Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-02-25 @ 2:35 AM
Study NCT ID:
NCT03255551
Status:
COMPLETED
Last Update Posted:
2017-08-21
First Post:
2017-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Pressure Lowering Effects of Amosartan Regarding Proviso iN Patients With High Blood Pressure
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-16', 'studyFirstSubmitDate': '2017-08-16', 'studyFirstSubmitQcDate': '2017-08-16', 'lastUpdatePostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients with essential hypertension evaluated the mean blood pressure after taking amosartan.', 'timeFrame': '6 month', 'description': 'Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients with Hypertension'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '22035131', 'type': 'BACKGROUND', 'citation': 'Kim SH, Ryu KH, Lee NH, Kang JH, Kim WS, Park SW, Lee HY, Kim JJ, Ahn YK, Suh SY. Efficacy of fixed-dose amlodipine and losartan combination compared with amlodipine monotherapy in stage 2 hypertension: a randomized, double blind, multicenter study. BMC Res Notes. 2011 Oct 28;4:461. doi: 10.1186/1756-0500-4-461.'}, {'pmid': '12829555', 'type': 'BACKGROUND', 'citation': 'Law MR, Wald NJ, Morris JK, Jordan RE. Value of low dose combination treatment with blood pressure lowering drugs: analysis of 354 randomised trials. BMJ. 2003 Jun 28;326(7404):1427. doi: 10.1136/bmj.326.7404.1427.'}, {'pmid': '19387578', 'type': 'BACKGROUND', 'citation': 'Choi SM, Seo MJ, Kang KK, Kim JH, Ahn BO, Yoo M. Beneficial effects of the combination of amlodipine and losartan for lowering blood pressure in spontaneously hypertensive rats. Arch Pharm Res. 2009 Mar;32(3):353-8. doi: 10.1007/s12272-009-1307-x. Epub 2009 Apr 23.'}]}, 'descriptionModule': {'briefSummary': 'Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients with Hypertension', 'detailedDescription': 'After taking Amozatan (AMS, amlodipine / rozanthin combination) in patients with essential hypertension, the percentage of patients who reached the mean systolic target blood pressure was evaluated'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Estimated total number of patients: 3,150 Estimated number of centers: 37', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with essential hypertension whose blood pressure is not adequately controlled by amlodipine or rosartan monotherapy\n* In patients with stage 2 hypertension (SBP 160-179 mmHg), patients requiring a combination therapy to reach the target blood pressure\n* Patients who were changed to amosartan while using other hypertensive agents\n\nExclusion Criteria:\n\n* Patients with hypersensitivity to dihydropyridine derivatives of amosartan\n* Women who are pregnant or who may be pregnant and breastfeeding\n* Patients with severe hepatic dysfunction\n* Patients with severe aortic stenosis\n* Patients at risk of shock\n* Patients participating in other clinical studies'}, 'identificationModule': {'nctId': 'NCT03255551', 'briefTitle': 'Blood Pressure Lowering Effects of Amosartan Regarding Proviso iN Patients With High Blood Pressure', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients With Hypertension: Prospective, Multicenter, Observational Study', 'orgStudyIdInfo': {'id': 'LEARN BP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Amosartan', 'type': 'DRUG', 'description': 'amosartan is a combination of amlodipine, which is a calcium channel blocker (CCB), and rozatan, an angiotensin II receptor antagonist (ARB), and is an antihypertensive agent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Seoul National University Bundang Hospital', 'investigatorFullName': 'Dong-Ju Choi', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}