Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-01-01 @ 11:19 PM
Study NCT ID:
NCT00669435
Status:
UNKNOWN
Last Update Posted:
2008-04-30
First Post:
2008-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Losartan and Simvastatin in Hypertensive Obeses With Liver Steatosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D000075222', 'term': 'Essential Hypertension'}, {'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019808', 'term': 'Losartan'}, {'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'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': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2009-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-04-28', 'studyFirstSubmitDate': '2008-04-25', 'studyFirstSubmitQcDate': '2008-04-28', 'lastUpdatePostDateStruct': {'date': '2008-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All patients will undergo anthropometric evaluation and abdominal ultrasonography (performed by the same examiner); will be taken routine liver US and US measurement of visceral and subcutaneous fat.', 'timeFrame': 'Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months'}], 'secondaryOutcomes': [{'measure': 'Determination of insulin sensitivity, leptin, adiponectin, TNFα, IL6, hsPCR', 'timeFrame': 'Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Essential hypertension', 'Liver steatosis'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'Angiotensin II has been proposed as a lipid metabolism regulator. It is known that adipocytes secrete a variety of protein, such as TNFα, plasminogen activator inhibitor (PAI)-1, leptin, resistin and adiponectin; these proteins have a wide range of biological effects and are associated with insulin resistance. Adipocytes also produce angiotensinogen and angiotensin II and a local renin-angiotensin system (RAS) is present in adipose tissue. In overweight or obese hypertensive normocholesterolemic patients the treatment with AT1-receptor blocker (Losartan) may have a better effect on hepatic steatosis and visceral fat deposition than the antihypertensive treatment with calcium channel blocker (amlodipine). Simvastatin will be added to both groups. The aim of this study is to evaluate the effect of losartan and simvastatin on ultrasonographic qualitative and quantitative parameters in overweight or obese hypertensive normocholesterolemic patients with hepatic steatosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gender: 50% Male and 50% female\n* Age: 40-80 years\n* Race: Caucasian\n* Overweight or obese: respectively BMI25-30 kg/m2 or BMI \\> 30 kg m2\n* Hypertensive: PA \\> 140/90 mmHg\n* Normocholesterolemic (LDL\\< 160 mg/dl HDL \\> 35 mg/dl)\n* Liver steatosis\n\nExclusion Criteria:\n\n* other antihypertensive treatment after wash out period of 2 weeks\n* abnormal heart rest function (EF \\< 55%).\n* valvular heart disease\n* congenital heart disease\n* heart failure or prior myocardial infarction\n* diabetes\n* renal disease\n* liver disease\n* connective tissue disease\n* pregnancy or lactation\n* serious adverse experience\n* sensitivity to the study drugs or its components\n* contraindication from an approved label'}, 'identificationModule': {'nctId': 'NCT00669435', 'briefTitle': 'Losartan and Simvastatin in Hypertensive Obeses With Liver Steatosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Pavia'}, 'officialTitle': 'Ultrasonographic Modification of Liver Steatosis and Visceral Fat Induced by Treatment With Losartan and Simvastatin in Hypertensive Normocholesterolemic Obese Patients', 'orgStudyIdInfo': {'id': 'UNIPV003DIM2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Amlodipine and Simvastatin', 'interventionNames': ['Drug: Amlodipine + Simvastatin']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Losartan and Simvastatin', 'interventionNames': ['Drug: Losartan + Simvastatin']}], 'interventions': [{'name': 'Losartan + Simvastatin', 'type': 'DRUG', 'description': 'tablets; 50, 100 mg; od; 12 months\n\ntablets; 20 mg; od; 6 months', 'armGroupLabels': ['2']}, {'name': 'Amlodipine + Simvastatin', 'type': 'DRUG', 'description': 'tablets; 5, 10 mg; od; 12 months\n\ntablets; 20 mg; od; 6 months', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Derosa, MD', 'role': 'CONTACT', 'phone': '39-038-250-2614'}], 'facility': 'University of Pavia', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'centralContacts': [{'name': 'Giuseppe Derosa', 'role': 'CONTACT', 'phone': '39-038-250-2614'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pavia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Giuseppe Derosa/MD', 'oldOrganization': 'University of Pavia'}}}}