Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-28 @ 3:38 AM
Study NCT ID:
NCT01914432
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2013-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of YH16410 Versus Rosuvastatin and Telmisartan Monotherapies in Patients With Hypertension and Hyperlipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D000077333', 'term': 'Telmisartan'}], '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'}, {'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-07', 'studyFirstSubmitDate': '2013-07-30', 'studyFirstSubmitQcDate': '2013-07-30', 'lastUpdatePostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Diastolic Blood Pressure, Change in LDL Cholesterol', 'timeFrame': 'Change from Baseline at 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hyperlipidemia', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '29673890', 'type': 'DERIVED', 'citation': 'Oh GC, Han JK, Han KH, Hyon MS, Doh JH, Kim MH, Jeong JO, Bae JH, Kim SH, Yoo BS, Baek SH, Rhee MY, Ihm SH, Sung JH, Choi YJ, Kim SJ, Hong KS, Lee BK, Cho J, Shin ES, Rhew JY, Kim H, Kim HS. Efficacy and Safety of Fixed-dose Combination Therapy With Telmisartan and Rosuvastatin in Korean Patients With Hypertension and Dyslipidemia: TELSTA-YU (TELmisartan-rosuvaSTAtin from YUhan), a Multicenter, Randomized, 4-arm, Double-blind, Placebo-controlled, Phase III Study. Clin Ther. 2018 May;40(5):676-691.e1. doi: 10.1016/j.clinthera.2018.03.010. Epub 2018 Apr 17.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate efficacy and safety of YH16410 versus rosuvastatin and telmisartan monotherapies in patients with hypertension and hyperlipidemia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed Informed Consent\n* Men and women ≥ 19 years of age\n* Subject who has one of 3 conditions classified by Cardiovascular Risk Factors, 10-Year Risk, Blood Pressure, LDL-C, TG, Coronary Artery Disease and Equivalent\n\nExclusion Criteria:\n\n* Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study.\n* Other exclusions applied'}, 'identificationModule': {'nctId': 'NCT01914432', 'briefTitle': 'Efficacy and Safety Study of YH16410 Versus Rosuvastatin and Telmisartan Monotherapies in Patients With Hypertension and Hyperlipidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yuhan Corporation'}, 'officialTitle': 'A Double-blind, Randomized, Multi-center Phase III Clinical Trial to Investigate the Safety and Efficacy Between YH16410 Versus Rosuvastatin and Telmisartan Monotherapies in Patients With Hypertension and Hyperlipidemia', 'orgStudyIdInfo': {'id': 'YH16410-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'YH16410', 'description': 'PO, Once Daily, 8 weeks', 'interventionNames': ['Drug: YH16410', 'Drug: Rosuvastatin placebo', 'Drug: Telmisartan placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rosuvastatin', 'description': 'PO, Once Daily, 8 weeks', 'interventionNames': ['Drug: Rosuvastatin', 'Drug: YH16410 placebo', 'Drug: Telmisartan placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Telmisartan', 'description': 'PO, Once Daily, 8 weeks', 'interventionNames': ['Drug: Telmisartan', 'Drug: YH16410 placebo', 'Drug: Rosuvastatin placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'PO, Once Daily, 8 weeks', 'interventionNames': ['Drug: YH16410 placebo', 'Drug: Rosuvastatin placebo', 'Drug: Telmisartan placebo']}], 'interventions': [{'name': 'YH16410', 'type': 'DRUG', 'armGroupLabels': ['YH16410']}, {'name': 'Rosuvastatin', 'type': 'DRUG', 'armGroupLabels': ['Rosuvastatin']}, {'name': 'Telmisartan', 'type': 'DRUG', 'armGroupLabels': ['Telmisartan']}, {'name': 'YH16410 placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo', 'Rosuvastatin', 'Telmisartan']}, {'name': 'Rosuvastatin placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo', 'Telmisartan', 'YH16410']}, {'name': 'Telmisartan placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo', 'Rosuvastatin', 'YH16410']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Su Youn Nam, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yuhan Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuhan Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}