Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
Study NCT ID:
NCT00244504
Status:
TERMINATED
Last Update Posted:
2009-11-10
First Post:
2005-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Moxonidine in Patients Undergoing Vascular Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C043482', 'term': 'moxonidine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}}, 'statusModule': {'whyStopped': 'Study was stopped after pre-definied interim analysis because of no effects', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-09', 'studyFirstSubmitDate': '2005-10-25', 'studyFirstSubmitQcDate': '2005-10-25', 'lastUpdatePostDateStruct': {'date': '2009-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'over-all mortality', 'timeFrame': '30 days and 12 months'}], 'secondaryOutcomes': [{'measure': 'Ischemia detected by Holter-ECG ST alterations or troponin T elevation', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cardiac Disease', 'Vascular Surgery']}, 'referencesModule': {'references': [{'pmid': '17968979', 'type': 'DERIVED', 'citation': 'Bolliger D, Seeberger MD, Lurati Buse GA, Christen P, Gurke L, Filipovic M. Randomized clinical trial of moxonidine in patients undergoing major vascular surgery. Br J Surg. 2007 Dec;94(12):1477-84. doi: 10.1002/bjs.6012.'}]}, 'descriptionModule': {'briefSummary': 'Investigating the perioperative effect of moxonidine. In a randomized double-blind fashion, patients undergoing vascular surgery will receive moxonidine 0.2 mg or placebo from the day before surgery until day 4 after surgery. Holter-EKG for 48 h, starting just before surgery. Repeated 12-lead EKG, measurements of Troponin I and BNP, clinical visitations, follow-up interviews at 6 and 12 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* abdominal aortic or peripheral vascular surgery\n\nExclusion Criteria:\n\n* unstable angina,\n* severe symptomatic heart failure (NYHA IV)\n* systolic blood pressure at rest \\< 100 mmHg\n* bradycardia (\\<50/min)\n* higher grade AV heart block\n* creatinine clearance \\< 30 ml/min\n* pregnancy\n* no consent'}, 'identificationModule': {'nctId': 'NCT00244504', 'briefTitle': 'Moxonidine in Patients Undergoing Vascular Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'The Effects of Small Doses of Moxonidine in Patients Undergoing Vascular Surgery', 'orgStudyIdInfo': {'id': '158/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'I', 'description': 'moxonidine group', 'interventionNames': ['Drug: moxonidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'II', 'description': 'placebo group', 'interventionNames': ['Drug: moxonidine']}], 'interventions': [{'name': 'moxonidine', 'type': 'DRUG', 'otherNames': ['Physiotens'], 'description': 'moxonidine 0.2 mg/d starting the morning of surgery until day 4 after surgery', 'armGroupLabels': ['I', 'II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Basel', 'state': 'CH', 'country': 'Switzerland', 'facility': 'University hospital', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Miodrag Filipovic, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'PD Dr. M. Filipovic, Co-Head of Cardiothoracic Anaesthesia'}}}}