Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:42 PM
Study NCT ID:
NCT00940667
Status:
COMPLETED
Last Update Posted:
2016-10-12
First Post:
2009-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Essential Hypertension
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'}, {'id': 'D019808', 'term': 'Losartan'}], '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': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D013777', 'term': 'Tetrazoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-10', 'studyFirstSubmitDate': '2009-07-14', 'studyFirstSubmitQcDate': '2009-07-15', 'lastUpdatePostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in mean sitting diastolic blood pressure', 'timeFrame': 'Week 8'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in mean sitting diastolic blood pressure', 'timeFrame': 'Week 4'}, {'measure': 'Change from baseline in mean sitting systolic blood pressure', 'timeFrame': 'Week 4, 8'}, {'measure': 'Responder rate', 'timeFrame': 'Week 4, 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Amlodipine', 'Losartan', 'hypertension'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '22136978', 'type': 'DERIVED', 'citation': 'Kang SM, Youn JC, Chae SC, Park CG, Yang JY, Kim MH, Hong TJ, Kim CH, Kim JJ, Shin DG, Jeong JW, Yoon JH, Park SH, Kwon J, Cho SY. Comparative efficacy and safety profile of amlodipine 5 mg/losartan 50 mg fixed-dose combination and amlodipine 10 mg monotherapy in hypertensive patients who respond poorly to amlodipine 5 mg monotherapy: an 8-week, multicenter, randomized, double-blind phase III noninferiority study. Clin Ther. 2011 Dec;33(12):1953-63. doi: 10.1016/j.clinthera.2011.11.007. Epub 2011 Dec 2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate of efficacy and safety of amlodipine plus losartan and amlodipine alone in patients with essential hypertension inadequately controlled on amlodipine monotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age\n* Essential hypertensive patients whose blood pressure is not controlled before the study (sit DBP ≥ 90 mmHg for drug-treated patient, sit DBP ≥ 95 mmHg for drug-naïve patient)\n* Non-responder to 4 weeks treatment of amlodipine 5 mg monotherapy (sit DBP ≥ 90mmHg)\n\nExclusion Criteria:\n\n* mean sit SBP ≥ 200 mmHg or mean sit DBP ≥ 120 mmHg at screening\n* mean sit SBP ≥ 180 mmHg or mean sit DBP ≥ 120 mmHg after 4 weeks of amlodipine 5 mg treatment\n* has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers\n* Secondary hypertensive patient or suspected to be\n* Uncontrolled diabetes mellitus patients\n* Severe heart disease or severe neurovascular disease\n* Known as severe or malignant retinopathy\n* Patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (ALT or AST)\n* History of malignancy tumor\n* History of autoimmune disease\n* History of alcohol or drug abuse\n* Positive to pregnancy test, nursing mother, has an intention on pregnancy\n* Considered by investigator as not appropriate to participate in the clinical study with othe reason'}, 'identificationModule': {'nctId': 'NCT00940667', 'briefTitle': 'Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Essential Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'A Phase III, 8-week, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Amlodipine 5mg+Losartan 50mg Versus Amlodipine 10mg in Patients With Essential Hypertension Not Controlled on Amlodipine Monotherapy', 'orgStudyIdInfo': {'id': 'HM-ALOS-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'amlodipine/losartan 5/50mg', 'interventionNames': ['Drug: Amlodipine plus Losartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'amlodipine 5mg', 'interventionNames': ['Drug: Amlodipine']}], 'interventions': [{'name': 'Amlodipine plus Losartan', 'type': 'DRUG', 'otherNames': ['Amosartan'], 'description': 'amlodipine/losartan 5/50mg q.d.', 'armGroupLabels': ['amlodipine/losartan 5/50mg']}, {'name': 'Amlodipine', 'type': 'DRUG', 'otherNames': ['Amodpine'], 'description': 'amlodipine 5mg q.d.', 'armGroupLabels': ['amlodipine 5mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul, Busan, Etc.', 'country': 'South Korea', 'facility': '13 sites in Korea'}], 'overallOfficials': [{'name': 'Seung-Yun Cho, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}