Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT00137332
Status:
TERMINATED
Last Update Posted:
2007-12-10
First Post:
2005-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating GAP-486 on Heart Rhythm in Patients With Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'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': 'C477643', 'term': 'rotigaptide'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 90}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-11'}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-06', 'studyFirstSubmitDate': '2005-08-25', 'studyFirstSubmitQcDate': '2005-08-25', 'lastUpdatePostDateStruct': {'date': '2007-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The measure to determine the effect of the intervention will be whether abnormally fast heart rhythm can be induced after test drug is administered.'}], 'secondaryOutcomes': [{'measure': 'This study takes place within 24 hours, and looks at whether the test article makes a difference in inducing the abnormally fast heart rhythm during a 24 hour observational period.'}]}, 'conditionsModule': {'keywords': ['Arrhythmia', 'antiarrhythmic', 'programmed electrical stimulation'], 'conditions': ['Arrhythmia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn the effects of a test drug on heart rhythms, which may become life-threatening if left untreated, and to provide data to see if the drug is well tolerated and safe.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with or without ICDs (implantable cardioverter defibrillators)\n* Patients undergoing an electrophysiology study for evaluation of ventricular rhythm\n* Patients with a history of heart disease\n\nExclusion Criteria:\n\n* Patients with uncontrolled blood pressure\n* Patients with certain cardiac risk factors\n* Patients with significant kidney or liver problems'}, 'identificationModule': {'nctId': 'NCT00137332', 'briefTitle': 'Study Evaluating GAP-486 on Heart Rhythm in Patients With Coronary Artery Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Study of the Effects GAP-486 on Ventricular Tachyarrhythmia Induction', 'orgStudyIdInfo': {'id': '3163K1-202'}}, 'armsInterventionsModule': {'interventions': [{'name': 'GAP-486 (ZP-123)', 'type': 'DRUG'}, {'name': '0.9% Sodium Chloride, USP', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 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