Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-27 @ 5:17 AM
Study NCT ID:
NCT00389792
Status:
COMPLETED
Last Update Posted:
2009-03-11
First Post:
2006-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of an Antiarrhythmic Drug to Treat Atrial Fibrillation in Patients With Pacemakers
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': 'C499879', 'term': 'celivarone'}]}}, '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': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-10', 'studyFirstSubmitDate': '2006-10-17', 'studyFirstSubmitQcDate': '2006-10-17', 'lastUpdatePostDateStruct': {'date': '2009-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy Measure: Atrial Fibrillation Burden'}, {'measure': 'Safety Measures: ECG, Laboratory and Adverse Events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and efficacy of an investigational antiarrhythmic drug (ATI-2042) in the treatment of atrial fibrillation in patients with a dual chamber pacemaker.', 'detailedDescription': 'ATI-2042 is being developed as an alternative to amiodarone, which is considered a first-line therapy for patients with atrial fibrillation and is known to have serious side effects. ATI-2042 was designed to have a reduced plasma half-life and a lower volume of distribution, which is expected to result in an improved safety profile. In contrast to amiodarone, ATI-2042 undergoes rapid metabolism via plasma and tissue esterases, which may reduce tissue accumulation and toxicity. The current trial will determine if ATI-2042 retains the efficacy profile of amiodarone without the side effects attributable to tissue accumulation seen with long-term dosing.\n\nThis study is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants.)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Proven paroxysmal atrial fibrillation\n* Pacemaker with appropriate AF diagnostics and recording capabilities\n\nExclusion Criteria:\n\n* Known allergy to Amiodarone or previous treatment for severe Amiodarone toxicity\n* Cardioversion within one month of screening\n* Severe left ventricular dysfunction or CHF with NYHA Class III or above'}, 'identificationModule': {'nctId': 'NCT00389792', 'briefTitle': 'Efficacy and Safety Study of an Antiarrhythmic Drug to Treat Atrial Fibrillation in Patients With Pacemakers', 'organization': {'class': 'INDUSTRY', 'fullName': 'ARYx Therapeutics'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study of ATI-2042 in Patients With Paroxysmal Atrial Fibrillation and Pacemakers With Atrial Fibrillation Data Logging Capabilities', 'orgStudyIdInfo': {'id': 'ATI 2042-CLN 205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'ATI-2042 200 mg', 'interventionNames': ['Drug: ATI-2042', 'Drug: ATI-2042 200 mg']}, {'type': 'NO_INTERVENTION', 'label': 'ATI-2042 400 mg', 'interventionNames': ['Drug: ATI-2042', 'Drug: ATI-2042 200 mg']}, {'type': 'NO_INTERVENTION', 'label': 'ATI-2042 600 mg', 'interventionNames': ['Drug: ATI-2042', 'Drug: ATI-2042 200 mg']}, {'type': 'NO_INTERVENTION', 'label': 'ATI-2042 Placebo', 'interventionNames': ['Drug: ATI-2042', 'Drug: ATI-2042 200 mg']}], 'interventions': [{'name': 'ATI-2042', 'type': 'DRUG', 'description': 'no intervention', 'armGroupLabels': ['ATI-2042 200 mg', 'ATI-2042 400 mg', 'ATI-2042 600 mg', 'ATI-2042 Placebo']}, {'name': 'ATI-2042 200 mg', 'type': 'DRUG', 'description': 'To stop the dosing of ATI-2042 for a designated time frame as determined by the medical monitor and Principal Investigator.', 'armGroupLabels': ['ATI-2042 200 mg', 'ATI-2042 400 mg', 'ATI-2042 600 mg', 'ATI-2042 Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85306', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'ARYx Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'ARYx Investigational Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85715', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'ARYx Investigational Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94939', 'city': 'Larkspur', 'state': 'California', 'country': 'United States', 'facility': 'ARYx Investigational Site', 'geoPoint': {'lat': 37.93409, 'lon': -122.53525}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'ARYx Investigational Site', 'geoPoint': {'lat': 39.72943, 'lon': 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