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Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter Recurrence
NCT00267930 · View on ClinicalTrials.gov ↗
Study 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
Conditions Studied
Interventions
- DRUG Placebo comparator
- DRUG Vernakalant (oral)
Study Locations (20)
Other
- Aalborg Sygehus Syd — Aalborg
- Aarhus Sygehus Kardiologisk Afd. A — Aarhus
- Bispebjerg Hospital — Copenhagen
- Kardiologisk/endokrinologisk afd. E Frederiksberg Hospital — Frederiksberg
- KAS Gentofte Kardiologisk Afdeling — Hellerup
- KAS Herlev — Herlev
- Sygehus Vendsyssel Hjorring — Hjørring
- Medicinsk Afdeling Kolding Sygehus — Kolding
- Roskilde Amts Sygehus Koge — Køge
- Reinier de Graaf Gasthuis — Delft
- Catharina Ziekenhuis — Eindhoven
- Medisch Spectrum Twente — Enschede
- University Medical Center Groningen (UMCG) — Groningen
- Trial sectie Cardiologie — Heerlen
Alabama
- The Heart Center, P.C. — Huntsville
California
- Cardiovascular Consultants Medical Group, Inc. — Walnut Creek
Pennsylvania
- Penn State Heart & Vascular Institute — Hershey
Wisconsin
- Marshfield Clinic — Marshfield
Alberta
- Foothills Hospital — Calgary
Quebec
- Centre Hospitalier de l'Université de Montréal (CHUM) Hôtel Dieu — Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2005-12 |
| Est. Completion | 2006-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00267930
The ClinicalTrials.gov registry entry for NCT00267930 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 221 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advanz Pharma, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions — of which Placebo comparator is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00267930 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, Alabama, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00267930 about?
NCT00267930 is a clinical study titled "Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter Recurrence". 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
What is the current status of trial NCT00267930?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 221 participants. The study started on 2005-12. Estimated completion is 2006-08.
What conditions does trial NCT00267930 study?
This clinical trial studies the following conditions: Atrial Fibrillation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00267930?
The interventions under investigation include: Placebo comparator (DRUG), Vernakalant (oral) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00267930?
This trial is sponsored by Advanz Pharma, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00267930 being conducted?
This trial has 20 study locations across Alabama, California, Pennsylvania, Wisconsin, Alberta. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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