Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-03-04 @ 11:10 PM
Study NCT ID:
NCT03103256
Status:
COMPLETED
Last Update Posted:
2018-09-07
First Post:
2017-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Efficacy and Safety of YHP1701
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'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': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-06', 'studyFirstSubmitDate': '2017-03-22', 'studyFirstSubmitQcDate': '2017-03-30', 'lastUpdatePostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change of LDL-Cholesterol', 'timeFrame': '0, 8 weeks', 'description': 'LDL-Cholesterol'}, {'measure': 'Change of mean seated Systolic Blood Pressure', 'timeFrame': '0, 8 weeks', 'description': 'Blood Pressure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension and Hyperlipidemia']}, 'referencesModule': {'references': [{'pmid': '32003938', 'type': 'DERIVED', 'citation': 'Kim W, Chang K, Cho EJ, Ahn JC, Yu CW, Cho KI, Kim YJ, Kang DH, Kim SY, Lee SH, Kim U, Kim SJ, Ahn YK, Lee CH, Shin JH, Kim M, Park CG. A randomized, double-blind clinical trial to evaluate the efficacy and safety of a fixed-dose combination of amlodipine/rosuvastatin in patients with dyslipidemia and hypertension. J Clin Hypertens (Greenwich). 2020 Feb;22(2):261-269. doi: 10.1111/jch.13774. Epub 2020 Jan 31.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine superiority of YHP1701 comparing to each monotherapy in patient with hypertension and primary hypercholesterolemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both man and woman who is over 19 years old\n* Patient with dyslipidemia and hypertension\n\nExclusion Criteria:\n\n* sSBP difference is ≥20 mmHg or sDBP difference is ≥10 mmHg\n* A history of cardiovascular disease\n* Rhabdomyolysis, myopathy\n* Hypertension or hypercholesterolemia due to secondary causes\n* Uncontrolled diabetes\n* Evidence of hepatic or renal disease'}, 'identificationModule': {'nctId': 'NCT03103256', 'briefTitle': 'Clinical Trial to Evaluate the Efficacy and Safety of YHP1701', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yuhan Corporation'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Parallel-group Phase III Clinical Trial to Evaluate the Efficacy and Safety of YHP1701 Fixed Dose Combination in Patients With Dyslipidemia and Hypertension', 'orgStudyIdInfo': {'id': 'YHP1701-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'YHP1701', 'description': 'PO, Once daily (QD), 8 weeks', 'interventionNames': ['Drug: YHP1701']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'YHR1703', 'description': 'PO, Once daily (QD), 8 weeks', 'interventionNames': ['Drug: YHR1703']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'YHR1704', 'description': 'PO, Once daily (QD), 8 weeks', 'interventionNames': ['Drug: YHR1704']}], 'interventions': [{'name': 'YHP1701', 'type': 'DRUG', 'description': 'PO, Once daily (QD), 8 weeks', 'armGroupLabels': ['YHP1701']}, {'name': 'YHR1703', 'type': 'DRUG', 'description': 'PO, Once daily (QD), 8 weeks', 'armGroupLabels': ['YHR1703']}, {'name': 'YHR1704', 'type': 'DRUG', 'description': 'PO, Once daily (QD), 8 weeks', 'armGroupLabels': ['YHR1704']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Andrew Lee', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yuhan Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuhan Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}