Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-31 @ 3:06 AM
Study NCT ID:
NCT01067833
Status:
TERMINATED
Last Update Posted:
2011-05-16
First Post:
2010-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2 Study of Oral K201 for Prevention of AF Recurrence
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': 'C109183', 'term': 'K201 compound'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-05-13', 'studyFirstSubmitDate': '2010-02-10', 'studyFirstSubmitQcDate': '2010-02-10', 'lastUpdatePostDateStruct': {'date': '2011-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to first documented recurrence of symptomatic AF', 'timeFrame': '28 days'}, {'measure': 'time to first documented recurrence of symptomatic or asymptomatic AF', 'timeFrame': '28 days'}, {'measure': 'proportion of subjects in sinus rhythm', 'timeFrame': 'Day 28'}, {'measure': 'number of AF beats', 'timeFrame': '10 days'}, {'measure': 'time in AF', 'timeFrame': '10 days'}, {'measure': 'safety assessments: vital signs, laboratory assays, ECG parameters, physical exams, frequency of adverse events', 'timeFrame': '42 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'AF'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety, efficacy, and tolerability of 3 doses of K201 (oral) administered for up to 28 days in subjects with recent DC cardioversion to sinus rhythm from sustained symptomatic atrial fibrillation (AF duration \\>3 days and \\<6 months).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic AF (sustained \\>3 days and \\<6 months) and clinically indicated for cardioversion;\n* Adequate anticoagulant therapy for cardioversion in accordance with standard practice as recommended by ACC/AHA/ESC guidelines or with local clinical practice;\n* Hemodynamically stable (90 mmHg \\< systolic blood pressure \\< 190 mmHg)at screening and on Day 1;\n\nExclusion Criteria:\n\n* Known prolonged QT syndrome or QTc interval of \\>0.500 sec at screening; familial long QT syndrome; previous Torsade de Pointes; ventricular fibrillation; or sustained ventricular tachycardia (VT);\n* QRS \\>0.130 sec;\n* Previous episodes of second- or third-degree atrioventricular block;\n* Unsuccessful DC cardioversion attempt within 3 months; prior ablation for AF;\n* Persistent bradycardia with ventricular rate below 50 beats/min, sick-sinus syndrome or pacemaker (including CRT, AICD);\n* Myocardial infarction (MI), cardiac surgery, angioplasty, unstable angina or acute coronary syndrome within 30 days prior to entry into the study;\n* NYHA Class III or Class IV heart failure (HF) at screening or admission, or hospitalized for HF in previous 6 months;\n* Known concurrent temporary secondary causes of AF;\n* Received a Class I or Class III antiarrhythmic agent (including sotalol) within 5 half-lives of randomization or amiodarone or dronedarone within 4 weeks;\n* Received treatment with other drugs known to prolong the QT interval within 5 half-lives.'}, 'identificationModule': {'nctId': 'NCT01067833', 'acronym': 'ARCTIC-AF', 'briefTitle': 'Phase 2 Study of Oral K201 for Prevention of AF Recurrence', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sequel Pharmaceuticals, Inc'}, 'officialTitle': 'A Pilot Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Centered Safety, Tolerability and Preliminary EffiCacy Study of K201 Oral for the Prevention of ATrial FIbrillation (AF) Recurrence in Subjects Post-Conversion From AF', 'orgStudyIdInfo': {'id': 'CJO-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 1', 'description': 'K201', 'interventionNames': ['Drug: K201 Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2', 'description': 'K201', 'interventionNames': ['Drug: K201 Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 3', 'description': 'K201', 'interventionNames': ['Drug: K201 Tablet']}], 'interventions': [{'name': 'K201 Tablet', 'type': 'DRUG', 'description': 'oral tablet, x28 days', 'armGroupLabels': ['Dose 1', 'Dose 2', 'Dose 3']}, {'name': 'Placebo Tablet', 'type': 'DRUG', 'description': 'oral tablet, x28 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Paul Chamberlin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sequel Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sequel Pharmaceuticals, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Howard C. Dittrich, CMO', 'oldOrganization': 'Sequel Pharmaceuticals, Inc'}}}}