Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-28 @ 9:04 PM
Study NCT ID:
NCT00529750
Status:
COMPLETED
Last Update Posted:
2011-01-12
First Post:
2007-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the Angiotensin II Receptor Antagonist Irbesartan on Biochemical and Functional Markers of Endothelial Dysfunction in Patients With 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': 'D000077405', 'term': 'Irbesartan'}, {'id': 'D001262', 'term': 'Atenolol'}], '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': 'D013141', 'term': 'Spiro Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-11', 'studyFirstSubmitDate': '2007-09-12', 'studyFirstSubmitQcDate': '2007-09-12', 'lastUpdatePostDateStruct': {'date': '2011-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial function in vivo qualification: brachial artery flow mediated vasodilation (FMV%) determined by high resolution ultrasound.', 'timeFrame': 'at baseline and at the end of the study-12th wk'}]}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'Primary:\n\n* To evaluate the impact of irbesartan on endothelial function in hypertensive patients with metabolic syndrome.\n\nSecondary:\n\n* To evaluate the oxidative stress status in patients with hypertension with metabolic syndrome.\n* To correlate the oxidative stress status with endothelial function in these patients.\n* To evaluate the effect of irbesartan on the oxidative stress stage in patients with metabolic syndrome and to correlate it with the effect on endothelial function .\n* To correlate the change in endothelial function and oxidative stress stage with the change of arterial pressure levels.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Hypertension grade 1 or 2\n* With at least two of the following criteria for the diagnosis of metabolic syndrome:\n\n * Body mass index \\> or = 25 kg/m2 AND waist circumference \\> or = 100 cm.\n * Dyslipidemia (triglycerides fasting serum levels \\> or = 200 mg/dL OR HDL serum levels \\< or = 40 mg/dL)\n * Fasting serum glucose \\> or = 110 mg/dL but \\< 126 mg/dL\n\nExclusion Criteria:\n\n* Known hypersensitivity to Irbesartan\n* Hypertension grade 3\n* History of clinical vascular events such as TIAs, stroke, peripheral arterial disease\n* Coronary artery disease\n* Renal insufficiency (creatinine serum levels \\> or = 1.2 mg/dL)\n* Presence of clinical heart failure\n* Asthma and COPD\n* Valvular cardiopathy clinically relevant\n* Current therapy with antioxidant drugs, statins\n* Therapy with AIIRA for at least 3 months during the last semester\n* Presence of any acute illness or major trauma in the last 8 weeks\n* History of a chronic inflammatory disease such as rheumatoid arthritis, immune disorders or connective tissue disease.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00529750', 'briefTitle': 'Effect of the Angiotensin II Receptor Antagonist Irbesartan on Biochemical and Functional Markers of Endothelial Dysfunction in Patients With Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Comparative Trial of the Effects of Irbesartan vs Atenolol on the Endothelial Function of Hypertensive Patients With Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'L_8261'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Irbesartan Group', 'description': '150 mg p.o. once a day, 30 minutes before breakfast during 12 weeks', 'interventionNames': ['Drug: IRBESARTAN']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atenolol Group', 'description': '50 mg p.o. once a day, 30 minutes before breakfast during 12 weeks.', 'interventionNames': ['Drug: Atenolol']}], 'interventions': [{'name': 'IRBESARTAN', 'type': 'DRUG', 'description': 'Tablets', 'armGroupLabels': ['Irbesartan Group']}, {'name': 'Atenolol', 'type': 'DRUG', 'description': 'Tablets', 'armGroupLabels': ['Atenolol Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Juan Carlos Gomez', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}}}}