Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-29 @ 7:55 PM
Study NCT ID:
NCT04714151
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2021-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase III Confirmatory Study of K-877 Extended Release Tablet
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': 'C540740', 'term': '(R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 356}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2021-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2021-01-15', 'studyFirstSubmitQcDate': '2021-01-15', 'lastUpdatePostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy : % change from baseline in fasting serum TG (mg/dL)', 'timeFrame': '4, 8, and 12 week after administration'}], 'secondaryOutcomes': [{'measure': 'Efficacy : % change from baseline in fasting serum Total Cholesterol (mg/dL)', 'timeFrame': '4, 8, and 12 week after administration'}, {'measure': 'Efficacy : % change from baseline in fasting serum LDL-C (mg/dL)', 'timeFrame': '4, 8, and 12 week after administration'}, {'measure': 'Efficacy : % change from baseline in fasting serum HDL-C (mg/dL)', 'timeFrame': '4, 8, and 12 week after administration'}, {'measure': 'Efficacy : % change from baseline in fasting serum non-HDL-C (mg/dL)', 'timeFrame': '4, 8, and 12 week after administration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dyslipidemias']}, 'referencesModule': {'references': [{'pmid': '38616112', 'type': 'RESULT', 'citation': 'Arai H, Yamashita S, Araki E, Yokote K, Tanigawa R, Saito A, Yamasaki S, Suganami H, Ishibashi S. Efficacy and Safety of Pemafibrate Extended-Release Tablet: a Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group Comparison Trial. J Atheroscler Thromb. 2024 Nov 1;31(11):1517-1538. doi: 10.5551/jat.64677. Epub 2024 Apr 13.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the efficacy and safety of K-877 Extended Release (ER) 0.2 mg/day or 0.4 mg/day (once daily) for 12 weeks in dyslipidemia, using K-877 Immediate Release (IR) 0.2 mg/day (twice daily) as a control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with dyslipidemia had to be age 20 years or older at written informed consent\n2. Patients who have received dietary or exercise guidance from 12 weeks or more prior to Screening\n3. Patients with the fasting serum TG \\>= 200 mg/dL twice consecutively at Screening\n\nExclusion Criteria:\n\n1. Patients with a fasting serum TG \\> 1000 mg/dL at Screening\n2. Patients who require administration of prohibited drugs during the clinical trial period after written informed consent\n3. Patients with uncontrolled thyroid disease\n4. Patients with type 1 diabetes and uncontrolled diabetes \\[HbA1c(NGSP) \\>= 8.0 % at Screening\\]\n5. Patients with uncontrolled hypertension (SBP \\>= 160 mmHg or DBP \\>= 100 mmHg)\n6. Patients with an AST or ALT three times the upper limit at Screening\n7. Patients with an CK five times the upper limit at Screening\n8. Patients with cirrhosis or those with biliary obstruction\n9. Patients with acute myocardial infarction within 3 months before obtaining informed consent\n10. Patients with heart failure class III or higher according to NYHA cardiac function classification\n11. Patients with malignant tumor or those who are judged to have a high risk of recurrence\n12. Patients with a history of serious drug allergies (anaphylactic shock, etc.)\n13. Pregnant women, lactating women, women planning to become pregnant or lactating during the study period, or pregnant women who do not use specific contraceptive methods\n14. Patients who have collected 400 mL or more of whole blood within 16 weeks, or 200 mL or more of whole blood within 4 weeks, or blood samples (plasma and platelet components) within 2 weeks before Screening\n15. Patients who have received K-877 (pemafibrate)\n16. Patients who participate in other clinical trials at the time of written informed consent and who received medication or who have received clinical trials other than placebo for less than 16 weeks\n17. Patients who have been determined inappropriate by the investigator, etc'}, 'identificationModule': {'nctId': 'NCT04714151', 'briefTitle': 'A Phase III Confirmatory Study of K-877 Extended Release Tablet', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kowa Company, Ltd.'}, 'officialTitle': 'A Phase III Confirmatory Study of K-877 Extended Release Tablet-A Multicenter, Active Controlled, Randomized, Double Blind, Parallel Group Controlled Trial in Patients With Dyslipidemia With High TG-', 'orgStudyIdInfo': {'id': 'K-877-ER-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'description': 'K-877 ER 0.2 mg/day (once daily)', 'interventionNames': ['Drug: K-877 ER 0.2 mg/day (once daily)']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'description': 'K-877 ER 0.4 mg/day (once daily)', 'interventionNames': ['Drug: K-877 ER 0.4 mg/day (once daily)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control A', 'description': 'K-877 IR 0.2 mg/day (twice daily)', 'interventionNames': ['Drug: K-877 IR 0.2 mg/day (twice daily)']}], 'interventions': [{'name': 'K-877 ER 0.2 mg/day (once daily)', 'type': 'DRUG', 'otherNames': ['Pemafibrate ER 0.2 mg/day (once daily)'], 'description': 'K-877 ER 0.2 mg tablet', 'armGroupLabels': ['Treatment A']}, {'name': 'K-877 ER 0.4 mg/day (once daily)', 'type': 'DRUG', 'otherNames': ['Pemafibrate ER 0.4 mg/day (once daily)'], 'description': 'K-877 ER 0.4 mg tablet', 'armGroupLabels': ['Treatment B']}, {'name': 'K-877 IR 0.2 mg/day (twice daily)', 'type': 'DRUG', 'otherNames': ['Pemafibrate IR 0.2 mg/day (twice daily)'], 'description': 'K-877 IR 0.1 mg tablet', 'armGroupLabels': ['Control A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Institute Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Medical Corporation Heishinkai OCROM Clinic', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Dojinkinenkai Meiwa Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Fukuwa Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Ikebukuro Metropolitan Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Medical Corp. Seikoukai New Medical Research System Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Medical Corporation Asbo Tokyo Asbo Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Medical Corporation Chiseikai Tokyo Center Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Medical Corporation Heishinkai ToCROM Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Medical Corporation Yuhokai Miho Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo-Eki Center-building Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kowa Company, Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}