Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT01011660
Status:
UNKNOWN
Last Update Posted:
2012-08-13
First Post:
2009-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Angiotensin II Receptor Blocker Compared With Diuretics in High-risk Hypertensive Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D000077333', 'term': 'Telmisartan'}, {'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 13542}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-09', 'studyFirstSubmitDate': '2009-11-10', 'studyFirstSubmitQcDate': '2009-11-10', 'lastUpdatePostDateStruct': {'date': '2012-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary study outcomes are composite of non-fatal stroke, non-fatal myocardial infarction and cardiovascular death.', 'timeFrame': '3-4 years'}], 'secondaryOutcomes': [{'measure': 'All cardiovascular events；all-cause death, hospitalization for angina pectoris, coronary revascularization, aortic dissection, cerebrovascular disease, heart failure, renal insufficiency, tumor, new onset of atrial fibrillation and diabetes mellitus', 'timeFrame': '3-4 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hypertension', 'cardiovascular risk factors', 'drugs intervention', 'lipid-lowering therapy', '50-79 years of age', 'sign', 'the informed', 'consent', 'forms'], 'conditions': ['Essential Hypertension']}, 'referencesModule': {'references': [{'pmid': '22329591', 'type': 'DERIVED', 'citation': 'Ma L, Wang W, Zhao Y, Zhang Y, Deng Q, Liu M, Sun H, Wang J, Liu L. Combination of amlodipine plus angiotensin receptor blocker or diuretics in high-risk hypertensive patients: a 96-week efficacy and safety study. Am J Cardiovasc Drugs. 2012 Apr 1;12(2):137-42. doi: 10.2165/11598110-000000000-00000.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the optimized treatment strategy of hypertension, so as to make more patients to reach the blood pressure goals and to reduce cardio-cerebrovascular events. Objective and Methods: Patients are eligible for inclusion in the study if they are essential hypertension, 50-79 years of age with at least one cardiovascular risk factor and sign the informed consent forms. This project is a multi-centre, prospective randomized,，openlabel blind-endpoint evaluation controlled (PROBE) trial. 12000 patients will be randomly assigned to either of low-dose Amlodipine+Telmisartan group or Amlodipine+ diuretics group. Among those patients with serum cholesterol between 4.0-6.1mmol/L, they will be also randomized into small dose of statin-based regimen or standard management regimen; Patients will also randomly assigned to intensive lifestyle intervention group or standard intervention group according to the community area where the patients in.', 'detailedDescription': 'This study is aimed to observe the main outcome (stroke, myocardial infarction and death from cardiovascular disease) differences between different groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* essential hypertension\n* 50-79 years old\n* with at least one of the cardiovascular risk factor\n* sign consent forms\n\nExclusion Criteria:\n\n* secondary hypertension\n* attack of cerebrovascular events or myocardial infarction within recent 3 months\n* coexistence of severe cardiomyopathy, rheumatic or congenital heart diseases\n* unstable angina\n* severe hepatopathy or nephropathy (ALT elevation \\> 2 fold or serum creatinine \\> 2.5mg/dl)\n* malignant tumor\n* gout\n* women taking contraceptives or with pregnancy\n* allergic history to the research drugs\n* validated contradiction to the research drugs\n* participating in other clinical trials\n* unable for long-term follow-up or poor compliance\n* unsuitable for clinical trial at the discretion of doctors in charge'}, 'identificationModule': {'nctId': 'NCT01011660', 'acronym': 'CHIEF', 'briefTitle': 'Effects of Angiotensin II Receptor Blocker Compared With Diuretics in High-risk Hypertensive Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}, 'officialTitle': 'Phase 4 Study of Effects of ARB Compared With Diuretics in Hypertension Patients With High Cardiovascular Risks', 'orgStudyIdInfo': {'id': '115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A,1,IV', 'description': 'A means active; 1 means Amlodipine+Amiloride Compound; IV means phase IV', 'interventionNames': ['Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A,2,IV', 'description': 'A means active; 2 means Amlodipine+Telmisartan; IV means phase IV', 'interventionNames': ['Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A,3,IV', 'description': 'A means active; 3 means Amlodipine+Amiloride Compound with or no Simvastatin; IV means phase IV', 'interventionNames': ['Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A,4,IV', 'description': 'A means active; 4 means Amlodipine+Telmisartan with or no Simvastatin; IV means phase IV', 'interventionNames': ['Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin']}], 'interventions': [{'name': 'Amlodipine, Telmisartan, Amiloride Compound , Simvastatin', 'type': 'DRUG', 'otherNames': ['CHIEF'], 'description': 'Amlodipine; Telmisartan; Amiloride Compound; Simvastatin', 'armGroupLabels': ['A,1,IV', 'A,2,IV', 'A,3,IV', 'A,4,IV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liyuan Ma', 'role': 'CONTACT', 'email': 'maliyuan600@vip.sina.com', 'phone': '86 10 68335002'}, {'name': 'Wen Wang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wang Wen', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Wen Wang, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Ma Liyuan', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}}}}