Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-02-24 @ 5:42 AM
Study NCT ID:
NCT00468767
Status:
COMPLETED
Last Update Posted:
2008-04-02
First Post:
2007-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C524581', 'term': 'vernakalant'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 356}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-31', 'studyFirstSubmitDate': '2007-05-01', 'studyFirstSubmitQcDate': '2007-05-02', 'lastUpdatePostDateStruct': {'date': '2008-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.', 'timeFrame': 'The proportion of patients with atrial fibrillation (AF) of 3 hours to 7 days duration who have treatment-induced conversion of AF to sinus rhythm for a minimum duration of one minute in the first 90 minutes after the first exposure to study treatment.'}], 'secondaryOutcomes': [{'measure': 'To assess the safety of RSD1235 in this patient population.', 'timeFrame': 'The proportion of patients with AF of 3 hours to 45 days duration who have treatment-induced conversion of AF to sinus rhythm for a minimum duration of one minute in the first 90 minutes after the first exposure to study treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'RSD1235', 'Atrial fibrillation of 3 hours to 7 days duration.', 'Atrial fibrillation of 3 hours to 45 days duration.'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '21175515', 'type': 'DERIVED', 'citation': 'Stiell IG, Dickinson G, Butterfield NN, Clement CM, Perry JJ, Vaillancourt C, Calder LA. Vernakalant hydrochloride: A novel atrial-selective agent for the cardioversion of recent-onset atrial fibrillation in the emergency department. Acad Emerg Med. 2010 Nov;17(11):1175-82. doi: 10.1111/j.1553-2712.2010.00915.x.'}, {'pmid': '18332267', 'type': 'DERIVED', 'citation': 'Roy D, Pratt CM, Torp-Pedersen C, Wyse DG, Toft E, Juul-Moller S, Nielsen T, Rasmussen SL, Stiell IG, Coutu B, Ip JH, Pritchett EL, Camm AJ; Atrial Arrhythmia Conversion Trial Investigators. Vernakalant hydrochloride for rapid conversion of atrial fibrillation: a phase 3, randomized, placebo-controlled trial. Circulation. 2008 Mar 25;117(12):1518-25. doi: 10.1161/CIRCULATIONAHA.107.723866. Epub 2008 Mar 10.'}]}, 'descriptionModule': {'briefSummary': 'This study is being conducted to demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.', 'detailedDescription': "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.\n\nThis 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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older;\n* Have an atrial arrhythmia with symptoms that has been sustained for greater than 3 hours and up to 45 days.\n* Have adequate anticoagulant therapy.\n\nExclusion Criteria:\n\n* Have a QRS \\> 0.14 seconds unless patient has pacemaker or uncorrected QT \\> 0.440 seconds as measured on a 12-lead ECG.\n* Have serious diseases/illnesses that could interfere with the conduct or validity of the study or compromise patient safety.\n* Have received intravenous Class I or Class III antiarrhythmic drugs or intravenous amiodarone within 24 hours prior to dosing.'}, 'identificationModule': {'nctId': 'NCT00468767', 'acronym': 'ACT I', 'briefTitle': 'Phase III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Advanz Pharma'}, 'officialTitle': 'A Phase III Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation', 'orgStudyIdInfo': {'id': '1235-0703'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Atrial fibrillation (AF) duration of 3 hours to 7 days.', 'interventionNames': ['Drug: Vernakalant Injection 20 mg/mL']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'AF duration of \\>7 days to \\<45 days', 'interventionNames': ['Drug: Vernakalant Injection 20 mg/mL']}], 'interventions': [{'name': 'Vernakalant Injection 20 mg/mL', 'type': 'DRUG', 'otherNames': ['RSD1235; Vernakalant; Vernakalant Injection; Vernakalant (iv)'], 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Regional Cardiology Associates', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Heart Institute', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'James Haley VA Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '02459', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Cardiac Arrhythmia Service, Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48910', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Thoracic and Cardiovascular Institute', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '97201', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19096', 'city': 'Wynnewood', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Main Line Health Heart Center', 'geoPoint': {'lat': 40.00289, 'lon': -75.27074}}, {'zip': '23219', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Medical College of Virginia', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'McGuire VA Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marshfield Clinic', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}, {'zip': 'T2E 7C5', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Heart Health Institute, Rockyview General Hospital', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T2N 4N1', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V8R 4R2', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Cardiac Arrhythmia Trials', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences, Hamilton General Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K1Y 4E9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Hospitals (Civic & General)', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre, Emergency Medicine Research Program', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut de Cardiologie de Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Notre-Dame du CHUM', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2W 1T8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUM-Hotel-Dieu de Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G5', 'city': 'Ste Foy', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institute de Cardiologie de Quebec, Hopital Laval'}, {'zip': 'J6V 2H2', 'city': 'Terrebonne', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier LeGardeur', 'geoPoint': {'lat': 45.70004, 'lon': -73.64732}}, {'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg University', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Århus Amtssygehus, Med. kardiologisk', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Amager Hospital, Med. 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