Study of RSD1235 to Evaluate Safety in Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— ACT 4  

Official title:

A Phase 3, Multi-Center, Open Label, Safety Study of RSD1235 in Subjects With Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00281554
• Other study ID #: 05-7-012
• Status: Completed
• Phase: Phase 3
• First received: January 24, 2006
• Last updated: April 1, 2008
• Start date: October 2005
• Est. completion date: January 2007

Study information

• Verified date: April 2008
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaCanada: Health CanadaSweden: Medical Products AgencyDenmark: Danish Medicines AgencySouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

This study is designed to determine the safety of RSD1235 in patients with atrial fibrillation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject must have symptomatic AF

• Subject must have adequate anticoagulant therapy

Exclusion Criteria:

• Subject may not have Class IV congestive heart failure.

• Subject may not have uncorrected electrolyte imbalance.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• RSD1235
IV

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Cardiome Pharma

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Denmark,  South Africa,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of conversion of atrial fibrillation to sinus rhythm for a minimum of 1 minute		Infusion plus 1.5 hours	No
Secondary	Evaluate safety		End of study	No