Ignite Creation Date:
2025-12-25 @ 12:57 AM
Ignite Modification Date:
2025-12-26 @ 1:46 PM
Study NCT ID:
NCT00137293
Status:
TERMINATED
Last Update Posted:
2007-12-10
First Post:
2005-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating GAP-486 in Heart Rhythm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D013575', 'term': 'Syncope'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': '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'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 30}}, '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': 'This study takes place within 24 hours. The measure to determine the effect of the intervention will be the difference in values from the baseline electrophysiology study, and the values obtained after intervention within the test drug.'}], 'secondaryOutcomes': [{'measure': 'This study takes place within 24 hours, and looks at the changes in values of electrophysiology studies, before and after administration of test article.'}]}, 'conditionsModule': {'keywords': ['Arrhythmia, syncope, antiarrhythmic'], 'conditions': ['Arrhythmia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn the effects of a test drug on heart rhythm, and to provide additional data to see if the test drug is well tolerated and safe.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing an electrophysiology study for evaluation of heart rhythm.\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': 'NCT00137293', 'briefTitle': 'Study Evaluating GAP-486 in Heart Rhythm', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Study to Characterize the Acute Electrophysiologic Properties, Safety and Tolerability of GAP-486', 'orgStudyIdInfo': {'id': '3163K1-201'}}, 'armsInterventionsModule': {'interventions': [{'name': 'GAP-486 (ZP-123)', 'type': 'DRUG'}, {'name': '0.9% Sodium Chloride, USP', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'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': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': 'K1Y 4W7', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H1T 1CB', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}}}}