Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter Recurrence
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| ClinicalTrials.gov Identifier: NCT00267930 |
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Recruitment Status :
Completed
First Posted : December 22, 2005
Last Update Posted : December 18, 2008
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Sponsor:
Cardiome Pharma
Information provided by:
Cardiome Pharma
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Brief Summary:
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
| 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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
| Arm | Intervention/treatment |
|---|---|
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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 |
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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 |
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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 |
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- 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 ]
Information from the National Library of Medicine
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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 |
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
Information from the National Library of Medicine
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
Locations
| United States, Alabama | |
| The Heart Center, P.C. | |
| Huntsville, Alabama, United States, 35801 | |
| United States, California | |
| Cardiovascular Consultants Medical Group, Inc. | |
| Walnut Creek, California, United States, 94598 | |
| United States, Pennsylvania | |
| Penn State Heart & Vascular Institute | |
| Hershey, Pennsylvania, United States, 17033 | |
| United States, Wisconsin | |
| Marshfield Clinic | |
| Marshfield, Wisconsin, United States, 54449 | |
| Canada, Alberta | |
| Foothills Hospital | |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Canada, Quebec | |
| Centre Hospitalier de l'Université de Montréal (CHUM) Hôtel Dieu | |
| Montréal, Quebec, Canada, H2W 1T8 | |
| Denmark | |
| Aalborg Sygehus Syd | |
| Aalborg, Denmark, 9100 | |
| Aarhus Sygehus Kardiologisk Afd. A | |
| Aarhus, Denmark, 8000 | |
| Kardiologisk/endokrinologisk afd. E Frederiksberg Hospital | |
| Frederiksberg, Denmark, 2000 | |
| KAS Gentofte Kardiologisk Afdeling | |
| Hellerup, Denmark | |
| KAS Herlev | |
| Herlev, Denmark, 2730 | |
| Sygehus Vendsyssel Hjorring | |
| Hjorring, Denmark, 9800 | |
| Bispebjerg Hospital | |
| Kobenhavn, Denmark | |
| Roskilde Amts Sygehus Koge | |
| Koge, Denmark, 4600 | |
| Medicinsk Afdeling Kolding Sygehus | |
| Kolding, Denmark, 6000 | |
| Netherlands | |
| Reinier de Graaf Gasthuis | |
| Delft, Netherlands | |
| Catharina Ziekenhuis | |
| Eindhoven, Netherlands | |
| Medisch Spectrum Twente | |
| Enschede, Netherlands | |
| University Medical Center Groningen (UMCG) | |
| Groningen, Netherlands | |
| Trial sectie Cardiologie | |
| Heerlen, Netherlands | |
| Academisch Ziekenhuis Maastricht | |
| Maastricht, Netherlands | |
| Stichting Sint Antonius Ziekenhuis | |
| Nieuwegein, Netherlands | |
Sponsors and Collaborators
Cardiome Pharma
Investigators
| Study Director: | Greg Beatch, PhD | Cardiome Pharma |
Additional Information:
| Responsible Party: | Gregory Beatch, Ph.D., Vice President, Scientific Affairs, Cardiome Pharma Corp. |
| ClinicalTrials.gov Identifier: | NCT00267930 History of Changes |
| 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 |
Keywords provided by Cardiome Pharma:
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AFib AF |
Additional relevant MeSH terms:
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Atrial Fibrillation Recurrence Atrial Flutter Arrhythmias, Cardiac |
Heart Diseases Cardiovascular Diseases Pathologic Processes Disease Attributes |