Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT01713920
Status:
COMPLETED
Last Update Posted:
2015-11-10
First Post:
2012-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerability of Combination Antihypertensive Drug in Non-Responders to ARB monoTHerapy Using 24h ABPM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-06', 'studyFirstSubmitDate': '2012-10-22', 'studyFirstSubmitQcDate': '2012-10-23', 'lastUpdatePostDateStruct': {'date': '2015-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in mean 24-hour ABPM SBP', 'timeFrame': 'from baseline to Week 12'}], 'secondaryOutcomes': [{'measure': 'value of cuff SeSBP/SeDBP', 'timeFrame': 'baseline, week 4, week 8 and week 12'}, {'measure': 'change in aortic PWV', 'timeFrame': 'from baseline to week 4, week 8, week 12'}, {'measure': 'change in 24-hour ABPM DBP', 'timeFrame': 'baseline to week 12'}, {'measure': 'change in hsCRP, HOMA-IR, MAU, Uric acid', 'timeFrame': 'from baseline to week 12'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Korean National Health & Nutrition Examination Surveys. Available from: URL://http://knhanes.cdc.go.kr/'}, {'pmid': '9635947', 'type': 'BACKGROUND', 'citation': 'Hansson L, Zanchetti A, Carruthers SG, Dahlof B, Elmfeldt D, Julius S, Menard J, Rahn KH, Wedel H, Westerling S. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomised trial. HOT Study Group. Lancet. 1998 Jun 13;351(9118):1755-62. doi: 10.1016/s0140-6736(98)04311-6.'}, {'pmid': '12479764', 'type': 'BACKGROUND', 'citation': 'ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Major outcomes in moderately hypercholesterolemic, hypertensive patients randomized to pravastatin vs usual care: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT). JAMA. 2002 Dec 18;288(23):2998-3007. doi: 10.1001/jama.288.23.2998.'}, {'pmid': '16154016', 'type': 'BACKGROUND', 'citation': "Dahlof B, Sever PS, Poulter NR, Wedel H, Beevers DG, Caulfield M, Collins R, Kjeldsen SE, Kristinsson A, McInnes GT, Mehlsen J, Nieminen M, O'Brien E, Ostergren J; ASCOT Investigators. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial. Lancet. 2005 Sep 10-16;366(9489):895-906. doi: 10.1016/S0140-6736(05)67185-1."}, {'pmid': '16154017', 'type': 'BACKGROUND', 'citation': "Poulter NR, Wedel H, Dahlof B, Sever PS, Beevers DG, Caulfield M, Kjeldsen SE, Kristinsson A, McInnes GT, Mehlsen J, Nieminen M, O'Brien E, Ostergren J, Pocock S; ASCOT Investigators. Role of blood pressure and other variables in the differential cardiovascular event rates noted in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA). Lancet. 2005 Sep 10-16;366(9489):907-13. doi: 10.1016/S0140-6736(05)67186-3."}, {'pmid': '18498909', 'type': 'BACKGROUND', 'citation': 'Chrysant SG, Melino M, Karki S, Lee J, Heyrman R. The combination of olmesartan medoxomil and amlodipine besylate in controlling high blood pressure: COACH, a randomized, double-blind, placebo-controlled, 8-week factorial efficacy and safety study. Clin Ther. 2008 Apr;30(4):587-604. doi: 10.1016/j.clinthera.2008.04.002.'}, {'pmid': '12748199', 'type': 'BACKGROUND', 'citation': 'Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.'}, {'pmid': '17563527', 'type': 'BACKGROUND', 'citation': "Mancia G, De Backer G, Dominiczak A, Cifkova R, Fagard R, Germano G, Grassi G, Heagerty AM, Kjeldsen SE, Laurent S, Narkiewicz K, Ruilope L, Rynkiewicz A, Schmieder RE, Boudier HA, Zanchetti A, Vahanian A, Camm J, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Erdine S, Kiowski W, Agabiti-Rosei E, Ambrosioni E, Lindholm LH, Viigimaa M, Adamopoulos S, Agabiti-Rosei E, Ambrosioni E, Bertomeu V, Clement D, Erdine S, Farsang C, Gaita D, Lip G, Mallion JM, Manolis AJ, Nilsson PM, O'Brien E, Ponikowski P, Redon J, Ruschitzka F, Tamargo J, van Zwieten P, Waeber B, Williams B; Management of Arterial Hypertension of the European Society of Hypertension; European Society of Cardiology. 2007 Guidelines for the Management of Arterial Hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2007 Jun;25(6):1105-87. doi: 10.1097/HJH.0b013e3281fc975a. No abstract available."}, {'pmid': '39504016', 'type': 'DERIVED', 'citation': 'Chung WB, Ihm SH, Choi YS, Youn HJ. Efficacy of Olmesartan/Amlodipine Single-Pill Combination on 24-h Mean Systolic Blood Pressure Measured by Ambulatory Monitoring in Non-Responders to Valsartan or Candesartan Monotherapy. J Clin Hypertens (Greenwich). 2025 Jan;27(1):e14929. doi: 10.1111/jch.14929. Epub 2024 Nov 6.'}]}, 'descriptionModule': {'briefSummary': 'A majority of Korean doctors tend to add other antihypertensive rather than to titrate the same drug.\n\nHowever, we try to induce doctors to titrate the Sevikar than to add other antihypertensive if patients are not controlled with Sevikar 5/20mg(amlodipine 5mg + omlesartan 20mg). As above, for patients who are not controlled with Sevikar 5/20mg, doctors will proceed to other prescription pattern with other choices of titration to Sevikar 5/40, 10/40mg.\n\nIt is important to evaluate BP lowering efficacy of Sevikar through the titration step in patients uncontrolled with Sevikar low dose. Thus, this study is designed to demonstrate the efficacy of Sevikar by titration in patients who are not controlled their BP with low dose of Sevikar.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male and female subjects \\> 55 years\n2. Subject who has consent to participate by signing on the informed consent form\n3. Uncontrolled hypertensive patients defined as:\n\n * Uncontrolled hypertensive: subjects who are mean SBP ≥ 140 mmHg after being treated with ARB(Valsartan 80mg or Candesartan 8mg) monotherapy during at least 4 weeks.\n\nExclusion Criteria:\n\n1. Secondary hypertension\n2. SeSBP ≥ 180mmHg\n3. SeSBP difference ≥ 20mmHg or SeDBP difference ≥ 10mmHg\n4. A history of hypertensive encephalopathy, unstable angina, transient ischemic attack, MI, or any type of revascularization procedure within the last 6 months\n5. Heart failure, second- or third-degree heart block, significant arrhythmia or valvular heart disease\n6. Significant cardiovascular, cerebrovascular, renal, gastrointestinal, or hematologic disease, at the discretion of investigator\n7. Creatinine clearance\\<20mL/min and Renal artery stenosis, Renal Transplantation, Patients with only one kidney\n8. Evidence of liver disease as indicated by alanine transaminase (ALT) and aspartate transaminase (AST) and/or total bilirubin ≥ 3 × the upper limit of normal (ULN)\n9. Hyperkalemia (\\>5.5mmol/L)\n10. Patients with sodium depletion is not correct or Patients with fluid depletion is not correct\n11. Chronic inflammation\n12. Patients with severe eye-related disorders (Retinal bleeding within 6 months, Blindness, Hypertension complications with Retinal micro-aneurysms)\n13. Diabetes mellitus\n14. Hematologic/oncologic, neurologic and psychiatric diseases\n15. Females who were pregnant, breastfeeding, planning a pregnancy or who were of childbearing potential\n16. Contraindications for amlodipine, losartan, olmesartan medoxomil, or other ARBs\n17. With known allergic reaction, lack of response or contraindication to Angiotensin II receptor antagonists\n18. Mean DBP \\> 110 mmHg\n19. Patients who took antihyperlipidemic agents within 30 days\n20. Subject who have participated in other clinical trial within the last one month\n21. Any subjects who are unable to cooperate with protocol requirements and follow-up procedures or who are in medical condition that is not eligible to be entered in investigators' discretion"}, 'identificationModule': {'nctId': 'NCT01713920', 'acronym': 'EARTH', 'briefTitle': 'Efficacy and Tolerability of Combination Antihypertensive Drug in Non-Responders to ARB monoTHerapy Using 24h ABPM', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'Efficacy and Tolerability of Combination Antihypertensive Drug in Non-Responders to Angiotensin Receptor Blocker(ARB) monoTHerapy Using 24h ABPM.', 'orgStudyIdInfo': {'id': 'EARTH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SEVIKAR', 'description': 'Subjects who are eligible for the inclusion and exclusion criteria will be treated with Sevikar 5/20mg for 4 weeks. If subjects fail to reach the SBP threshold of SeSBP≥ 140mmHg after 4-week treatment, they will receive Sevikar 5/40mg for 4 weeks. At the end of 4-week treatment, subjects who fail to reach SBP threshold will receive Sevikar 10/40mg for 4 weeks. Subjects who can reach SBP threshold will continue to treat with current dose until 12 weeks.', 'interventionNames': ['Drug: SEVIKAR']}], 'interventions': [{'name': 'SEVIKAR', 'type': 'DRUG', 'otherNames': ['amlodipine + olemsartan'], 'armGroupLabels': ['SEVIKAR']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bucheon-si', 'country': 'South Korea', 'facility': "The Catholic University of Korea Bucheon St. Mary's Hospital", 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sang Hyun Ihm, MD PhD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Daiichi Sankyo Korea Co., Ltd.', 'class': 'INDUSTRY'}, {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor , Division of Cardiology, Department of Internal Medicine', 'investigatorFullName': 'Sang Hyun Ihm, MD PhD', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}