Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT00320502
Status:
COMPLETED
Last Update Posted:
2008-08-25
First Post:
2006-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 2 Study to Determine the Effects of BXT-51072 in Diabetic Patients Undergoing Angioplasty (PCI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C114695', 'term': 'BXT 51072'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-08-21', 'studyFirstSubmitDate': '2006-04-30', 'studyFirstSubmitQcDate': '2006-05-01', 'lastUpdatePostDateStruct': {'date': '2008-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in CK-MB'}, {'measure': 'Safety'}], 'secondaryOutcomes': [{'measure': 'Change in troponin'}, {'measure': 'Myocardial ischemia by 24-hour continuous 12-lead ECG'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome', 'Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and feasibility of BXT-51072 as a cardioprotective agent in diabetics undergoing elective angioplasty / percutaneous intervention (PCI), a procedure to "open" coronary arteries.\n\nBXT-51072 belongs to a class of drugs called "glutathione peroxidase mimics." BXT-51072 works by imitating a substance produced in various tissues in the body, which prevents damage of the heart and blood vessels.', 'detailedDescription': 'Following screening, baseline measurements and informed consent, patients will receive BXT-51072 40 mg or placebo in a 2:1 ratio, 30 minutes before their scheduled PCI and then three times per day for 2 days. There will be 5 treatment visits and 3 follow-up visits.\n\nBlood samples will be obtained for CK-MB, troponin and routine chemistry. A 24-hour continuous electrocardiogram will be obtained following the PCI and regular electrocardiograms will be obtained during the study and follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* Scheduled for elective angioplasty with acute coronary syndrome within 72- hours or MI within 7 days\n\nExclusion Criteria:\n\n* CK-MB above normal\n* Elevated troponin not showing a decreasing value\n* Congestive heart failure\n* Atrial fibrillation or left bundle branch block\n* Uncontrolled diabetes'}, 'identificationModule': {'nctId': 'NCT00320502', 'briefTitle': 'A Phase 2 Study to Determine the Effects of BXT-51072 in Diabetic Patients Undergoing Angioplasty (PCI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Synvista Therapeutics, Inc'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Effects of BXT-51072 on CK-MB in High-Risk Type 2 Diabetic Patients Undergoing Elective Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'BXT-203'}}, 'armsInterventionsModule': {'interventions': [{'name': 'BXT-51072', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '22100', 'city': 'Nahariya', 'country': 'Israel', 'facility': 'Western Galilee Hospital', 'geoPoint': {'lat': 33.00892, 'lon': 35.09814}}, {'zip': '13100', 'city': 'Safed', 'country': 'Israel', 'facility': 'Rivka Sieff Hospital', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}, {'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Shmuel Banai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sourasky Medical Center, Tel Aviv, Israel'}, {'name': 'Ariel Roguin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Medical Center, Haifa, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Synvista Therapeutics, Inc', 'class': 'INDUSTRY'}}}}