Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-02-20 @ 5:56 PM
Study NCT ID:
NCT00644592
Status:
TERMINATED
Last Update Posted:
2012-06-01
First Post:
2008-03-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
LXRA Gene Polymorphisms and Response to Fenofibrate
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011345', 'term': 'Fenofibrate'}], 'ancestors': [{'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D007659', 'term': 'Ketones'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fryerf@ufl.edu', 'phone': '3522735453', 'title': 'Reginald F. Frye, PhD, Associate Professor', 'organization': 'University of Florida'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 Weeks on Treatment', 'eventGroups': [{'id': 'EG000', 'title': '1-Fenofibrate', 'description': '4 weeks of drug at 160 mg orally per day', 'otherNumAtRisk': 11, 'otherNumAffected': 2, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2 Placebo', 'description': '4 weeks of placebo.', 'otherNumAtRisk': 11, 'otherNumAffected': 2, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal', 'notes': 'Abdominal Complaints', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED CT'}, {'term': 'Rash', 'notes': 'Skin rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED CT'}, {'term': 'Nausea/Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED CT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Log(ENA-Period 2 End/ENA Period 1 End)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1-Fenofibrate Then Placebo', 'description': '4 weeks of drug at 160 mg orally per day'}, {'id': 'OG001', 'title': '2 Placebo Then Fenofibrate', 'description': '4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.298', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '0.178', 'spread': '0.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of mean effects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '1.06', 'ciUpperLimit': '1.52', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'estimateComment': 'The estimated mean log difference (SE) between the period 2 and period 1 effects and SE was estimated. This estimates twice the effect size\\[since (B-A)-(A-B)=2B-2A\\] so the actual estimate was based upon the antilog of half of this difference.', 'groupDescription': 'This is a crossover analysis. To convert to a ratio effect, the mean difference must be divided by two and antilogs take. The outcome represents a relative effect.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'week 12 to week 4', 'description': 'Log of the ratio of Period end ENA-78 Period 2:Period 1. Once the confidence interval is obtained, we take antilogs to obtain a ratio of effects.\n\nNatural logs used', 'unitOfMeasure': 'Log of Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent was to enroll 30 but drug was withdrawn by provider, with only 11 completing both experimental periods'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1-Fenofibrate Then Placebo', 'description': '4 weeks of drug at 160 mg orally per day'}, {'id': 'FG001', 'title': '2 Placebo Then Fenofibrate', 'description': '4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'UF Clinical Research Center. Started March 2008, completed August 2009.', 'preAssignmentDetails': 'Patients were screened for eligibility.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '1-Fenofibrate Then Placebo', 'description': '4 weeks of drug at 160 mg orally per day'}, {'id': 'BG001', 'title': '2 Placebo Then Fenofibrate', 'description': '4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.2', 'spread': '17.1', 'groupId': 'BG000'}, {'value': '26.0', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '27.5', 'spread': '11.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'supply issues with the formulation of fenofibrate that was used.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-24', 'studyFirstSubmitDate': '2008-03-21', 'resultsFirstSubmitDate': '2012-03-12', 'studyFirstSubmitQcDate': '2008-03-25', 'lastUpdatePostDateStruct': {'date': '2012-06-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-23', 'studyFirstPostDateStruct': {'date': '2008-03-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Log(ENA-Period 2 End/ENA Period 1 End)', 'timeFrame': 'week 12 to week 4', 'description': 'Log of the ratio of Period end ENA-78 Period 2:Period 1. Once the confidence interval is obtained, we take antilogs to obtain a ratio of effects.\n\nNatural logs used'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy Volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a research study of how a cholesterol medication known as fenofibrate works differently in people with different genetic backgrounds. "Genetics" refers to certain things that are passed to a person by their parents, such as eye color or hair color. Genetic differences lead to people having different eye and hair color. There are also genetic differences in a protein called liver X receptor-alpha (LXRA), which may be important in predicting the response to fenofibrate.', 'detailedDescription': 'This is a double blind crossover study of fenofibrate vs. placebo in healthy volunteers. The null hypothesis is that over a four week period, fenofibrate (160mg/day orally) is equivalent to placebo in terms of relative changes in cytokines ENA-78 and MCP-1 over a four week periods, separated by a four week washout. ENA-78 is a marker of inflammation. See http://en.wikipedia.org/wiki/CXCL5 for more details.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Triglycerides equal to or above 150mg/dL or Low HDL (below 44 mg/dl for men or below 54 mg/dl for women)\n* Must be able to swallow tablets\n\nExclusion Criteria:\n\n* Known Coronary Heart Disease, symptomatic carotid artery disease, abdominal aortic aneurysm, diabetes, or Framingham risk score above 20%\n* Pregnancy, malignancy, liver dysfunction, renal dysfunction, active alcohol abuse, history of unexplained muscle pain\n* Current treatment with lipid lowering therapy, estrogens, androgens, progestins, thiazide diuretics, beta-blockers, glucocorticoids (other than inhaled), antihistamines, or chronic anti-inflammatory drugs\n* Current treatment with the following the interacting drugs: ursodeoxycholic acid, ursodiol, cholestyramine, red yeast rice, glyburide, glipizide, warfarin, or cyclosporine'}, 'identificationModule': {'nctId': 'NCT00644592', 'briefTitle': 'LXRA Gene Polymorphisms and Response to Fenofibrate', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'LXRA Gene Polymorphisms and Response to Fenofibrate', 'orgStudyIdInfo': {'id': '302-2007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1-Fenofibrate then Placebo', 'description': '4 weeks of drug at 160 mg orally per day, 4 week washout, then 4 weeks of placebo', 'interventionNames': ['Drug: Fenofibrate capsule daily for 4 weeks', 'Drug: Fenofibrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 Placebo then Fenofibrate', 'description': '4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.', 'interventionNames': ['Drug: Fenofibrate capsule daily for 4 weeks', 'Drug: Fenofibrate']}], 'interventions': [{'name': 'Fenofibrate capsule daily for 4 weeks', 'type': 'DRUG', 'description': 'Placebo capsule daily for 4 weeks', 'armGroupLabels': ['1-Fenofibrate then Placebo', '2 Placebo then Fenofibrate']}, {'name': 'Fenofibrate', 'type': 'DRUG', 'description': '160 mg/day orally for 4 weeks', 'armGroupLabels': ['1-Fenofibrate then Placebo', '2 Placebo then Fenofibrate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida College of Pharmacy, Center for Pharmacogenomics', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Issam Zineh, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida College of Pharmacy, Department of Pharmacy Practice, Center for Pharmacogenomics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'American College of Clinical Pharmacy', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}