Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-01-03 @ 9:16 PM
Study NCT ID:
NCT01472692
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
2011-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Febuxostat Effect on Blood Pressure in Patients With High Normal Blood Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058246', 'term': 'Prehypertension'}, {'id': 'D006073', 'term': 'Gout'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069465', 'term': 'Febuxostat'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '(858) 552-8585', 'title': 'Department of Medicine', 'organization': 'UCSD'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The Principal Investigator for this study has passed away and the results data is not available.'}}, 'adverseEventsModule': {'description': 'The Principal Investigator for this study has passed away and the results data is not available.', 'eventGroups': [{'id': 'EG000', 'title': 'Febuxostat', 'description': 'Febuxostat: 80mg PO daily for 8 weeks', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Febuxostat: 80mg PO daily for 8 weeks', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in 24 Hour Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Febuxostat', 'description': 'Febuxostat: 80mg PO daily for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Febuxostat: 80mg PO daily for 8 weeks'}], 'timeFrame': '8 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'The Principal Investigator for this study has passed away and the results data is not available.'}, {'type': 'PRIMARY', 'title': 'Changes in Pulse Wave Velocity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Febuxostat', 'description': 'Febuxostat: 80mg PO daily for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Febuxostat: 80mg PO daily for 8 weeks'}], 'timeFrame': '8 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'The Principal Investigator for this study has passed away and the results data is not available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Febuxostat', 'description': 'Febuxostat: 80mg PO daily for 8 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Febuxostat: 80mg PO daily for 8 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The Principal Investigator for this study has passed away and the results data is not available.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Febuxostat', 'description': 'Febuxostat: 80mg PO daily for 8 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Febuxostat: 80mg PO daily for 8 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}]}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}], 'populationDescription': 'The Principal Investigator for this study has passed away and the results data is not available.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-26', 'studyFirstSubmitDate': '2011-11-13', 'resultsFirstSubmitDate': '2019-11-26', 'studyFirstSubmitQcDate': '2011-11-15', 'lastUpdatePostDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-26', 'studyFirstPostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in 24 Hour Blood Pressure', 'timeFrame': '8 weeks'}, {'measure': 'Changes in Pulse Wave Velocity', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prehypertension', 'Gout', 'Puls Wave Velocity', 'Hypertension', '24 hour blood pressure'], 'conditions': ['Prehypertension', 'Gout', 'Pulse Wave Velocity', 'Hypertension', '24 Hour Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '32877573', 'type': 'DERIVED', 'citation': 'Gois PHF, Souza ERM. Pharmacotherapy for hyperuricaemia in hypertensive patients. Cochrane Database Syst Rev. 2020 Sep 2;9(9):CD008652. doi: 10.1002/14651858.CD008652.pub4.'}]}, 'descriptionModule': {'briefSummary': 'High normal blood pressure, also called prehypertension, is a significant problem. High uric acid in the blood, the same thing that causes gout, may cause higher blood pressures. The investigators plan to monitor the effects of the drug febuxostat(trade name Uloric) on blood pressure and stiffness of the main blood vessels and see if lowering uric acid has any effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prehypertensive male and female subjects with SBP =120-140 mmHg or DBP =80-90 mmHg (as determined by seated office BP).\n* Plasma uric acid level ≥5 mg/dl\n* Ages 18-50\n* non-smokers\n* Subjects will need to remain in the San Diego area for the duration of the study and be accessible by telephone or email.\n\nExclusion Criteria:\n\n* no current smoking in the prior 6 months.\n* Any history of any serious medical conditions requiring close monitoring from physicians- such as liver impairment, chronic kidney disease, or diabetes mellitus. Participants not currently under the care of a physician for these conditions will be eligible for the study.\n* Any history of gout, hypertension, hypercholesterolemia, morbid obesity.\n* Any history of use xanthine oxidase inhibitors, antihypertensives, antiglycemic, and cholesterol lowering medications\n* any history of illicit drug use within the last 6 months'}, 'identificationModule': {'nctId': 'NCT01472692', 'briefTitle': 'Study of Febuxostat Effect on Blood Pressure in Patients With High Normal Blood Pressure', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Treatment of Uric Acid With the Xanthine Oxidase Inhibitor Febuxostat: Effects on Blood Pressure, Metabolic Markers, and Aortic Stiffness in Prehypertensive', 'orgStudyIdInfo': {'id': '110806'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Febuxostat', 'interventionNames': ['Drug: Febuxostat']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Febuxostat']}], 'interventions': [{'name': 'Febuxostat', 'type': 'DRUG', 'otherNames': ['Uloric'], 'description': '80mg PO daily for 8 weeks', 'armGroupLabels': ['Febuxostat', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Univerisity Of California San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': "Daniel O'Connor, UCSD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD'}, {'name': 'Jason T. Davis, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of California, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}