Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

Phase III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation

NCT00468767 · View on ClinicalTrials.gov ↗

Study Summary

This study is being conducted to demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.

Conditions Studied

Interventions

  • DRUG Vernakalant Injection 20 mg/mL

Study Locations (20)

Alberta

  • Heart Health Institute, Rockyview General Hospital — Calgary
  • University of Calgary — Calgary
  • University of Alberta Hospital — Edmonton

Ontario

  • Hamilton Health Sciences, Hamilton General Hospital — Hamilton
  • Ottawa Hospitals (Civic & General) — Ottawa
  • Sunnybrook Health Sciences Centre, Emergency Medicine Research Program — Toronto

California

  • University of California — Los Angeles
  • Regional Cardiology Associates — Sacramento

Florida

  • Florida Heart Institute — Orlando
  • James Haley VA Hospital — Tampa

Virginia

  • Medical College of Virginia — Richmond
  • McGuire VA Medical Center — Richmond

Quebec

  • Institut de Cardiologie de Montreal — Montreal
  • Hopital Notre-Dame du CHUM — Montreal

Massachusetts

  • Cardiac Arrhythmia Service, Massachusetts General Hospital — Boston

Michigan

  • Thoracic and Cardiovascular Institute — Lansing

Trial Details

FieldValue
Enrollment Target 356 participants
Start Date 2003-08
Est. Completion 2004-11
Phase Phase 3

Sponsor

Advanz Pharma

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00468767

The ClinicalTrials.gov registry entry for NCT00468767 describes a study currently listed as completed. It is categorized as Phase 3, 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 356 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 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: NCT00468767 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Alberta, Ontario, 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 NCT00468767 about?

NCT00468767 is a clinical study titled "Phase III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation". This study is being conducted to demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.

What is the current status of trial NCT00468767?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 356 participants. The study started on 2003-08. Estimated completion is 2004-11.

What conditions does trial NCT00468767 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 NCT00468767?

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 NCT00468767?

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 NCT00468767 being conducted?

This trial has 20 study locations across California, Florida, Massachusetts, Michigan, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial