Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 4:32 AM
Study NCT ID:
NCT00915356
Status:
COMPLETED
Last Update Posted:
2012-02-01
First Post:
2009-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intravenous Cardioversion of Atrial Fibrillation (AF) With AZD1305
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'C550721', 'term': 'tert-butyl (2-(7-(2-(4-cyano-2-fluorophenoxy)ethyl)-9-oxa-3,7-diazabicyclo(3.3.1)non3-yl)ethyl)carbamate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicalTrialTransparency@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'AZD1305 Dose Group 1', 'description': 'AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.', 'otherNumAtRisk': 26, 'otherNumAffected': 5, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'AZD1305 Dose Group 2', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.', 'otherNumAtRisk': 45, 'otherNumAffected': 9, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'AZD1305 Dose Group 3', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.', 'otherNumAtRisk': 45, 'otherNumAffected': 8, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'AZD1305 Dose Group 4', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.', 'otherNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Placebo', 'description': 'Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.', 'otherNumAtRisk': 43, 'otherNumAffected': 5, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastritis fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sensation of heaviness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Multiple drug overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Torsade de pointes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiac asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal wall haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dose-response Relationship for QTcF Interval of AZD1305', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1305 Dose Group 1', 'description': 'AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.'}, {'id': 'OG001', 'title': 'AZD1305 Dose Group 2', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.'}, {'id': 'OG002', 'title': 'AZD1305 Dose Group 3', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.'}, {'id': 'OG003', 'title': 'AZD1305 Dose Group 4', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.'}], 'classes': [{'categories': [{'measurements': [{'value': '461', 'groupId': 'OG000', 'lowerLimit': '449', 'upperLimit': '474'}, {'value': '486', 'groupId': 'OG001', 'lowerLimit': '476', 'upperLimit': '495'}, {'value': '490', 'groupId': 'OG002', 'lowerLimit': '480', 'upperLimit': '499'}, {'value': '482', 'groupId': 'OG003', 'lowerLimit': '464', 'upperLimit': '500'}, {'value': '440', 'groupId': 'OG004', 'lowerLimit': '430', 'upperLimit': '450'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At any time post randomisation until end of Holter recording (18-24 hours post start of drug infusion).', 'description': 'QTcF-QT interval corrected for the RR interval (the time elapsing between two consecutive R waves in the electrocardiogram (ECG)) using the Fridericia formula.For each of 3 consecutive beats (5 consecutive beats if AF) a manual measurement, preferably in lead V2, of QTend intervals was done.The mean QT values of the 3 consecutive beats (5 consecutive beats if AF) were, together with RR intervals, date \\& time of the ECG, entered into the eCase Report Form (eCRF).The selected beats had to be marked with calipers and noted together with measured values and calculations on the print-out and signed', 'unitOfMeasure': 'ms', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Conversion of Atrial Fibrillation (AF) and Maintenance of Sinus Rhytm (SR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1305 Dose Group 1', 'description': 'AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.'}, {'id': 'OG001', 'title': 'AZD1305 Dose Group 2', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.'}, {'id': 'OG002', 'title': 'AZD1305 Dose Group 3', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.'}, {'id': 'OG003', 'title': 'AZD1305 Dose Group 4', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '25.1'}, {'value': '17.8', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '32.1'}, {'value': '37.8', 'groupId': 'OG002', 'lowerLimit': '23.8', 'upperLimit': '53.5'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '21.1', 'upperLimit': '78.9'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '8.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 90 minutes from start of infusion', 'description': 'Conversion of AF to SR with maintenance of SR maintained for at least 1 minute', 'unitOfMeasure': 'Percentage of patients converted to SR', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Wide QRS Tachycardias', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1305 Dose Group 1', 'description': 'AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.'}, {'id': 'OG001', 'title': 'AZD1305 Dose Group 2', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.'}, {'id': 'OG002', 'title': 'AZD1305 Dose Group 3', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.'}, {'id': 'OG003', 'title': 'AZD1305 Dose Group 4', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '16', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '7', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of study drug infusion until discharge from hospital on study day 2.', 'description': 'Number of patients with wide QRS tachycardias, determined as significant arrhythmias by an Adjudication Committee (AC). The AC analysed and classified the occurrence of significant arrhythmias (other than AF or AFl) and pauses based on the 12-lead Holter reports. All pauses (≥3 sec) and all wide QRS complex tachycardias (≥3 beats, QRS ≥120 ms, and ≥120 bpm).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Heart Rhythm. Number of Participants With Early Relapse Into AF.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1305 Dose Group 1', 'description': 'AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.'}, {'id': 'OG001', 'title': 'AZD1305 Dose Group 2', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.'}, {'id': 'OG002', 'title': 'AZD1305 Dose Group 3', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.'}, {'id': 'OG003', 'title': 'AZD1305 Dose Group 4', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 5 minutes following investigational product (IP) induced conversion, or direct current (DC) cardioversion, of AF to SR', 'description': 'Early relapse into AF within 5 minutes from obtaining the defined criterion for conversion to SR (i.e.1 minute in SR). Patients never converted are not included in the analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Heart Rhythm. Number of Patients Remaining in SR up to 24 h Following Start of Study Drug Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1305 Dose Group 1', 'description': 'AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.'}, {'id': 'OG001', 'title': 'AZD1305 Dose Group 2', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.'}, {'id': 'OG002', 'title': 'AZD1305 Dose Group 3', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.'}, {'id': 'OG003', 'title': 'AZD1305 Dose Group 4', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '34', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '36', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '10', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '33', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During 24 hours following start of study drug infusion', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Heart Rhythm. Number of Patients Remaining in SR up to 13 to 18 Days Following Study Drug Infusion.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1305 Dose Group 1', 'description': 'AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.'}, {'id': 'OG001', 'title': 'AZD1305 Dose Group 2', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.'}, {'id': 'OG002', 'title': 'AZD1305 Dose Group 3', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.'}, {'id': 'OG003', 'title': 'AZD1305 Dose Group 4', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '25', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '7', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '22', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During 13 to 18 days following study drug infusion', 'description': 'Number of patients in SR at day 13-18', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Study the Relationship Between Systemic Exposure and Response, With Special Regards to Conversion of AF to SR and the Effect on the QTcF Interval.', 'timeFrame': 'Since this study is no longer intended to be part of any marketing authorisation application, the analyses addressing this objective were not conducted.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Maximal Observed Plasma Concentration of AZD1305', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1305 Dose Group 1', 'description': 'AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.'}, {'id': 'OG001', 'title': 'AZD1305 Dose Group 2', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.'}, {'id': 'OG002', 'title': 'AZD1305 Dose Group 3', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.'}, {'id': 'OG003', 'title': 'AZD1305 Dose Group 4', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.521', 'groupId': 'OG000', 'lowerLimit': '0.157', 'upperLimit': '0.991'}, {'value': '1.28', 'groupId': 'OG001', 'lowerLimit': '0.374', 'upperLimit': '2.97'}, {'value': '1.39', 'groupId': 'OG002', 'lowerLimit': '0.017', 'upperLimit': '3.17'}, {'value': '1.69', 'groupId': 'OG003', 'lowerLimit': '0.873', 'upperLimit': '3.61'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24 hours following start of study drug infusion', 'description': 'Plasma concentration of AZD1305', 'unitOfMeasure': 'mol/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 10 Hours to 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1305 Dose Group 1', 'description': 'AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.'}, {'id': 'OG001', 'title': 'AZD1305 Dose Group 2', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.'}, {'id': 'OG002', 'title': 'AZD1305 Dose Group 3', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.'}, {'id': 'OG003', 'title': 'AZD1305 Dose Group 4', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Conversion from AF to SR within 90 minutes from start of infusion', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 8 Days - 30 Days.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1305 Dose Group 1', 'description': 'AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.'}, {'id': 'OG001', 'title': 'AZD1305 Dose Group 2', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.'}, {'id': 'OG002', 'title': 'AZD1305 Dose Group 3', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.'}, {'id': 'OG003', 'title': 'AZD1305 Dose Group 4', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Conversion from AF to SR within 90 minutes from start of infusion', 'description': 'Subgroup analysis for patients with duration of current AF episode 8 days - 30 days. Number of patients converting from AF to SR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 31 Days - 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1305 Dose Group 1', 'description': 'AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.'}, {'id': 'OG001', 'title': 'AZD1305 Dose Group 2', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.'}, {'id': 'OG002', 'title': 'AZD1305 Dose Group 3', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.'}, {'id': 'OG003', 'title': 'AZD1305 Dose Group 4', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Conversion from AF to SR within 90 minutes from start of infusion', 'description': 'Subgroup analysis for patients with duration of current AF episode 31 days - 3 months. Number of patients converting from AF to SR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients, Discharged Within 6 h (QTcF ≤500 ms) After Start of Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1305 Dose Group 1', 'description': 'AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.'}, {'id': 'OG001', 'title': 'AZD1305 Dose Group 2', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.'}, {'id': 'OG002', 'title': 'AZD1305 Dose Group 3', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.'}, {'id': 'OG003', 'title': 'AZD1305 Dose Group 4', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '85.2', 'upperLimit': '100.0'}, {'value': '95.5', 'groupId': 'OG001', 'lowerLimit': '84.5', 'upperLimit': '99.4'}, {'value': '91.1', 'groupId': 'OG002', 'lowerLimit': '78.8', 'upperLimit': '97.5'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '73.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '91.2', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Six hours following start of study drug infusion', 'description': 'Percentage, with 95% confidence interval, of patients with QTcF≤500 ms six hours following start of study drug infusion', 'unitOfMeasure': 'Percent of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZD1305 Dose Group 1', 'description': 'AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.'}, {'id': 'FG001', 'title': 'AZD1305 Dose Group 2', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.'}, {'id': 'FG002', 'title': 'AZD1305 Dose Group 3', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.'}, {'id': 'FG003', 'title': 'AZD1305 Dose Group 4', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.'}, {'id': 'FG004', 'title': 'Placebo', 'description': 'Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The 1st patient was enrolled in the study on 25 May 2009, and the last patient completed the study on 4 December 2009. In total, 228 patients were enrolled (at 33 centres) and of the 171 patients randomised 170 patients completed the study. There was no discontinuation of the Investigational Product (IP) due to an Adverse Event (AE) in the study.', 'preAssignmentDetails': 'An enrolment visit (Visit 1) was done within 14 days before scheduled randomisation. Patients who fulfilled criteria and signed the informed consent form, could then be randomised at visit 2. The patients were to have ongoing Atrial Fibrillation with a clinical indication for cardioversion of Atrial Fibrillation (AF).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}, {'value': '171', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'AZD1305 Dose Group 1', 'description': 'AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.'}, {'id': 'BG001', 'title': 'AZD1305 Dose Group 2', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.'}, {'id': 'BG002', 'title': 'AZD1305 Dose Group 3', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.'}, {'id': 'BG003', 'title': 'AZD1305 Dose Group 4', 'description': 'AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.'}, {'id': 'BG004', 'title': 'Placebo', 'description': 'Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'title': 'Age (years)', 'categories': [{'measurements': [{'value': '65', 'spread': '9', 'groupId': 'BG000'}, {'value': '65', 'spread': '7', 'groupId': 'BG001'}, {'value': '64', 'spread': '10', 'groupId': 'BG002'}, {'value': '66', 'spread': '7', 'groupId': 'BG003'}, {'value': '66', 'spread': '9', 'groupId': 'BG004'}, {'value': '65', 'spread': '8', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '62', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '109', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 228}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-02', 'studyFirstSubmitDate': '2009-06-05', 'resultsFirstSubmitDate': '2011-01-24', 'studyFirstSubmitQcDate': '2009-06-05', 'lastUpdatePostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-01-02', 'studyFirstPostDateStruct': {'date': '2009-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-response Relationship for QTcF Interval of AZD1305', 'timeFrame': 'At any time post randomisation until end of Holter recording (18-24 hours post start of drug infusion).', 'description': 'QTcF-QT interval corrected for the RR interval (the time elapsing between two consecutive R waves in the electrocardiogram (ECG)) using the Fridericia formula.For each of 3 consecutive beats (5 consecutive beats if AF) a manual measurement, preferably in lead V2, of QTend intervals was done.The mean QT values of the 3 consecutive beats (5 consecutive beats if AF) were, together with RR intervals, date \\& time of the ECG, entered into the eCase Report Form (eCRF).The selected beats had to be marked with calipers and noted together with measured values and calculations on the print-out and signed'}, {'measure': 'Conversion of Atrial Fibrillation (AF) and Maintenance of Sinus Rhytm (SR)', 'timeFrame': 'Within 90 minutes from start of infusion', 'description': 'Conversion of AF to SR with maintenance of SR maintained for at least 1 minute'}], 'secondaryOutcomes': [{'measure': 'Wide QRS Tachycardias', 'timeFrame': 'From start of study drug infusion until discharge from hospital on study day 2.', 'description': 'Number of patients with wide QRS tachycardias, determined as significant arrhythmias by an Adjudication Committee (AC). The AC analysed and classified the occurrence of significant arrhythmias (other than AF or AFl) and pauses based on the 12-lead Holter reports. All pauses (≥3 sec) and all wide QRS complex tachycardias (≥3 beats, QRS ≥120 ms, and ≥120 bpm).'}, {'measure': 'Heart Rhythm. Number of Participants With Early Relapse Into AF.', 'timeFrame': 'Within 5 minutes following investigational product (IP) induced conversion, or direct current (DC) cardioversion, of AF to SR', 'description': 'Early relapse into AF within 5 minutes from obtaining the defined criterion for conversion to SR (i.e.1 minute in SR). Patients never converted are not included in the analysis.'}, {'measure': 'Heart Rhythm. Number of Patients Remaining in SR up to 24 h Following Start of Study Drug Infusion', 'timeFrame': 'During 24 hours following start of study drug infusion'}, {'measure': 'Heart Rhythm. Number of Patients Remaining in SR up to 13 to 18 Days Following Study Drug Infusion.', 'timeFrame': 'During 13 to 18 days following study drug infusion', 'description': 'Number of patients in SR at day 13-18'}, {'measure': 'Study the Relationship Between Systemic Exposure and Response, With Special Regards to Conversion of AF to SR and the Effect on the QTcF Interval.', 'timeFrame': 'Since this study is no longer intended to be part of any marketing authorisation application, the analyses addressing this objective were not conducted.'}, {'measure': 'Maximal Observed Plasma Concentration of AZD1305', 'timeFrame': 'Up to 24 hours following start of study drug infusion', 'description': 'Plasma concentration of AZD1305'}, {'measure': 'Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 10 Hours to 7 Days', 'timeFrame': 'Conversion from AF to SR within 90 minutes from start of infusion'}, {'measure': 'Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 8 Days - 30 Days.', 'timeFrame': 'Conversion from AF to SR within 90 minutes from start of infusion', 'description': 'Subgroup analysis for patients with duration of current AF episode 8 days - 30 days. Number of patients converting from AF to SR.'}, {'measure': 'Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 31 Days - 3 Months', 'timeFrame': 'Conversion from AF to SR within 90 minutes from start of infusion', 'description': 'Subgroup analysis for patients with duration of current AF episode 31 days - 3 months. Number of patients converting from AF to SR.'}, {'measure': 'Percentage of Patients, Discharged Within 6 h (QTcF ≤500 ms) After Start of Infusion', 'timeFrame': 'Six hours following start of study drug infusion', 'description': 'Percentage, with 95% confidence interval, of patients with QTcF≤500 ms six hours following start of study drug infusion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['AZD1305', 'intravenous cardioversion of Atrial Fibrillation'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '21561900', 'type': 'DERIVED', 'citation': 'Ronaszeki A, Alings M, Egstrup K, Gaciong Z, Hranai M, Kiraly C, Sereg M, Figatowski W, Bondarov P, Johansson S, Frison L, Edvardsson N, Berggren A. Pharmacological cardioversion of atrial fibrillation--a double-blind, randomized, placebo-controlled, multicentre, dose-escalation study of AZD1305 given intravenously. Europace. 2011 Aug;13(8):1148-56. doi: 10.1093/europace/eur120. Epub 2011 May 11.'}]}, 'descriptionModule': {'briefSummary': 'This study is being carried out to see which dose of AZD1305 is safe and effective in cardioverting atrial fibrillation into normal heart rhythm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical indication for cardioversion of Atrial Fibrillation, ie a correction of irregular heart rhythm to normal heart rhythm\n* Current episode of Atrial Fibrillation (ie irregular heart rhythm) lasting up to 3 months at randomisation\n* Adequate anticoagulation according to international guidelines (ACC/AHA/ESC, 2006) or national guidelines\n\nExclusion Criteria:\n\n* Potassium level below 3.8 mmol/L measured in serum or plasma\n* QTcF interval \\>440 ms'}, 'identificationModule': {'nctId': 'NCT00915356', 'briefTitle': 'Intravenous Cardioversion of Atrial Fibrillation (AF) With AZD1305', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Double-blind, Randomised, Placebo-controlled, Multicentre, Dose-escalating Study of AZD1305 Given Intravenously for Cardioversion of Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'D3191C00009'}, 'secondaryIdInfos': [{'id': '2009-009862-15 (EudraCT No)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'AZD1305 iv infusion', 'interventionNames': ['Drug: AZD1305']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo iv infusion', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD1305', 'type': 'DRUG', 'description': 'Intravenous (iv) single infusion given intravenously until successful conversion of Atrial Fibrillation (AF) to Sinus Rhythm (SR) occur or for a maximum of 30 minutes', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'iv single infusion given intravenously until successful conversion of Atrial Fibrillation (AF) to Sinus Rhythm (SR) occur or for a maximum of 30 minutes', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brno', 'state': 'CZ', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Znojmo', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 48.8555, 'lon': 16.0488}}, {'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'city': 'Esbjerg', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}, {'city': 'Svendborg', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.05982, 'lon': 10.60677}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 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'Research Site', 'geoPoint': {'lat': 53.01375, 'lon': 18.59814}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Martin', 'country': 'Slovakia', 'facility': 'Research Site', 'geoPoint': {'lat': 49.06651, 'lon': 18.92399}}, {'city': 'Nitra', 'country': 'Slovakia', 'facility': 'Research Site', 'geoPoint': {'lat': 48.30763, 'lon': 18.08453}}, {'city': 'Ružomberok', 'country': 'Slovakia', 'facility': 'Research Site', 'geoPoint': {'lat': 49.0748, 'lon': 19.30751}}, {'city': 'Linköping', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'city': 'Örebro', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'AZD1305 Medical Science Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D, Mölndal, Sweden'}, {'name': 'Aladár Rónaszéki', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Péterfy HospitalDepartment of Cardiology1076 Budapest, Péterfi Sándor str. 8-20HUNGARY'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}