Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-29 @ 6:00 AM
Study NCT ID:
NCT01213368
Status:
COMPLETED
Last Update Posted:
2013-10-16
First Post:
2010-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Ranging Study of Dronedarone for the Control of Ventricular Rate in Japanese Patients With Permanent 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': 'D000077764', 'term': 'Dronedarone'}], 'ancestors': [{'id': 'D000638', 'term': 'Amiodarone'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 181}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-12', 'studyFirstSubmitDate': '2010-09-30', 'studyFirstSubmitQcDate': '2010-09-30', 'lastUpdatePostDateStruct': {'date': '2013-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in mean ventricular rate measured by 24-hour Holter Electrocardiogram (ECG)', 'timeFrame': 'Day 14'}], 'secondaryOutcomes': [{'measure': 'Number of patients with adverse events', 'timeFrame': 'up to 10 days after last drug intake'}, {'measure': 'Plasma trough concentrations for SR33589', 'timeFrame': 'Day 14'}, {'measure': 'Plasma trough concentrations for SR35021', 'timeFrame': 'Day 14'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\n\\- To assess the efficacy of dronedarone versus placebo for the control of ventricular rate in patients with permanent Atrial Fibrillation (AF).\n\nSecondary Objective:\n\n* To assess the safety and tolerability of dronedarone after repeated oral doses of 300 mg, 400 mg, or 600 mg twice daily in the selected population.\n* To document SR33589 and SR35021 trough plasma levels at steady state.', 'detailedDescription': 'The study period per patient is approximatively 1 month broken down as follows:\n\n* Screening period up to 7 days,\n* Treatment period of 14 days,\n* Follow-up period of 10 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Patients of aged 20 years or more.\n* Permanent Atrial Fibrillation \\[AF\\] (defined as duration of AF \\> 6 months) for which cardioversion is not considered and with resting ventricular heart rate ≥ 80 bpm at screening.\n\nExclusion criteria:\n\n* Unstable angina pectoris.\n* History of torsades de pointes.\n* Prolonged QT corrected interval (≥ 500 ms).\n* Third degree atrioventricular block (AVB) on the screening ECG while in AF or, documentation on previous ECGs while in sinus rhythm of PR-interval \\> 0.28 sec or high degree AVB (2nd degree or higher) or, significant sinus node disease (documented pause ≥ 3 sec) - without a permanent pacemaker implanted.\n* Congestive Heart Failure (CHF) of New York Heart Association classification (NYHA) class IV or recent (within 1 month prior to randomization) unstable NYHA class III.\n* Treatment with other class I or III anti-arrhythmic drugs.\n* Patients treated with amiodarone during the 4 weeks preceding randomization.\n* Clinically relevant haematologic, hepatic, gastro-intestinal, renal, pulmonary, endocrinologic (in particular thyroid) or psychiatric disease.\n* Hypokalemia and hypomagnesemia must be corrected before randomization.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01213368', 'briefTitle': 'Dose Ranging Study of Dronedarone for the Control of Ventricular Rate in Japanese Patients With Permanent Atrial Fibrillation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Double Blind, Randomized, Placebo Controlled Dose Ranging Study of the Efficacy and Safety of Dronedarone (SR33589B) at 300, 400, or 600 mg BID for the Control of Ventricular Rate in Japanese Patients With Permanent Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'DRI10939'}, 'secondaryIdInfos': [{'id': 'U1111-1116-9409', 'type': 'OTHER', 'domain': '(UTN)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dronedarone 300 mg', 'description': 'Dronedarone, 100mg + 200mg tablets twice daily, administered with food.', 'interventionNames': ['Drug: DRONEDARONE (SR33589)']}, {'type': 'EXPERIMENTAL', 'label': 'dronedarone 400 mg', 'description': 'Dronedarone, 400mg tablets twice daily, administered with food.', 'interventionNames': ['Drug: DRONEDARONE (SR33589)']}, {'type': 'EXPERIMENTAL', 'label': 'dronedarone 600 mg', 'description': 'Dronedarone, 400mg + 200mg tablets twice daily, administered with food.', 'interventionNames': ['Drug: DRONEDARONE (SR33589)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Matching placebo tablets twice daily, administered with food.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'DRONEDARONE (SR33589)', 'type': 'DRUG', 'description': 'Pharmaceutical form: tablets\n\nRoute of administration: oral', 'armGroupLabels': ['dronedarone 300 mg', 'dronedarone 400 mg', 'dronedarone 600 mg']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form: tablets\n\nRoute of administration: oral', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Investigational Site Number 392022', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Kagoshima', 'country': 'Japan', 'facility': 'Investigational Site Number 392018', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kasama-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392005'}, {'city': 'Kawanishi-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392014'}, {'city': 'Kawasaki-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392008'}, {'city': 'Kisarazu-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392007'}, {'city': 'Kobe', 'country': 'Japan', 'facility': 'Investigational Site Number 392012', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'city': 'Kobe', 'country': 'Japan', 'facility': 'Investigational Site Number 392013', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'city': 'Koriyama-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392003'}, {'city': 'Kurume-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392017'}, {'city': 'Miyazaki', 'country': 'Japan', 'facility': 'Investigational Site Number 392023', 'geoPoint': {'lat': 31.91667, 'lon': 131.41667}}, {'city': 'Nagano', 'country': 'Japan', 'facility': 'Investigational Site Number 392009', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'city': 'Nagasaki', 'country': 'Japan', 'facility': 'Investigational Site Number 392019', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Investigational Site Number 392010', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Sapporo', 'country': 'Japan', 'facility': 'Investigational Site Number 392021', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sapporo', 'country': 'Japan', 'facility': 'Investigational Site Number 392025', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sendai', 'country': 'Japan', 'facility': 'Investigational Site Number 392002', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Shirakawa-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392004'}, {'city': 'Shunan-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392016'}, {'city': 'Suwa-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392020'}, {'city': 'Takasaki-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392006'}, {'city': 'Tomakomai-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392001'}, {'city': 'Toshima-Ku', 'country': 'Japan', 'facility': 'Investigational Site Number 392024'}, {'city': 'Ube-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392015'}, {'city': 'Yakushi', 'country': 'Japan', 'facility': 'Investigational Site Number 392011', 'geoPoint': {'lat': 32.04135, 'lon': 130.62864}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}