Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT00476112
Status:
COMPLETED
Last Update Posted:
2008-04-02
First Post:
2007-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase II/III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001282', 'term': 'Atrial Flutter'}], '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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-31', 'studyFirstSubmitDate': '2007-05-18', 'studyFirstSubmitQcDate': '2007-05-18', 'lastUpdatePostDateStruct': {'date': '2008-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To demonstrate the effectiveness of RSD1235 in the conversion of AFL to sinus rhythm. Treatment will be considered successful if there is treatment-induced conversion of AFL to sinus rhythm for a minimum of 1 minute duration by Hour 1.5.', 'timeFrame': 'The proportion of patients with atrial flutter who have treatment-induced conversion of atrial flutter 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 and to assess the efficacy of RSD1235 in lowering the ventricular response rate in patients with AFL.', 'timeFrame': 'Treatment-induced reduction of the ventricular response rate within 50 minutes of first exposure to treatment for patient with atrial flutter.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atrial flutter', 'RSD1235'], 'conditions': ['Atrial Flutter']}, 'referencesModule': {'references': [{'pmid': '22291438', 'type': 'DERIVED', 'citation': 'Camm AJ, Toft E, Torp-Pedersen C, Vijayaraman P, Juul-Moller S, Ip J, Beatch GN, Dickinson G, Wyse DG; Scene 2 Investigators. Efficacy and safety of vernakalant in patients with atrial flutter: a randomized, double-blind, placebo-controlled trial. Europace. 2012 Jun;14(6):804-9. doi: 10.1093/europace/eur416. Epub 2012 Jan 29.'}]}, 'descriptionModule': {'briefSummary': 'This study will attempt to demonstrate the effectiveness of RSD1235 in the conversion of atrial flutter (AFL) to sinus rhythm.', 'detailedDescription': "There are approximately 2 million reported prevalent cases of atrial fibrillation and atrial flutter (AFL) in the United States (Heart Disease \\& Stroke Statistics - 2003 Update, AHA). These arrhythmias may be occasional or sustained. AF/AFL is usually associated with age, and general physical condition, rather than with a specific cardiac event, as is often the case with ventricular arrhythmia. While not directly fatal, these arrhythmias cause discomfort and can lead to stroke or congestive heart failure.\n\nThis Phase II/III trial is Cardiome's first study with RSD1235 for the treatment of atrial flutter. The study seeks to demonstrate RSD1235's abilities to convert AFL to sinus rhythm. The patient population will have atrial flutter of duration greater than 3 hours and less than or equal to 45 days.\n\nThis is a double-blind, placebo-controlled, randomized study in patients with AFL; stratification will be based on duration of AFL. 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 dysrhythmic 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 s unless patient has pacemaker or uncorrected QT \\> 0.440 seconds as measured on a 12-lead ECG.\n* Be concurrently participating in another drug study or have received an investigational drug within 30 days prior to enrollment, or have previously received RSD1235.\n* Have serious diseases/illnesses that could interfere with the conduct or validity of the study or compromise patient safety.\n* Have received IV Class I or Class III antiarrhythmic drugs or IV amiodarone within 24 hours prior to dosing.'}, 'identificationModule': {'nctId': 'NCT00476112', 'acronym': 'Scene 2', 'briefTitle': 'A Phase II/III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter', 'organization': {'class': 'INDUSTRY', 'fullName': 'Advanz Pharma'}, 'officialTitle': 'A Phase II/III Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter', 'orgStudyIdInfo': {'id': '1235-0703B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Atrial flutter duration of 3 hours 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']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Regional Cardiology Associates', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '48910', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Thoracic and Cardiovascular Institute', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'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': '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': '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}}, {'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg University', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'H:S Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Esbjerg', 'country': 'Denmark', 'facility': 'Centralsygehuset Esbjerg Varde', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}, {'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'Glostrup Amtssygehus', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}, {'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Gentofte Amtssygehus', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}, {'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev Amtssygehus, Kardiologisk', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'city': 'Hjørring', 'country': 'Denmark', 'facility': 'Sygehus Vendsyssel Hjorring', 'geoPoint': {'lat': 57.46417, 'lon': 9.98229}}, {'city': 'Holstebro', 'country': 'Denmark', 'facility': 'Holstebro centralsygehus', 'geoPoint': {'lat': 56.36009, 'lon': 8.61607}}, {'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Hvidovre Hospital, Kardiologisk', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'city': 'Malmo', 'country': 'Sweden', 'facility': 'Universitetssjukhuset MAS', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'city': 'Västerås', 'country': 'Sweden', 'facility': 'Centrallasarettet, Vasteras', 'geoPoint': {'lat': 59.61617, 'lon': 16.55276}}], 'overallOfficials': [{'name': 'Sheila Grant, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Advanz Pharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Advanz Pharma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Astellas Pharma US, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Sheila Grant, VP of Product Development, Vernakalant', 'oldOrganization': 'Cardiome Pharma Corp.'}}}}