Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 6:08 AM
Study NCT ID:
NCT03874260
Status:
UNKNOWN
Last Update Posted:
2019-03-15
First Post:
2019-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cinical Trial to Explore the Efficacy of Statin/Choline Fenofibrate Combination Therapy vs Statin Monotherapy in Patients With Inadequately Controlled TG Despite Receiving Statin Monotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-13', 'studyFirstSubmitDate': '2019-03-12', 'studyFirstSubmitQcDate': '2019-03-12', 'lastUpdatePostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of change for Triglyceride based on baseline', 'timeFrame': '8week'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dyslipidemias']}, 'referencesModule': {'references': [{'pmid': '34518033', 'type': 'DERIVED', 'citation': 'Park MS, Youn JC, Kim EJ, Han KH, Lee SH, Kim SH, Kim BJ, Kwon SU, Ryu KH. Efficacy and Safety of Fenofibrate-Statin Combination Therapy in Patients With Inadequately Controlled Triglyceride Levels Despite Previous Statin Monotherapy: A Multicenter, Randomized, Double-blind, Phase IV Study. Clin Ther. 2021 Oct;43(10):1735-1747. doi: 10.1016/j.clinthera.2021.08.005. Epub 2021 Sep 10.'}]}, 'descriptionModule': {'briefSummary': 'A Multi-center, Randomized, Double-blind, Parallel Phase Ⅳ Study to Explore the Efficacy of Statin/Choline Fenofibrate Combination Therapy vs Statin Monotherapy in Patients With Inadequately Controlled TG Despite Receiving Statin Monotherapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* both male and female who are over 19-year-old\n* 200mg/dl≤TG\\<500mg/dl\n* Desired value of LDL-c\n\n 1. very high risk \\< 70\n 2. high risk \\< 100\n 3. moderate risk \\<130\n 4. low risk \\< 160\n\nExclusion Criteria:\n\n* patient who is going to have an operation during this study\n* patient who has allergy or hypersensitivity of fenofibrate\n* patient who has abnormal ECG'}, 'identificationModule': {'nctId': 'NCT03874260', 'briefTitle': 'Cinical Trial to Explore the Efficacy of Statin/Choline Fenofibrate Combination Therapy vs Statin Monotherapy in Patients With Inadequately Controlled TG Despite Receiving Statin Monotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewon Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Parallel Phase Ⅳ Study to Explore the Efficacy of Statin/Choline Fenofibrate Combination Therapy vs Statin Monotherapy in Patients With Inadequately Controlled TG Despite Receiving Statin Monotherapy', 'orgStudyIdInfo': {'id': 'DWTF-401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'statin / fenofibrate', 'description': 'stable statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg)+ choline fenofibrate 178.8mg / once a day, P.O', 'interventionNames': ['Drug: Fenofibrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'statin / fenofibrate placebo', 'description': 'stable statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg) + choline fenofibrate placebo / once a day, P.O', 'interventionNames': ['Drug: Fenofibrate']}], 'interventions': [{'name': 'Fenofibrate', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg) + choline fenofibrate vs statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg) + choline fenofibrate placebo / once a day, P.O', 'armGroupLabels': ['statin / fenofibrate', 'statin / fenofibrate placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hwaseong-si', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'KYUHYEONG YU', 'role': 'CONTACT'}], 'facility': 'Hallym University Dongtan Sacred Heart Hospital', 'geoPoint': {'lat': 37.20682, 'lon': 126.8169}}], 'centralContacts': [{'name': 'Jinmin Lee', 'role': 'CONTACT', 'email': 'jmlee@daewonpharm.com', 'phone': '82-2-2204-7001'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewon Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}