Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Cardiome Pharma Astellas Pharma US, Inc. |
---|---|
Information provided by: | Cardiome Pharma |
ClinicalTrials.gov Identifier: | NCT00468767 |
This study is being conducted to demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.
Condition | Intervention | Phase |
---|---|---|
Atrial Fibrillation |
Drug: Vernakalant Injection 20 mg/mL |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase III Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation |
Enrollment: | 356 |
Study Start Date: | August 2003 |
Study Completion Date: | November 2004 |
Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Atrial fibrillation (AF) duration of 3 hours to 7 days.
|
Drug: Vernakalant Injection 20 mg/mL |
2: Experimental
AF duration of >7 days to <45 days
|
Drug: Vernakalant Injection 20 mg/mL |
There are approximately 2 million reported prevalent cases of atrial fibrillation (AF) and atrial flutter in the United States (Heart Disease & Stroke Statistics - 2003 Update, AHA). These arrhythmias may be occasional or sustained. While not directly fatal, these arrhythmias cause discomfort and can lead to stroke or congestive heart failure.
This Phase III trial is Cardiome's first pivotal study with RSD1235. The study seeks to confirm the findings of the Phase II proof-of-concept through demonstration of RSD1235's abilities to convert AF to sinus rhythm. The patient population will include recent onset AF (AF duration of 3 hours to 7 days) and patients with longer AF duration.
This is a double-blind, placebo-controlled, randomized study in patients with AF; stratification will be based on duration of AF. Treatment will be considered successful if there is a treatment-induced conversion of atrial arrhythmia to sinus rhythm for a minimum of 1-minute by Hour 1.5 (Time 0 = start of first infusion). All patients will be evaluated for safety.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Sheila Grant, MBA | Cardiome Pharma |
Responsible Party: | Cardiome Pharma Corp. ( Sheila Grant, VP of Product Development, Vernakalant ) |
Study ID Numbers: | 1235-0703 |
Study First Received: | May 1, 2007 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00468767 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Denmark: Danish Medicines Agency; Sweden: Medical Products Agency |
Atrial fibrillation RSD1235 Atrial fibrillation of 3 hours to 7 days duration. Atrial fibrillation of 3 hours to 45 days duration. |
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Heart Diseases Cardiovascular Diseases Atrial Fibrillation Arrhythmias, Cardiac |