Study of RSD1235 to Evaluate Safety in Patients With Atrial Fibrillation (ACT 4)

Astellas

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation

Treatments: Drug: RSD1235

Study type: Interventional

Funder types: Industry

Identifiers

NCT00281554

05-7-012

Details and patient eligibility

About

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

Enrollment: 254 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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254 participants in 1 patient group

1

Experimental group

Treatment:

Drug: RSD1235