Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 7:04 PM
Study NCT ID:
NCT00129233
Status:
COMPLETED
Last Update Posted:
2013-05-01
First Post:
2005-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006943', 'term': 'Hyperglycemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068756', 'term': 'Valsartan'}, {'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014633', 'term': 'Valine'}, {'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-29', 'studyFirstSubmitDate': '2005-08-10', 'studyFirstSubmitQcDate': '2005-08-10', 'lastUpdatePostDateStruct': {'date': '2013-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite cardiovascular events including fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, admission due to heart failure, coronary intervention and sudden cardiac death', 'timeFrame': 'At least 3 years of mean follow up period'}], 'secondaryOutcomes': [{'measure': 'total death', 'timeFrame': 'At least 3 years of mean follow up period'}, {'measure': 'cardiac function evaluated by ultrasonography', 'timeFrame': 'At least 3 years of mean follow up period'}, {'measure': 'incidence of atrial fibrillation/flutter', 'timeFrame': 'At least 3 years of mean follow up period'}, {'measure': 'control of blood glucose', 'timeFrame': 'At least 3 years of mean follow up period'}, {'measure': 'renal function', 'timeFrame': 'At least 3 years of mean follow up period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cardiovascular disease', 'rennin-angiotensin system', 'calcium channel blocker', 'impaired glucose tolerance'], 'conditions': ['Hypertension', 'Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '15207952', 'type': 'BACKGROUND', 'citation': 'Julius S, Kjeldsen SE, Weber M, Brunner HR, Ekman S, Hansson L, Hua T, Laragh J, McInnes GT, Mitchell L, Plat F, Schork A, Smith B, Zanchetti A; VALUE trial group. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet. 2004 Jun 19;363(9426):2022-31. doi: 10.1016/S0140-6736(04)16451-9.'}, {'pmid': '24035165', 'type': 'DERIVED', 'citation': 'Yamashita K, Kondo T, Muramatsu T, Matsushita K, Nagahiro T, Maeda K, Shintani S, Murohara T. Effects of valsartan versus amlodipine in diabetic hypertensive patients with or without previous cardiovascular disease. Am J Cardiol. 2013 Dec 1;112(11):1750-6. doi: 10.1016/j.amjcard.2013.07.043. Epub 2013 Sep 13.'}, {'pmid': '22232134', 'type': 'DERIVED', 'citation': 'Muramatsu T, Matsushita K, Yamashita K, Kondo T, Maeda K, Shintani S, Ichimiya S, Ohno M, Sone T, Ikeda N, Watarai M, Murohara T; NAGOYA HEART Study Investigators. Comparison between valsartan and amlodipine regarding cardiovascular morbidity and mortality in hypertensive patients with glucose intolerance: NAGOYA HEART Study. Hypertension. 2012 Mar;59(3):580-6. doi: 10.1161/HYPERTENSIONAHA.111.184226. Epub 2012 Jan 9.', 'retractions': [{'pmid': '30354774', 'source': 'Hypertension. 2018 Sep;72(3):e37-e38'}]}, {'pmid': '20409690', 'type': 'DERIVED', 'citation': 'Matsushita K, Muramatsu T, Kondo T, Maeda K, Shintani S, Murohara T; NAGOYA HEART Study Group. Rationale and design of the NAGOYA HEART Study: comparison between valsartan and amlodipine regarding morbidity and mortality in patients with hypertension and glucose intolerance. J Cardiol. 2010 Jul;56(1):111-7. doi: 10.1016/j.jjcc.2010.03.004. Epub 2010 Apr 20.'}]}, 'descriptionModule': {'briefSummary': 'Various guidelines recommended angiotensin converting enzyme (ACE) inhibitors or angiotensin Ⅱ receptor-1 blockers (ARBs) for hypertensive patients with diabetes on the basis of the cardiac- and reno-protective effects of these drugs. However, these recommendations could not be extrapolated to Japanese patients, because Japan has been known as a country with a low incidence of coronary artery disease and a high incidence of cerebrovascular disease. Furthermore, calcium channel blockers (CCBs) also were protective against renal function as well as ACE inhibitors in Japanese diabetic hypertensive patients. This study will test whether ARBs or CCBs are superior in treating Japanese diabetic hypertensive patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of hypertension\n* Clinical diagnosis of type 2 diabetes or impaired glucose tolerance\n\nExclusion Criteria:\n\n* History of congestive heart failure, myocardial infarction, or coronary revascularization in the recent 6 months.\n* Taking calcium channel blocker for the purpose of angina pectoris\n* Reduced ejection fraction (\\< 40%)\n* Second- or third-degree of atrioventricular block\n* Severe hypertension (\\> 200/110 mmHg) or secondary hypertension\n* History of stroke in the recent 6 months\n* Serum creatinine \\> 2.5 mg/dl\n* Estimated survival duration less than 3 years due to other conditions\n* Pregnant woman or possibly pregnant woman'}, 'identificationModule': {'nctId': 'NCT00129233', 'briefTitle': 'Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance', 'organization': {'class': 'OTHER', 'fullName': 'Nagoya University'}, 'officialTitle': 'The Novel Antihypertensive Goal Of hYpertension With diAbetes - Hypertensive Events and ARb Treatment (NAGOYA-HEART) Study', 'orgStudyIdInfo': {'id': '169'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Valsartan', 'description': 'Valsartan group treated with 80-160mg daily valsartan without Ca channel blockers or ACE inhibitors.', 'interventionNames': ['Drug: Valsartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Amlodipine', 'description': 'Amlodipine group treated with 5-10mg daily amlodipine without ACE inhibitors or angiotensin receptor blockers.', 'interventionNames': ['Drug: Amlodipine']}], 'interventions': [{'name': 'Valsartan', 'type': 'DRUG', 'description': 'valsartan 80 to 160 mg daily', 'armGroupLabels': ['Valsartan']}, {'name': 'Amlodipine', 'type': 'DRUG', 'description': 'Amlodipine 5 to 10 mg daily.', 'armGroupLabels': ['Amlodipine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '466-8550', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Department of Cardiology, Nagoya University Graduate School of Medicine', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}], 'overallOfficials': [{'name': 'Toyoaki Murohara, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiology, Nagoya University Graduate School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nagoya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Proffesor', 'investigatorFullName': 'TOYOAKI MUROHARA', 'investigatorAffiliation': 'Nagoya University'}}}}