Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-27 @ 5:00 AM
Study NCT ID:
NCT00126061
Status:
COMPLETED
Last Update Posted:
2015-01-16
First Post:
2005-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Male Subjects
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'statusVerifiedDate': '2006-03', 'completionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-15', 'studyFirstSubmitDate': '2005-08-01', 'studyFirstSubmitQcDate': '2005-08-01', 'lastUpdatePostDateStruct': {'date': '2015-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'atrial flutter', 'anti-arrhythmic agents', 'conversion to normal sinus rhythm'], 'conditions': ['Atrial Fibrillation', 'Atrial Flutter']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the ability of tedisamil to convert atrial fibrillation or flutter into normal sinus rhythm (NSR) in male patients.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing to sign informed consent before screening examinations are performed and before the study drug is administered\n* Males \\> 18 years of age\n* Subjects with documented (60 second rhythm strip) symptomatic atrial fibrillation or flutter (duration \\> 3 hours and \\< 45 days) at the time of randomization\n* Subjects who are in no distress and hemodynamically stable (supine systolic blood pressure \\> 90 mmHg and diastolic blood pressure \\< 105 mmHg)\n\nExclusion Criteria:\n\n* Acute myocardial infarction and cerebrovascular accidents\n* Coronary and heart failure symptoms\n* Life-threatening ventricular arrhythmias and electrocardiogram (ECG) abnormalities\n* Electrolyte abnormalities\n* Concurrent antiarrhythmic treatments'}, 'identificationModule': {'nctId': 'NCT00126061', 'briefTitle': 'Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solvay Pharmaceuticals'}, 'officialTitle': 'A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety of Intravenous Tedisamil Sesquifumarate in the Rapid Conversion to Normal Sinus Rhythm in Male Subjects With Recent Onset Atrial Fibrillation or Flutter', 'orgStudyIdInfo': {'id': 'S219.3.117'}, 'secondaryIdInfos': [{'id': '2004-000458-22'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Tedisamil sesquifumarate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Site 26', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Site 27', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Site 24', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'city': 'Tullahoma', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Site 25', 'geoPoint': {'lat': 35.36202, 'lon': -86.20943}}, {'city': 'Brno', 'country': 'Czechia', 'facility': 'Site 5', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Pilsen', 'country': 'Czechia', 'facility': 'Site 4', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Site 2', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Site 3', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Site 6', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Site 8', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'city': 'Lodz', 'country': 'Poland', 'facility': 'Site 11', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Lublin', 'country': 'Poland', 'facility': 'Site 10', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Medyczna', 'country': 'Poland', 'facility': 'Site 12'}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Site 7', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Site 9', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Site 13', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Site 14', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Site 15', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Site 16', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Site 17', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Dnipro', 'country': 'Ukraine', 'facility': 'Site 20', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'city': 'Kiev', 'country': 'Ukraine', 'facility': 'Site 18', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Kiev', 'country': 'Ukraine', 'facility': 'Site 21', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Lviv', 'country': 'Ukraine', 'facility': 'Site 19', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}, {'city': 'Odesa', 'country': 'Ukraine', 'facility': 'Site 23', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}, {'city': 'Zaporizhzhya', 'country': 'Ukraine', 'facility': 'Site 22', 'geoPoint': {'lat': 47.85167, 'lon': 35.11714}}], 'overallOfficials': [{'name': 'Global Clinical Director Solvay', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Solvay Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solvay Pharmaceuticals', 'class': 'INDUSTRY'}}}}