Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT01017835
Status:
UNKNOWN
Last Update Posted:
2009-11-23
First Post:
2009-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Simvastatin in Patients With Isolated Arterial Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-11-20', 'studyFirstSubmitDate': '2009-11-20', 'studyFirstSubmitQcDate': '2009-11-20', 'lastUpdatePostDateStruct': {'date': '2009-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['statins', 'isolated hypertension', 'atherosclerosis', 'lipid profile'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '19555312', 'type': 'BACKGROUND', 'citation': 'Stepien M, Banach M, Mikhailidis DP, Gluba A, Kjeldsen SE, Rysz J. Role and significance of statins in the treatment of hypertensive patients. Curr Med Res Opin. 2009 Aug;25(8):1995-2005. doi: 10.1185/03007990903098081.'}, {'pmid': '19368496', 'type': 'BACKGROUND', 'citation': 'Rysz J, Aronow WS, Stolarek RS, Hannam S, Mikhailidis DP, Banach M. Nephroprotective and clinical potential of statins in dialyzed patients. Expert Opin Ther Targets. 2009 May;13(5):541-50. doi: 10.1517/14728220902882130.'}, {'pmid': '19217673', 'type': 'BACKGROUND', 'citation': 'Szadkowska I, Stanczyk A, Aronow WS, Kowalski J, Pawlicki L, Ahmed A, Banach M. Statin therapy in the elderly: a review. Arch Gerontol Geriatr. 2010 Jan-Feb;50(1):114-8. doi: 10.1016/j.archger.2008.12.012. Epub 2009 Feb 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether combined therapy with simvastatin and hypotensive drugs (ACEI or ARB) may decrease the blood pressure. Moreover, we would like to assess the influence of isolated hypertension on endothelial injury, and on the development of atherosclerosis.', 'detailedDescription': 'Hypertension is one of the most important predictors of cardiovascular diseases (CVD). Due to the fact that hypertension frequently coexists with hypercholesterolemia and diabetes which increase the risk of CVDs development, it is advisable to use the optimal combined therapy (hypotensive + hypolipidemic + hypoglycemic)in this group of patients. Statins are the most effective and widely used drugs for the treatment of hypercholesterolemia. According to the available experimental and clinical data they may decrease the blood pressure (BP) in normotensive and hypertensive patients. However, it is still difficult to determine to what degree the reduction of both blood pressure and cardiovascular risk is due to hypotensive or hypolipidemic/pleiotropic effects of statins.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized in the Department of Nephrology, Hypertension and Family Medicine,Clinical Hospital of Medical University of Lodz', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* isolated hypertension (I or II class according to ESH guidelines 2009)\n\nExclusion Criteria:\n\n* ischemic heart disease, prior percutaneous coronary intervention (PCI), prior coronary artery bypass grafting (CABG), heart failure, diabetes, hyperlipidemia, active smokers'}, 'identificationModule': {'nctId': 'NCT01017835', 'acronym': 'STIPPARE', 'briefTitle': 'Simvastatin in Patients With Isolated Arterial Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Lodz'}, 'officialTitle': 'Simvastatin in the Treatment of Isolated Arterial hyPertension and Prevention of cARdiovascular Events', 'orgStudyIdInfo': {'id': '503-5139-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'statin treatment, isolated hypertension', 'description': 'treatment with statins, patients with isolated hypertension, with no hyperlipidemia, no diabetes, no smoking'}, {'label': 'placebo treatment, isolated hypertension', 'description': 'treatment with placebo, patients with isolated hypertension, with no hyperlipidemia, no diabetes, no smoking'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90-549', 'city': 'Lodz', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Departament of Nephrology, Hypertension and Family Medicine, Clinical Hospital of Medical University of Lodz', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}], 'centralContacts': [{'name': 'Marta Michalska, MSc', 'role': 'CONTACT', 'email': 'michalska_marta84@wp.pl', 'phone': '501154853', 'phoneExt': '+48'}, {'name': 'Maciej Banach, MD PhD', 'role': 'CONTACT', 'email': 'maciejbanach@aol.co.uk', 'phone': '604593040', 'phoneExt': '+48'}], 'overallOfficials': [{'name': 'Maciej Banach, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Departament of Hypertension , Medical University of Lodz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Lodz', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Maciej Banach', 'oldOrganization': 'Departament of Hypertension'}}}}