Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-27 @ 9:21 PM
Study NCT ID:
NCT06293261
Status:
COMPLETED
Last Update Posted:
2025-01-22
First Post:
2024-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter, Prospective, Non-interventional, Observational Study to Confirm the Long-term Efficacy and Safety of Rosuampin Tab. in Patients With Hypertension and Hypercholesterolemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5047}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2024-02-28', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurence rate of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events)', 'timeFrame': 'Baseline, 12 Months'}], 'secondaryOutcomes': [{'measure': 'Change from baseline to 6/12 months in SBP and DBP', 'timeFrame': 'Baseline, 6, 12 Months'}, {'measure': 'Percent change from baseline to 6/12 months in Lipid Profile (TC, LDL-C, TG, HDL-C)', 'timeFrame': 'Baseline, 6, 12 Months'}, {'measure': 'Change from baseline to 6/12 months in hs-CRP', 'timeFrame': 'Baseline, 6, 12 Months'}, {'measure': 'Change from baseline to 6/12 months in Diabetes indicator (Fasting Blood Glucose)', 'timeFrame': 'Baseline, 6, 12 Months'}, {'measure': 'Change from baseline to 6/12 months in Diabetes indicator ( HbA1c)', 'timeFrame': 'Baseline, 6, 12 Months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['long-term efficacy and safety of Rusuampin Tab'], 'conditions': ['Hypertension', 'Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'This study is to confirm the long-term efficacy and safety of Rosuampin Tab. in patients with hypertension and hypercholesterolemia', 'detailedDescription': "All treatments, such as drug administration and clinical laboratory tests performed after Rosuampine administration, are performed according to the investigator's medical judgment, and information to be confirmed in this observational study is collected for up to 12 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with hypertension and hypercholesterolemia who are receiving Rosuampin medication or need Rosuampin medication according to the medical judgment of the investigator', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged ≥ 19 years\n2. Patients with hypertension and hypercholesterolemia who are receiving Rosuampin medication or need Rosuampin medication according to the medical judgment of the investigator\n3. Written informed consent\n\nExclusion Criteria:\n\n1. Patients with hypersensitivity to components of this drug or other dihydropyridine drugs\n2. A woman who is pregnant or likely to be pregnant, a woman of childbearing age who does not use appropriate contraception and a nursing woman\n3. a patient with severe liver failure\n4. Patients with active liver disease who include continuous serum transaminase elevation of unknown cause or serum transaminase elevation over three times the upper limit of normal\n5. a patient with severe aortic valvular stenosis\n6. a myopathy patient\n7. a cyclosporine co-administered patient\n8. a patient with severe renal failure (CLcr, creatinine clearance \\<30 mL/min)'}, 'identificationModule': {'nctId': 'NCT06293261', 'briefTitle': 'Multicenter, Prospective, Non-interventional, Observational Study to Confirm the Long-term Efficacy and Safety of Rosuampin Tab. in Patients With Hypertension and Hypercholesterolemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yuhan Corporation'}, 'officialTitle': 'Multicenter, Prospective, Non-interventional, Observational Study to Confirm the Long-term Efficacy and Safety of Rosuampin Tab. in Patients With Hypertension and Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'YMC043'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rosuampin 5/5mg (Rosuvastatin 5mg + Amlodipine 5mg)', 'interventionNames': ['Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg']}, {'label': 'Rosuampin 10/5mg (Rosuvastatin 10mg + Amlodipine 5mg)', 'interventionNames': ['Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg']}, {'label': 'Rosuampin 20/5mg (Rosuvastatin 20mg + Amlodipine 5mg)', 'interventionNames': ['Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg']}, {'label': 'Rosuampin 10/10mg (Rosuvastatin', 'interventionNames': ['Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg']}], 'interventions': [{'name': 'Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg', 'type': 'DRUG', 'description': 'Experimental only, not included active and placebo comparator', 'armGroupLabels': ['Rosuampin 10/10mg (Rosuvastatin', 'Rosuampin 10/5mg (Rosuvastatin 10mg + Amlodipine 5mg)', 'Rosuampin 20/5mg (Rosuvastatin 20mg + Amlodipine 5mg)', 'Rosuampin 5/5mg (Rosuvastatin 5mg + Amlodipine 5mg)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anyang-si', 'country': 'South Korea', 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 37.3925, 'lon': 126.92694}}, {'zip': '49201', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Dong-A University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Changwon', 'country': 'South Korea', 'facility': 'Changwon Fatima Hospital', 'geoPoint': {'lat': 35.22806, 'lon': 128.68111}}, {'city': 'Changwon', 'country': 'South Korea', 'facility': 'Gyeongsang National University Changwon Hospital', 'geoPoint': {'lat': 35.22806, 'lon': 128.68111}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Daegu Catholic University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Yeungnam University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Daejeon Eulji Medical Center Eulji University', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Goyang-si', 'country': 'South Korea', 'facility': 'Myungji Hospital', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chosun University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Bundang Jesaeng General Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Cha University Bundang Medical Center', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Hallym University Dongtan Sacred Heart Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'National Health Insurance Service Ilsan Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeongsang', 'country': 'South Korea', 'facility': 'Samsung Changwon Hospital', 'geoPoint': {'lat': 35.3164, 'lon': 126.93455}}, {'city': 'Iksan', 'country': 'South Korea', 'facility': 'Wonkwang University Hospital', 'geoPoint': {'lat': 35.94389, 'lon': 126.95444}}, {'city': 'Ilsan', 'country': 'South Korea', 'facility': 'Dongguk University Ilsan Hospital', 'geoPoint': {'lat': 35.5, 'lon': 129.43333}}, {'city': 'Ilsan', 'country': 'South Korea', 'facility': 'Inje University Ilsan Paik Hospital', 'geoPoint': {'lat': 35.5, 'lon': 129.43333}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': "Kwandong University International St.Mary'S Hospital", 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Jungbuk', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Hospital Cheonan', 'geoPoint': {'lat': 35.55292, 'lon': 127.49042}}, {'city': 'Jungnam', 'country': 'South Korea', 'facility': 'Dankook University Hospital', 'geoPoint': {'lat': 36.27333, 'lon': 128.02522}}, {'city': 'Kwangju', 'country': 'South Korea', 'facility': 'Kwangju Veterance Hospital', 'geoPoint': {'lat': 36.9122, 'lon': 127.1279}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'zip': '06273', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans University Mokdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans University Seoul Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hallym University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangdong Sacred Heart 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': 'Kyung Hee University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'National Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}, {'city': 'Wŏnju', 'country': 'South Korea', 'facility': 'Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}], 'overallOfficials': [{'name': 'Moohyun Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dong-A University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuhan Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}