Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-03-02 @ 11:04 PM
Study NCT ID:
NCT00652418
Status:
COMPLETED
Last Update Posted:
2013-10-14
First Post:
2008-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019786', 'term': 'Gadolinium DTPA'}], 'ancestors': [{'id': 'D004369', 'term': 'Pentetic Acid'}, {'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-10', 'studyFirstSubmitDate': '2008-04-01', 'studyFirstSubmitQcDate': '2008-04-02', 'lastUpdatePostDateStruct': {'date': '2013-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic ability', 'timeFrame': 'MRI image in blinded read'}], 'secondaryOutcomes': [{'measure': 'Visibility', 'timeFrame': 'MRI image in blinded read'}, {'measure': 'Diagnostic confidence', 'timeFrame': 'MRI image in blinded read'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Magnevist', 'Magnetic Resonance Angiography', 'Meglumine gadopentetate', 'Determination of effective dose in MRA'], 'conditions': ['Magnetic Resonance Angiography', 'Peripheral Vascular Diseases', 'Peripheral Arterial Diseases']}, 'descriptionModule': {'briefSummary': 'The objective of the study was to compare the efficacy of Magnevist (SH L 451 A) at doses of 0.1 mmol/kg and 0.2 mmol/kg in contrast-enhanced 3D-Magnetic Resonance Angiography in three regions (abdominal, femoral, and leg regions) for visualization of arteries, evaluating 179 not assessable: caused by contrast media in the evaluation of structural abnormalities. Magnevist (SH L 451 A) was administered intravenously in a crossover design in patients with arterial disease in the abdominal to leg regions. The safety of the 0.2 mmol/kg dose was also assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are scheduled to undergo contrast-enhanced 3D-Magnetic Resonance Angiography\n\nExclusion Criteria:\n\n* Patients with an ankle brachial pressure index (ABPI) of 0.3 or less\n* Patients with allergy to contrast media\n* Patients with serious hepatic impairment\n* Patients with serious renal impairment'}, 'identificationModule': {'nctId': 'NCT00652418', 'briefTitle': 'Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Evaluation of a Single Intravenous Injection of Magnevist (SH L 451 A) at 0.1 mmol/kg and 0.2 mmol/kg in Contrast-enhanced 3D-Magnetic Resonance Angiography in Patients With Arterial Disease in the Abdominal to Leg Regions in the Ability of Detecting of Vessel Abnormalities', 'orgStudyIdInfo': {'id': '91396'}, 'secondaryIdInfos': [{'id': '308612'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1', 'interventionNames': ['Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'interventionNames': ['Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)']}], 'interventions': [{'name': 'Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)', 'type': 'DRUG', 'description': 'Magnevist at a dose of 0.1 mmol/kg', 'armGroupLabels': ['Arm 1']}, {'name': 'Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)', 'type': 'DRUG', 'description': 'Magnevist at a dose of 0.2 mmol/kg', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '036-8563', 'city': 'Hirosaki-shi', 'state': 'Aomori', 'country': 'Japan'}, {'zip': '629-0197', 'city': 'Funai-gun', 'state': 'Kyoto', 'country': 'Japan'}, {'zip': '431-3192', 'city': 'Hamamatsu', 'state': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}