Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-02-25 @ 10:03 PM
Study NCT ID:
NCT02670434
Status:
WITHDRAWN
Last Update Posted:
2021-05-10
First Post:
2016-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Comparison Study of NK-104-CR (Controled Release) in Patients 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C108475', 'term': 'pitavastatin'}]}}, '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'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-06', 'studyFirstSubmitDate': '2016-01-28', 'studyFirstSubmitQcDate': '2016-01-28', 'lastUpdatePostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change in LDL-C from baseline', 'timeFrame': '12 Weeks'}], 'secondaryOutcomes': [{'measure': 'The percent change from baseline in fasting serum total cholesterol (TC )', 'timeFrame': '12 Weeks'}]}, 'conditionsModule': {'conditions': ['Hyperlipidemia', 'Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of NK-104-CR with Placebo and Livalo® on the reduction of LDL-C and to evaluate the safety of NK-104-CR in patients with primary hyperlipidemia or mixed dyslipidemia'}, '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 who are ≥18 and ≤80 years of age at the time of consent;\n* Fasting plasma LDL-C ≥160 mg/dL and ≤250 mg/dL and TG values of ≤300 mg/dL\n* Patients who are naïve to statin or who are able to safely discontinue the use of all lipid-lowering agents for 6 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 \\>8%'}, 'identificationModule': {'nctId': 'NCT02670434', 'briefTitle': 'Safety and Efficacy Comparison Study of NK-104-CR (Controled Release) in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kowa Research Institute, Inc.'}, 'orgStudyIdInfo': {'id': 'NK-104-CR-3.01US'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NK-104-CR', 'description': 'Controlled release NK-104', 'interventionNames': ['Drug: NK-104-CR']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Livalo Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Livalo® Immediate Release IR', 'description': 'Immediate Release Livalo®', 'interventionNames': ['Drug: Livalo']}], 'interventions': [{'name': 'NK-104-CR', 'type': 'DRUG', 'description': 'NK-104-CR 8 mg daily for 52 weeks', 'armGroupLabels': ['NK-104-CR']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo daily for 12 weeks', 'armGroupLabels': ['Placebo']}, {'name': 'Livalo', 'type': 'DRUG', 'description': 'Livalo® IR daily from week 12 to week 52', 'armGroupLabels': ['Livalo® Immediate Release IR']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'city': 'Chino', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.01223, 'lon': -117.68894}}, {'city': 'Lincoln', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.89156, 'lon': -121.29301}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'city': 'North Hollywood', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.17223, 'lon': -118.37897}}, {'city': 'Thousand Oaks', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.17056, 'lon': -118.83759}}, {'city': 'Vista', 'state': 'California', 'country': 'United 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