federation	Site 51	Moscow
Russian Federation	Site 50	St. Petersburg
Slovakia	Site 60	Banska Bystrica
Slovakia	Site 64	Bratislava
Slovakia	Site 61	Kosice
Slovakia	Site 62	Lucenec
Slovakia	Site 59	Nitra
Slovakia	Site 65	Nove Zamky
Slovakia	Site 63	Presov
South Africa	Site 66	Cape Town
South Africa	Site 67	Cape Town
Ukraine	Site 68	Dnepropetrovsk
Ukraine	Site 69	Dnepropetrovsk
Ukraine	Site 71	Donetsk
Ukraine	Site 72	Donetsk
Ukraine	Site 75	Kharkiv
Ukraine	Site 70	Kiev
Ukraine	Site 73	Kiev
Ukraine	Site 76	Kiev
Ukraine	Site 77	Kiev
Ukraine	Site 74	Lviv
Ukraine	Site 80	Odessa
Ukraine	Site 79	Zaporizhya
Ukraine	Site 78	Zaporozhye
United Kingdom	Site 81	London
United States	Site 82	Tullahoma	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Czech Republic,  Former Serbia and Montenegro,  Germany,  Israel,  Poland,  Romania,  Russian Federation,  Slovakia,  South Africa,  Ukraine,  United Kingdom,