Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT00125320
Status:
COMPLETED
Last Update Posted:
2007-12-24
First Post:
2005-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-19', 'studyFirstSubmitDate': '2005-07-28', 'studyFirstSubmitQcDate': '2005-07-28', 'lastUpdatePostDateStruct': {'date': '2007-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of RSD1235', 'timeFrame': '90 minutes post infusion'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients in sinus rhythm at 90 minutes', 'timeFrame': 'Time from first exposure to conversion to sinus rhythm'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Treatment'], 'conditions': ['Atrial Fibrillation', 'Atrial Flutter']}, 'referencesModule': {'references': [{'pmid': '19948506', 'type': 'DERIVED', 'citation': 'Kowey PR, Dorian P, Mitchell LB, Pratt CM, Roy D, Schwartz PJ, Sadowski J, Sobczyk D, Bochenek A, Toft E; Atrial Arrhythmia Conversion Trial Investigators. Vernakalant hydrochloride for the rapid conversion of atrial fibrillation after cardiac surgery: a randomized, double-blind, placebo-controlled trial. Circ Arrhythm Electrophysiol. 2009 Dec;2(6):652-9. doi: 10.1161/CIRCEP.109.870204.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the safety and efficacy of RSD1235 compared to placebo in the conversion of atrial arrhythmia to sinus rhythm in subjects following valvular and/or coronary artery bypass graft surgery.', 'detailedDescription': 'This multi-national, multi-center study is a double blind, randomized, placebo-controlled trial with 2 parallel treatment arms (1 active, 1 placebo) to assess the conversion efficacy and safety of 2 intravenous doses of RSD1235 in subjects with atrial fibrillation or atrial flutter following valvular and/or coronary artery bypass graft (CABG) surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented atrial arrhythmia after valvular and/or coronary artery bypass graft surgery\n\nExclusion Criteria:\n\n* Unstable Class IV heart failure'}, 'identificationModule': {'nctId': 'NCT00125320', 'briefTitle': 'Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase III Study of the Conversion Efficacy and Safety of Repeated Intravenous Doses of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter Following Valvular and/or Coronary Artery Bypass Graft Surgery', 'orgStudyIdInfo': {'id': '1235-0104'}}, 'armsInterventionsModule': {'interventions': [{'name': 'RSD1235', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'La Plata', 'country': 'Argentina', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2W 1T8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '9000', 'city': 'Aalborg', 'state': 'DK', 'country': 'Denmark', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '2900', 'city': 'Hellerup', 'state': 'DK', 'country': 'Denmark', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}, {'zip': '5000', 'city': 'Odense C', 'state': 'DK', 'country': 'Denmark', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}, {'zip': '562 158', 'city': 'Bangalore', 'country': 'India', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '600 037', 'city': 'Chennai', 'country': 'India', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '500 001', 'city': 'Hyderabaad', 'country': 'India'}, {'zip': '682 026', 'city': 'Kerala', 'country': 'India'}, {'zip': '160 062', 'city': 'Mohali', 'country': 'India', 'geoPoint': {'lat': 30.67995, 'lon': 76.72211}}, {'zip': '400 051', 'city': 'Mumbai', 'country': 'India', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '110 025', 'city': 'New Delhi', 'country': 'India', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '40-635', 'city': 'Katowice', 'country': 'Poland', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '31-202', 'city': 'Krakow', 'country': 'Poland', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '91-425', 'city': 'Lodz', 'country': 'Poland', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma US, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Astellas Pharma US, Inc.', 'class': 'INDUSTRY'}, {'name': 'Advanz Pharma', 'class': 'INDUSTRY'}]}}}