Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT03860220
Status:
UNKNOWN
Last Update Posted:
2019-03-01
First Post:
2019-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C487936', 'term': 'amlodipine, atorvastatin drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 304}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-28', 'studyFirstSubmitDate': '2019-01-14', 'studyFirstSubmitQcDate': '2019-02-28', 'lastUpdatePostDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent changes in mean sitting systolic blood pressure (MSSBP)', 'timeFrame': '8 weeks', 'description': 'Percent changes in MSSBP from baseline after 8 weeks of treatment'}, {'measure': 'Percent changes in LDL-C', 'timeFrame': '8 weeks', 'description': 'Percent changes in LDL-C from baseline after 8 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Percent changes in LDL-C', 'timeFrame': '4 weeks', 'description': 'Percent changes in LDL-C from baseline after 4 weeks of treatment'}, {'measure': 'Percent changes in TC', 'timeFrame': '4, 8weeks', 'description': 'Percent changes in TC from baseline after 4 and 8 weeks of treatment'}, {'measure': 'Percent changes in TG', 'timeFrame': '4, 8weeks', 'description': 'Percent changes in TG from baseline after 4 and 8 weeks of treatment'}, {'measure': 'Percent changes in HDL-C', 'timeFrame': '4, 8weeks', 'description': 'Percent changes in HDL-C from baseline after 4 and 8 weeks of treatment'}, {'measure': 'Percent changes in Non-HDL-C', 'timeFrame': '4, 8weeks', 'description': 'Percent changes in Non-HDL-C from baseline after 4 and 8 weeks of treatement'}, {'measure': 'Percent changes in Apo B', 'timeFrame': '4, 8weeks', 'description': 'Percent changes in Apo B from baseline after 4 and 8 weeks of treatment'}, {'measure': 'Percent changes in Apo A-I', 'timeFrame': '4, 8weeks', 'description': 'Percent changes in Apo A-I from baseline after 4 and 8 weeks of treatment'}, {'measure': 'Percent changes in LDL-C/HDL-C ratio', 'timeFrame': '4, 8weeks', 'description': 'Percent changes in LDL-C/HDL-C from baseline after 4 and 8 weeks of treatement'}, {'measure': 'Percent changes in Apo B/Apo A-I ratio', 'timeFrame': '4, 8weeks', 'description': 'Percent changes in Apo B/Apo A-I from baseline after 4 and 8 weeks of treatment'}, {'measure': 'Percent changes in hs-CRP', 'timeFrame': '4, 8weeks', 'description': 'Percent changes in hs-CRP from baseline after 4 and 8 weeks of treatment'}, {'measure': 'The percentage of patients achieving treatment goal for blood pressure and LDL-C', 'timeFrame': '8 weeks', 'description': 'The percentage of patients achieving treatment goal for blood pressure and LDL-C'}, {'measure': 'Changes in mean sitting systolic/diastolic blood pressure', 'timeFrame': '4, 8weeks', 'description': 'Changes in mean sitting systolic/diastolic blood pressure after 4 and 8 weeks of treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Dyslipidemias']}, 'referencesModule': {'references': [{'pmid': '38380420', 'type': 'DERIVED', 'citation': 'Park S, Hwang D, Kang J, Han JK, Yang HM, Park KW, Kang HJ, Koo BK, Cho JM, Cho BR, Ahn SG, Kang SM, Sung JH, Kim U, Lee N, Kim HS. Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients with Dyslipidemia and Hypertension: A Multicenter Randomized Clinical Trial. Curr Ther Res Clin Exp. 2024 Feb 1;100:100735. doi: 10.1016/j.curtheres.2024.100735. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study was to assess the efficacy and safety of FDC therapy with triple therapy of Telmisartan 40 mg/Amlodipine 5 mg/Rosuvastatin 10mg in Korean patients with both hypertension and dyslipidemia.', 'detailedDescription': 'Patients were randomly assigned to 2 groups: (1) Triple therapy (40mg of telmisartan and 5mg of amlodipine and 10mg of rosuvastatin); (2) Dual therapy (5mg of amlodipine and 10mg of atorvastatin). After 8 weeks of treatment, the change in mean sitting systolic blood pressure (MSSBP) and the percent change in LDL-C between 2 group, will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 145 mmHg ≤ msSBP ≤ 190 mmHg\n* Triglycerides \\< 500 mg/dL\n* LDL-C ≤ 250 mg/dL\n\nExclusion Criteria:\n\n* sSBP ≥ 20mmHg and sDBP ≥ 10mmHg\n* symptomatic orthostatic hypotension and secondary/iatrogenic hypertension and dyslipidemia\n* history of moderate to severe cerebral ischemia, cerebral hemorrhage, transient ischemic attack, myocardial infarction, or unstable angina in the past 6 months; severe heart failure (New York Heart Association functional class III and IV)\n* hypersensitivity to telmisartan or rosuvastatin\n* history of angioedema after treatment with angiotensin-converting enzyme inhibitors or ARBs; creatinine phosphokinase levels ≥3 times the upper limit of normal\n* estimated glomerular filtration rate ≤30 mL/min; aspartate aminotransferase and alanine aminotransferase levels ≥3 times the upper limit of normal\n* potassium levels \\>5.5 mmol/L; or any diseases that could affect the results of the study.'}, 'identificationModule': {'nctId': 'NCT03860220', 'briefTitle': 'The Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Multi-center, Randomized, Parallel Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients With Dyslipidemia and Hypertension', 'orgStudyIdInfo': {'id': 'STAROS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NEWSTATIN TS', 'description': 'Triple therapy (Telmisartan + Amlodipine + Rosuvastatin 40/5/10mg)', 'interventionNames': ['Drug: NEWSTATIN TS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CADUET', 'description': 'Dual therapy (Amlodipine + Atorvastatin 5/10mg)', 'interventionNames': ['Drug: CADUET']}], 'interventions': [{'name': 'NEWSTATIN TS', 'type': 'DRUG', 'otherNames': ['Newstatin TS 40/5/10mg'], 'description': 'Wash out/run in period with Amlodipine 5mg for 6 weeks and then treatment with triple therapy (Newstatin TS 40/5/10mg) ; 1 tab qd for 8 weeks', 'armGroupLabels': ['NEWSTATIN TS']}, {'name': 'CADUET', 'type': 'DRUG', 'otherNames': ['Caduet 5/10mg'], 'description': 'Wash out/run in period with Amlodipine 5mg for 6 weeks and then treatment with dual therapy (Caduet 5/10mg) ; 1 tab qd for 8 weeks', 'armGroupLabels': ['CADUET']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hak Seung Lee', 'role': 'CONTACT', 'email': 'cardiolee@gmail.com', 'phone': '82-10-3166-8399'}, {'name': 'Yuehee Yeom', 'role': 'CONTACT', 'email': 'turtree@naver.com'}], 'overallOfficials': [{'name': 'Hyo-Soo Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hyo-Soo Kim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, Coronary Intervention & Transcatheter Aortic Valve Implantation', 'investigatorFullName': 'Hyo-Soo Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}