Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-27 @ 12:40 AM
Study NCT ID:
NCT01280604
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2011-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Fenofibrate Conversion on Triglyceride Levels in Patients on Statin Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, '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': 'manigault_kr@mercer.edu', 'phone': '678-547-6216', 'title': 'Kendra Manigault, PharmD, BCPS, BCACP, CDE', 'organization': 'Mercer University/ Kaiser Permanente'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.\n\nFenofibrate 54mg: Subjects will receive fenofibrate 54mg daily.', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).', 'otherNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Triglyceride Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.\n\nFenofibrate 54mg: Subjects will receive fenofibrate 54mg daily.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).'}], 'classes': [{'title': 'Baseline Triglyceride Levels', 'categories': [{'measurements': [{'value': '135.5', 'spread': '36.22', 'groupId': 'OG000'}, {'value': '108.3', 'spread': '37.41', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up Triglyceride Levels', 'categories': [{'measurements': [{'value': '152.7', 'spread': '42.61', 'groupId': 'OG000'}, {'value': '109', 'spread': '39.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-10 weeks', 'description': 'Triglyceride levels will be assessed in study participants 6-10 weeks after entry into study.', 'unitOfMeasure': 'milligram/deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Low-density Lipoprotein (LDL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.\n\nFenofibrate 54mg: Subjects will receive fenofibrate 54mg daily.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).'}], 'classes': [{'title': 'Baseline Low-density lipoprotein', 'categories': [{'measurements': [{'value': '95.32', 'spread': '21.32', 'groupId': 'OG000'}, {'value': '83.29', 'spread': '22.99', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Low-density lipoprotein', 'categories': [{'measurements': [{'value': '84.42', 'spread': '21.05', 'groupId': 'OG000'}, {'value': '78.71', 'spread': '21.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-10 weeks', 'description': 'LDL levels will be assessed in study participants 6-10 weeks after entry into study.', 'unitOfMeasure': 'milligram/deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'High-density Lipoprotein,(HDL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.\n\nFenofibrate 54mg: Subjects will receive fenofibrate 54mg daily.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).'}], 'classes': [{'title': 'Baseline High-density lipoprotein', 'categories': [{'measurements': [{'value': '41.88', 'spread': '9.58', 'groupId': 'OG000'}, {'value': '41.79', 'spread': '14.24', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up High-density lipoprotein', 'categories': [{'measurements': [{'value': '43.21', 'spread': '38.99', 'groupId': 'OG000'}, {'value': '38.79', 'spread': '33.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-10 weeks', 'description': 'HDL levels will be assessed in study participants 6-10 weeks after entry into study.', 'unitOfMeasure': 'milligram/deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Alanine Aminotransferase(ALT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.\n\nFenofibrate 54mg: Subjects will receive fenofibrate 54mg daily.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).'}], 'classes': [{'title': 'Baseline Alanine aminotransferase', 'categories': [{'measurements': [{'value': '29.76', 'spread': '26.20', 'groupId': 'OG000'}, {'value': '30.66', 'spread': '26.61', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Alanine aminotransferase', 'categories': [{'measurements': [{'value': '27.38', 'spread': '9.13', 'groupId': 'OG000'}, {'value': '29.96', 'spread': '11.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-10 weeks', 'description': 'ALT levels will be assessed in study participants 6-10 weeks after entry into study.', 'unitOfMeasure': 'international units/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aspartate Aminotransferase (AST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.\n\nFenofibrate 54mg: Subjects will receive fenofibrate 54mg daily.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).'}], 'classes': [{'title': 'Baseline Aspartate Aminotransferase', 'categories': [{'measurements': [{'value': '27.48', 'spread': '6.14', 'groupId': 'OG000'}, {'value': '27.59', 'spread': '8.57', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Aspartate Aminotransferase', 'categories': [{'measurements': [{'value': '25.5', 'spread': '5.41', 'groupId': 'OG000'}, {'value': '26.36', 'spread': '6.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-10 weeks', 'description': 'AST levels will be assessed in study participants 6-10 weeks after entry into study.', 'unitOfMeasure': 'international units/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Creatinine(SCr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.\n\nFenofibrate 54mg: Subjects will receive fenofibrate 54mg daily.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).'}], 'classes': [{'title': 'Baseline Serum Creatinine', 'categories': [{'measurements': [{'value': '0.9880', 'spread': '0.2571', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Serum Creatinine', 'categories': [{'measurements': [{'value': '1', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-10 weeks', 'description': 'SCr levels will be assessed in study participants 6-10 weeks after entry into study.', 'unitOfMeasure': 'milligram/deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.\n\nFenofibrate 54mg: Subjects will receive fenofibrate 54mg daily.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'Subjects Meeting All Inclusion Criteria', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.\n\nFenofibrate 54mg: Subjects will receive fenofibrate 54mg daily.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.2', 'spread': '8.67', 'groupId': 'BG000'}, {'value': '57.55', 'spread': '9.26', 'groupId': 'BG001'}, {'value': '57.41', 'spread': '8.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-04', 'studyFirstSubmitDate': '2011-01-19', 'resultsFirstSubmitDate': '2014-10-14', 'studyFirstSubmitQcDate': '2011-01-19', 'lastUpdatePostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-04', 'studyFirstPostDateStruct': {'date': '2011-01-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Triglyceride Levels', 'timeFrame': '6-10 weeks', 'description': 'Triglyceride levels will be assessed in study participants 6-10 weeks after entry into study.'}], 'secondaryOutcomes': [{'measure': 'Low-density Lipoprotein (LDL)', 'timeFrame': '6-10 weeks', 'description': 'LDL levels will be assessed in study participants 6-10 weeks after entry into study.'}, {'measure': 'High-density Lipoprotein,(HDL)', 'timeFrame': '6-10 weeks', 'description': 'HDL levels will be assessed in study participants 6-10 weeks after entry into study.'}, {'measure': 'Alanine Aminotransferase(ALT)', 'timeFrame': '6-10 weeks', 'description': 'ALT levels will be assessed in study participants 6-10 weeks after entry into study.'}, {'measure': 'Aspartate Aminotransferase (AST)', 'timeFrame': '6-10 weeks', 'description': 'AST levels will be assessed in study participants 6-10 weeks after entry into study.'}, {'measure': 'Serum Creatinine(SCr)', 'timeFrame': '6-10 weeks', 'description': 'SCr levels will be assessed in study participants 6-10 weeks after entry into study.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hyperlipidemias']}, 'descriptionModule': {'briefSummary': 'The primary objective of this randomized trial is to measure the impact of converting patients on statin therapy from fenofibrate 160mg to 54mg per day compared to patients who continue fenofibrate 160mg per day for triglycerides.', 'detailedDescription': 'Hypothesis: Study subjects receiving fenofibrate 54mg will maintain similar triglyceride levels as patients on 160mg of fenofibrate.\n\nThe primary objective of this randomized trial is to measure the impact of converting patients on statin therapy from fenofibrate 160mg to 54mg per day compared to patients who continue fenofibrate 160mg per day for triglycerides. Secondary objectives include evaluating effect of the dosage change on low-density lipoprotein (LDL), HDL, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and serum creatinine (SCr), and the potential cost savings associated with prescribing 54mg instead of 160mg. Electronic medical records will be used to identify subjects and gather data on demographics, comorbid conditions, and concomitant lipid lowering therapy. Subjects will be recruited for enrollment via telephone by the principal investigator (PI), co-principal investigators (Co-PIs), or provider referral after eligibility screening and approval from their primary care physician. Subjects must provide written informed consent and Health Insurance Privacy and Accountability Act (HIPAA) privacy rule authorization prior to participation in this study. Subjects will be randomized to either the intervention arm (conversion to 54mg of fenofibrate) or to the control arm (remain on 160mg of fenofibrate). Subjects in both study arms will have fasting lipid panels, ALT/AST, and SCr evaluated at baseline. All subjects will have repeat labs approximately 8 weeks after enrollment. All subjects will continue to receive standard care based on lipid values. The study period will begin approximately October 29, 2010 and run to June 30, 2011.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 18 years of age or older\n* Patients actively taking fenofibrate 160mg and statin therapy\n* A fasting lipid panel within the past 9 months with most recent triglycerides levels less than 200mg/dL\n* Primary care physician approves participation and fenofibrate conversion\n\nExclusion Criteria:\n\n* Impaired renal function defined as creatine clearance ≤ 50ml/min\n* Current enrollment in other studies or clinical trials\n* Previous fenofibrate 54mg use\n* A history of pancreatitis or known previous triglyceride levels \\>1000mg/dL\n* Pregnancy\n* Members with plan benefits that include a deductible for lab services at Kaiser Permanente'}, 'identificationModule': {'nctId': 'NCT01280604', 'briefTitle': 'Effect of Fenofibrate Conversion on Triglyceride Levels in Patients on Statin Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Effects of Fenofibrate 160mg to 54mg Conversion on Triglyceride Levels in Patients on Statin Therapy', 'orgStudyIdInfo': {'id': 'KPGA-10KMani-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Intervention 'Fenofibrate 54mg'", 'description': 'Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.', 'interventionNames': ['Drug: Fenofibrate 54mg']}, {'type': 'NO_INTERVENTION', 'label': "Control 'Fenofibrate 160mg'", 'description': 'Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).'}], 'interventions': [{'name': 'Fenofibrate 54mg', 'type': 'DRUG', 'description': 'Subjects will receive fenofibrate 54mg daily.', 'armGroupLabels': ["Intervention 'Fenofibrate 54mg'"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '30305', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Kaiser Permanente of Georgia', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Kendra Manigault, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pharmacy Resident'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}