Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-20 @ 8:11 PM
Study NCT ID:
NCT02799758
Status:
WITHDRAWN
Last Update Posted:
2021-05-10
First Post:
2016-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy & Long-term Safety Comparison Study of NK-104-CR & Livalo® IR With Primary Hyperlipidemia or Mixed Dyslipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-06', 'studyFirstSubmitDate': '2016-06-10', 'studyFirstSubmitQcDate': '2016-06-10', 'lastUpdatePostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change in Low-density lipoprotein cholesterol (LDL-C)', 'timeFrame': 'Baseline to Week 12 endpoint'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hyperlipidemia', 'Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the superior efficacy of NK-104-CR 8 mg daily compared to Livalo® IR 4 mg daily on fasting serum low-density lipoprotein cholesterol (LDL-C) reduction and to evaluate the comparative safety of NK-104-CR 8 mg daily to Livalo® IR 4 mg daily after long-term treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients with primary hyperlipidemia or mixed dyslipidemia\n* Patients for whom lipid-lowering therapy is indicated according to NCEP ATPIII\n* Patients who are naïve to statin or who are able to safely discontinue the use of all lipid-lowering agents for 4 weeks before randomization and throughout study participation\n\nExclusion Criteria:\n\n* Homozygous familial hypercholesterolemia;\n* Any conditions which may cause secondary dyslipidemia.\n* Newly diagnosed or poorly controlled diabetes mellitus as defined by HbA1c \\>9%'}, 'identificationModule': {'nctId': 'NCT02799758', 'briefTitle': 'Efficacy & Long-term Safety Comparison Study of NK-104-CR & Livalo® IR With Primary Hyperlipidemia or Mixed Dyslipidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kowa Research Institute, Inc.'}, 'orgStudyIdInfo': {'id': 'NK-104-CR-3.02US'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NK-104-CR', 'description': 'NK-104-CR 8 mg tablet and Placebo (for Livalo® IR 4 mg tablet) orally once daily for 52 weeks.', 'interventionNames': ['Drug: NK-104-CR', 'Drug: Placebo (for Livalo® IR)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Livalo® IR', 'description': 'Livalo® IR 4 mg tablet and Placebo (for NK-104-CR 8 mg tablet) orally once daily for 52 weeks.', 'interventionNames': ['Drug: Livalo® IR', 'Drug: Placebo (for NK-104-CR)']}], 'interventions': [{'name': 'NK-104-CR', 'type': 'DRUG', 'description': 'NK-104-CR 8 mg for 52 weeks', 'armGroupLabels': ['NK-104-CR']}, {'name': 'Livalo® IR', 'type': 'DRUG', 'description': 'Livalo® IR 4 mg daily for 52 weeks', 'armGroupLabels': ['Livalo® IR']}, {'name': 'Placebo (for NK-104-CR)', 'type': 'DRUG', 'description': 'NK-104-CR 8 mg placebo for 52 weeks', 'armGroupLabels': ['Livalo® IR']}, {'name': 'Placebo (for 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