Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter Recurrence
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ClinicalTrials.gov Identifier: NCT00267930 |
Recruitment Status :
Completed
First Posted : December 22, 2005
Last Update Posted : December 18, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atrial Fibrillation | Drug: Vernakalant (oral) Drug: Placebo comparator | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 221 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A Pilot Phase II, Randomised, Double-Blind, Placebo-Controlled, Multi-Centred Safety, Tolerability and Preliminary Efficacy Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter (AF/AFL) Recurrence in Subjects Post-Conversion Form AF |
Study Start Date : | December 2005 |
Actual Study Completion Date : | August 2006 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: 1
Tier 1: 1 placebo capsule b.i.d Tier 2: 2 placebo capsules b.i.d
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Drug: Placebo comparator |
Experimental: 2
Tier 1: Vernakalant (oral) 1 x 300 mg capsule b.i.d
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Drug: Vernakalant (oral)
Other Name: RSD1235-SR |
Experimental: 3
Tier 2: Vernakalant (oral) 2 x 300 mg (600 mg) b.i.d
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Drug: Vernakalant (oral)
Other Name: RSD1235-SR |
- All subjects who were exposed to the investigational medication were evaluated for safety. [ Time Frame: Subjects were assessed for safety within Day 58 of dosing ]
- Recurrence of AF/AFL or withdrawal [ Time Frame: Time for recurrence of AF/AFL or withdrawal within Day 28 of dosing ]
- Improvement in AF symptoms [ Time Frame: Time to improvement in AF symptoms within Day 28 of dosing ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00267930

Study Director: | Greg Beatch, PhD | Advanz Pharma |
Responsible Party: | Gregory Beatch, Ph.D., Vice President, Scientific Affairs, Cardiome Pharma Corp. |
ClinicalTrials.gov Identifier: | NCT00267930 |
Other Study ID Numbers: |
1235-SR-1005 |
First Posted: | December 22, 2005 Key Record Dates |
Last Update Posted: | December 18, 2008 |
Last Verified: | December 2008 |
AFib AF |
Atrial Fibrillation Atrial Flutter Recurrence Arrhythmias, Cardiac |
Heart Diseases Cardiovascular Diseases Pathologic Processes Disease Attributes |