Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT03583905
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2018-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Efficacy and Safety of CKD-333 Tablet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-22', 'studyFirstSubmitDate': '2018-05-24', 'studyFirstSubmitQcDate': '2018-07-10', 'lastUpdatePostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change rate from baseline in LDL-C', 'timeFrame': '8 weeks after drug administrations', 'description': 'Compare experimental group 1 with placebo group 1'}, {'measure': 'Change from baseline in MSSBP', 'timeFrame': '8 weeks after drug administrations', 'description': 'Compare experimental group 1 with placebo group 2'}], 'secondaryOutcomes': [{'measure': 'Change rate from baseline in LDL-C', 'timeFrame': '4 weeks after drug administrations', 'description': 'Compare experimental group 1 with placebo group 1'}, {'measure': 'Change from baseline in LDL-C', 'timeFrame': '4, 8 weeks after drug administrations', 'description': 'Compare experimental group 1 with placebo group 1'}, {'measure': 'Attainment of LDL-C treatment goal as defined by NCEP ATP Ⅲ Guideline', 'timeFrame': '4, 8 weeks after drug administrations', 'description': 'Compare experimental group 1 with placebo group 1'}, {'measure': 'Change from baseline in MSSBP(mmHg)', 'timeFrame': '4 weeks after drug administrations', 'description': 'Compare experimental group 1 with placebo group 2'}, {'measure': 'Change from baseline in MSDBP', 'timeFrame': '4, 8 weeks after drug administrations', 'description': 'Compare experimental group 1 with placebo group 2'}, {'measure': 'Attainment of normal blood pressure as defined by JNC Ⅶ', 'timeFrame': '4, 8 weeks after drug administrations', 'description': 'Compare experimental group 1 with placebo group 2'}, {'measure': 'Change from baseline in TC', 'timeFrame': '4, 8 weeks after drug administrations', 'description': 'Compare experimental group 1 with placebo group 1'}, {'measure': 'Change from baseline in TG', 'timeFrame': '4, 8 weeks after drug administrations', 'description': 'Compare experimental group 1 with placebo group 1'}, {'measure': 'Change from baseline in HDL-C', 'timeFrame': '4, 8 weeks after drug administrations', 'description': 'Compare experimental group 1 with placebo group 1'}, {'measure': 'change rate from baseline in TC', 'timeFrame': '4, 8 weeks after drug administrations', 'description': 'Compare experimental group 1 with placebo group 1'}, {'measure': 'change rate from baseline in TG', 'timeFrame': '4, 8 weeks after drug administrations', 'description': 'Compare experimental group 1 with placebo group 1'}, {'measure': 'change rate from baseline in HDL-C', 'timeFrame': '4, 8 weeks after drug administrations', 'description': 'Compare experimental group 1 with placebo group 1'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertensive Patients With Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'To Evaluate the Efficacy and Safety of CKD-333', 'detailedDescription': 'A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-330 and D086 Combination Therapy in Hypertensive Patients with Dyslipidemia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with a mean sitting systolic blood pressure (MSSBP) ≥ 140 mmHg measured on selected arms after run-in period\n2. Lipid levels measured after run-in period were:\n\n * Group 1: hypertension + dyslipidemia only → fasting LDL-C ≥ 160 mg / dL\n * Group 2: hypertension + dyslipidemia + cardiovascular risk factor more than 1 → fasting LDL-C ≥ 130mg / dL\n * Group 3: hypertension + dyslipidemia + coronary artery disease or equivalent or 10-year risk assessed by Framingham Point Score greater than 20% → fasting LDL-C ≥ 100 mg / dL\n\nExclusion Criteria:\n\n1. Patients whose blood pressures measured at Visit 2 were:\n\n * Patients with MSSBP ≥ 180 mmHg and / or MSDBP ≥ 110 mmHg\n2. Patients who had lipid levels measured at Visit 2\n\n * Patients with fasting LDL-C \\<100 mg / dL or fasting LDL-C\\> 250 mg / dL and / or TG ≥ 500 mg / dL'}, 'identificationModule': {'nctId': 'NCT03583905', 'briefTitle': 'Clinical Trial to Evaluate the Efficacy and Safety of CKD-333 Tablet', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-330 and D086 Combination Therapy in Hypertensive Patients With Dyslipidemia', 'orgStudyIdInfo': {'id': '170HT/DL17007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group 1', 'description': 'Patients assigned to this group are treated with CKD-330, D086', 'interventionNames': ['Drug: CKD-330', 'Drug: D086', 'Drug: Placebo of D723']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group 1', 'description': 'Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the D086)', 'interventionNames': ['Drug: CKD-330', 'Drug: Placebo of D086', 'Drug: Placebo of D723']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group 2', 'description': 'Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the CKD-330)', 'interventionNames': ['Drug: Placebo of CKD-330', 'Drug: D086', 'Drug: D723']}], 'interventions': [{'name': 'CKD-330', 'type': 'DRUG', 'description': 'CKD-330 Tab.', 'armGroupLabels': ['Experimental Group 1', 'Placebo Group 1']}, {'name': 'Placebo of CKD-330', 'type': 'DRUG', 'description': 'Placebo of CKD-330 Tab.', 'armGroupLabels': ['Placebo Group 2']}, {'name': 'D086', 'type': 'DRUG', 'description': 'D086 Tab.', 'armGroupLabels': ['Experimental Group 1', 'Placebo Group 2']}, {'name': 'Placebo of D086', 'type': 'DRUG', 'description': 'Placebo of D086 Tab.', 'armGroupLabels': ['Placebo Group 1']}, {'name': 'D723', 'type': 'DRUG', 'description': 'D723 Tab.', 'armGroupLabels': ['Placebo Group 2']}, {'name': 'Placebo of D723', 'type': 'DRUG', 'description': 'Placebo of D723 Tab.', 'armGroupLabels': ['Experimental Group 1', 'Placebo Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Busan', 'country': 'South Korea', 'facility': 'Dong-A University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon University Gil Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "Catholic University Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hanyang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyunghee University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University Medical Center Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University Medical Center Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Wŏnju', 'country': 'South Korea', 'facility': 'Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}