Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-05-25 @ 7:11 AM
Study NCT ID:
NCT03026933
Status:
COMPLETED
Last Update Posted:
2017-01-20
First Post:
2017-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled
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': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-19', 'studyFirstSubmitDate': '2017-01-16', 'studyFirstSubmitQcDate': '2017-01-19', 'lastUpdatePostDateStruct': {'date': '2017-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation rate of Non HDL-C', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Variation rate of TG', 'timeFrame': '4 weeks, 8 weeks'}, {'measure': 'Variation rate of Non HDL-C', 'timeFrame': '4 weeks'}, {'measure': 'Variation rate of TC', 'timeFrame': '4 weeks, 8 weeks'}, {'measure': 'Variation rate of LDL-C', 'timeFrame': '4 weeks, 8 weeks'}, {'measure': 'Variation rate of VLDL-C', 'timeFrame': '4 weeks, 8 weeks'}, {'measure': 'Variation rate of Apo A-I', 'timeFrame': '4 weeks, 8 weeks'}, {'measure': 'Variation rate of Apo B', 'timeFrame': '4 weeks, 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dyslipidemias']}, 'referencesModule': {'references': [{'pmid': '29223557', 'type': 'DERIVED', 'citation': 'Kim CH, Han KA, Yu J, Lee SH, Jeon HK, Kim SH, Kim SY, Han KH, Won K, Kim DB, Lee KJ, Min K, Byun DW, Lim SW, Ahn CW, Kim S, Hong YJ, Sung J, Hur SH, Hong SJ, Lim HS, Park IB, Kim IJ, Lee H, Kim HS. Efficacy and Safety of Adding Omega-3 Fatty Acids in Statin-treated Patients with Residual Hypertriglyceridemia: ROMANTIC (Rosuvastatin-OMAcor iN residual hyperTrIglyCeridemia), a Randomized, Double-blind, and Placebo-controlled Trial. Clin Ther. 2018 Jan;40(1):83-94. doi: 10.1016/j.clinthera.2017.11.007. Epub 2017 Dec 7.'}]}, 'descriptionModule': {'briefSummary': 'To examine variation rate of Non-HDL with KI1107 comparison Rosuvastatin monotherapy.', 'detailedDescription': 'Study design:\n\nRandomly assigned to two groups(KI1107 or Rosuvastatin monotherpy) after 4 weeks run-in period and prescribed KI1107 or Rosuvastatin for 8 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Screening Visit\n\n * Age: 19-80\n * High risk for cardiovascular disease according to NCEP APT III\n * TG≥130mg/dL and 160mg/dL\\>LDL-C≥100mg/dL for subjects who were not taking statins for 4 weeks\n * 500mg/dL\\>TG≥200mg/dL and LDL-C\\<110mg/dL for subjects who were taking statins for 4 weeks\n* Baseline Visit\n\n * 500mg/dL\\>TG≥200mg/dL\n * LDL-C\\<110mg/dL\n * Reduction of LDL-C dompairng screening visit\n\nExclusion criteria:\n\n* The patient has histories of acute artery disease within 3 months\n* The patient has histories of operation revasculatiation or aneurysm within 6 months\n* The patient has histories of Unexplained myaliga or diagnosed myalgia or rhabdomyolysis\n* The patient has histories of Effectable disease to the procedrue and clinical trial result'}, 'identificationModule': {'nctId': 'NCT03026933', 'acronym': 'ROMANTIC', 'briefTitle': 'Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kuhnil Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multi-center, Randomized, Double Blind, Parallel Phase III Study to Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled', 'orgStudyIdInfo': {'id': '13-OR-8301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'KI1107', 'interventionNames': ['Drug: KI1107 4 Capsules, QD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Rosuvastatin calcium', 'interventionNames': ['Drug: Rosuvastatin Calcium 20 MG, QD']}], 'interventions': [{'name': 'KI1107 4 Capsules, QD', 'type': 'DRUG', 'description': 'KI1107 4 Capsules', 'armGroupLabels': ['Treatment']}, {'name': 'Rosuvastatin Calcium 20 MG, QD', 'type': 'DRUG', 'description': 'Rosuvastatin Calcium 20mg, QD', 'armGroupLabels': ['Control']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuhnil Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}