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A Phase II/III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter
NCT00476112 · View on ClinicalTrials.gov ↗
Study Summary
This study will attempt to demonstrate the effectiveness of RSD1235 in the conversion of atrial flutter (AFL) to sinus rhythm.
Conditions Studied
Interventions
- DRUG Vernakalant Injection 20 mg/mL
Study Locations (20)
Other
- Aalborg University — Aalborg
- H:S Bispebjerg Hospital — Copenhagen
- Centralsygehuset Esbjerg Varde — Esbjerg
- Glostrup Amtssygehus — Glostrup Municipality
- Gentofte Amtssygehus — Hellerup
- Herlev Amtssygehus, Kardiologisk — Herlev
- Sygehus Vendsyssel Hjorring — Hjørring
Alberta
- Heart Health Institute, Rockyview General Hospital — Calgary
- University of Calgary — Calgary
- University of Alberta Hospital — Edmonton
Quebec
- Institut de Cardiologie de Montreal — Montreal
- Hopital Notre-Dame du CHUM — Montreal
- CHUM-Hotel-Dieu de Montreal — Montreal
Virginia
- Medical College of Virginia — Richmond
- McGuire VA Medical Center — Richmond
Ontario
- Hamilton Health Sciences, Hamilton General Hospital — Hamilton
- Ottawa Hospitals (Civic & General) — Ottawa
California
- Regional Cardiology Associates — Sacramento
Michigan
- Thoracic and Cardiovascular Institute — Lansing
Wisconsin
- Marshfield Clinic — Marshfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2003-08 |
| Est. Completion | 2004-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00476112
The ClinicalTrials.gov registry entry for NCT00476112 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 60 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 Flutter appearing as the primary indexed condition, and to 1 intervention — of which Vernakalant Injection 20 mg/mL 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: NCT00476112 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, Alberta, Quebec. 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 NCT00476112 about?
NCT00476112 is a clinical study titled "A Phase II/III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter". This study will attempt to demonstrate the effectiveness of RSD1235 in the conversion of atrial flutter (AFL) to sinus rhythm.
What is the current status of trial NCT00476112?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2003-08. Estimated completion is 2004-09.
What conditions does trial NCT00476112 study?
This clinical trial studies the following conditions: Atrial Flutter. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00476112?
The interventions under investigation include: Vernakalant Injection 20 mg/mL (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00476112?
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 NCT00476112 being conducted?
This trial has 20 study locations across California, Michigan, Virginia, Wisconsin, Alberta. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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