Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter Recurrence

Advanz Pharma

Status and phase: Completed; Phase 2

Conditions: Atrial Fibrillation

Treatments: Drug: Vernakalant (oral); Drug: Placebo comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT00267930

1235-SR-1005

Details and patient eligibility

About

This study is designed to evaluate the safety, tolerability and preliminary efficacy of vernakalant (oral) in subjects with sustained atrial fibrillation of greater than 72 hours and less than 6 months duration

Enrollment: 221 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (partial list):

• Subjects must have sustained, symptomatic atrial fibrillation for greater than 72 hours and less than 6 months duration
• Subjects must have adequate anticoagulant therapy

Exclusion Criteria (partial list):

• Subjects may not have Class III or Class IV congestive heart failure
• Subjects may not have uncorrected electrolyte imbalance

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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221 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Tier 1: 1 placebo capsule b.i.d Tier 2: 2 placebo capsules b.i.d

Treatment:

Drug: Placebo comparator

2

Experimental group

Description:

Tier 1: Vernakalant (oral) 1 x 300 mg capsule b.i.d

Treatment:

Drug: Vernakalant (oral)

3

Experimental group

Description:

Tier 2: Vernakalant (oral) 2 x 300 mg (600 mg) b.i.d

Treatment:

Drug: Vernakalant (oral)