protocolSection identificationModule nctId: NCT06293261, orgStudyIdInfo id: YMC043, briefTitle: Multicenter, Prospective, Non-interventional, Observational Study to Confirm the Long-term Efficacy and Safety of Rosuampin Tab. in Patients With Hypertension and Hypercholesterolemia, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2020-06-27, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Yuhan Corporation, class: INDUSTRY, descriptionModule briefSummary: This study is to confirm the long-term efficacy and safety of Rosuampin Tab. in patients with hypertension and hypercholesterolemia, conditionsModule conditions: Hypertension, conditions: Hypercholesterolemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 5047, type: ACTUAL, armsInterventionsModule interventions name: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg, outcomesModule primaryOutcomes measure: Occurence rate of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events), secondaryOutcomes measure: Change from baseline to 6/12 months in SBP and DBP, secondaryOutcomes measure: Percent change from baseline to 6/12 months in Lipid Profile (TC, LDL-C, TG, HDL-C), secondaryOutcomes measure: Change from baseline to 6/12 months in hs-CRP, secondaryOutcomes measure: Change from baseline to 6/12 months in Diabetes indicator (Fasting Blood Glucose), secondaryOutcomes measure: Change from baseline to 6/12 months in Diabetes indicator ( HbA1c), eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hallym University Sacred Heart Hospital, city: Anyang-si, country: Korea, Republic of, geoPoint lat: 37.3925, lon: 126.92694, locations facility: Dong-A University Hospital, city: Busan, zip: 49201, country: Korea, Republic of, geoPoint lat: 35.10278, lon: 129.04028, locations facility: Changwon Fatima Hospital, city: Changwon, country: Korea, Republic of, geoPoint lat: 35.22806, lon: 128.68111, locations facility: Gyeongsang National University Changwon Hospital, city: Changwon, country: Korea, Republic of, geoPoint lat: 35.22806, lon: 128.68111, locations facility: Soon Chun Hyang University Hospital Cheonan, city: Chungbuk, country: Korea, Republic of, geoPoint lat: 35.55292, lon: 127.49042, locations facility: Dankook University Hospital, city: Chungnam, country: Korea, Republic of, geoPoint lat: 36.27333, lon: 128.02522, locations facility: Daegu Catholic University Medical Center, city: Daegu, country: Korea, Republic of, geoPoint lat: 35.87028, lon: 128.59111, locations facility: Keimyung University Dongsan Medical Center, city: Daegu, country: Korea, Republic of, geoPoint lat: 35.87028, lon: 128.59111, locations facility: Yeungnam University Medical Center, city: Daegu, country: Korea, Republic of, geoPoint lat: 35.87028, lon: 128.59111, locations facility: Daejeon Eulji Medical Center Eulji University, city: Daejeon, country: Korea, Republic of, geoPoint lat: 36.32139, lon: 127.41972, locations facility: Myungji Hospital, city: Goyang-si, country: Korea, Republic of, geoPoint lat: 37.65639, lon: 126.835, locations facility: Chonnam National University Hospital, city: Gwangju, country: Korea, Republic of, geoPoint lat: 35.15472, lon: 126.91556, locations facility: Chosun University Hospital, city: Gwangju, country: Korea, Republic of, geoPoint lat: 35.15472, lon: 126.91556, locations facility: Bundang Jesaeng General Hospital, city: Gyeonggi-do, country: Korea, Republic of, geoPoint lat: 37.58944, lon: 126.76917, locations facility: Cha University Bundang Medical Center, city: Gyeonggi-do, country: Korea, Republic of, geoPoint lat: 37.58944, lon: 126.76917, locations facility: Hallym University Dongtan Sacred Heart Hospital, city: Gyeonggi-do, country: Korea, Republic of, geoPoint lat: 37.58944, lon: 126.76917, locations facility: Korea University Ansan Hospital, city: Gyeonggi-do, country: Korea, Republic of, geoPoint lat: 37.58944, lon: 126.76917, locations facility: National Health Insurance Service Ilsan Hospital, city: Gyeonggi-do, country: Korea, Republic of, geoPoint lat: 37.58944, lon: 126.76917, locations facility: Samsung Changwon Hospital, city: Gyeongsang, country: Korea, Republic of, geoPoint lat: 35.3164, lon: 126.93455, locations facility: Wonkwang University Hospital, city: Iksan, country: Korea, Republic of, geoPoint lat: 35.94389, lon: 126.95444, locations facility: Dongguk University Ilsan Hospital, city: Ilsan, country: Korea, Republic of, geoPoint lat: 35.5, lon: 129.43333, locations facility: Inje University Ilsan Paik Hospital, city: Ilsan, country: Korea, Republic of, geoPoint lat: 35.5, lon: 129.43333, locations facility: Inha University Hospital, city: Incheon, country: Korea, Republic of, geoPoint lat: 37.45646, lon: 126.70515, locations facility: Kwandong University International St.Mary'S Hospital, city: Incheon, country: Korea, Republic of, geoPoint lat: 37.45646, lon: 126.70515, locations facility: Kwangju Veterance Hospital, city: Kwangju, country: Korea, Republic of, geoPoint lat: 36.9122, lon: 127.1279, locations facility: Pusan National University Hospital, city: Pusan, country: Korea, Republic of, geoPoint lat: 35.10278, lon: 129.04028, locations facility: Pusan National University Yangsan Hospital, city: Pusan, country: Korea, Republic of, geoPoint lat: 35.10278, lon: 129.04028, locations facility: Gangnam Severance Hospital, city: Seoul, zip: 06273, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Ewha Womans University Mokdong Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Ewha Womans University Seoul Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Hallym University Medical Center, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Kangdong Sacred Heart Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Korea University Anam Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Korea University Guro Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Kyung Hee University Medical Center, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: National Medical Center, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Samsung Medical Center, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Ulsan University, city: Ulsan, country: Korea, Republic of, geoPoint lat: 35.53722, lon: 129.31667, locations facility: Wonju Severance Christian Hospital, city: Wŏnju, country: Korea, Republic of, geoPoint lat: 37.35139, lon: 127.94528, hasResults: False