Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-28 @ 10:37 AM
Study NCT ID:
NCT00356395
Status:
COMPLETED
Last Update Posted:
2006-07-26
First Post:
2006-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Effects of Ramipril Combined With Candesartan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017257', 'term': 'Ramipril'}, {'id': 'C081643', 'term': 'candesartan'}], 'ancestors': [{'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-03', 'completionDateStruct': {'date': '2006-03'}, 'lastUpdateSubmitDate': '2006-07-25', 'studyFirstSubmitDate': '2006-07-25', 'studyFirstSubmitQcDate': '2006-07-25', 'lastUpdatePostDateStruct': {'date': '2006-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparison of endothelium-dependent dilation among the 3 treatment schemes'}]}, 'conditionsModule': {'keywords': ['endothelial function, insulin resistance, adipocytokines'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'we hypothesized that combination therapy has additive beneficial effects to improve endothelial dysfunction and adipocytokine profiles in patients with hypertension.', 'detailedDescription': 'Forty patients will be given ramipril 10 mg and placebo, ramipril 10 mg and candesartan 16 mg, or candesartan 16 mg and placebo daily in a randomized, double-blind, placebo-controlled cross-over trial with three treatment arms and two washout periods (each 2 months).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with mild to moderate hypertension\n\nExclusion Criteria:\n\n* We will exclude patients with severe hypertension, unstable angina, acute myocardial infarction, or renal insufficiency.'}, 'identificationModule': {'nctId': 'NCT00356395', 'briefTitle': 'Safety and Effects of Ramipril Combined With Candesartan', 'organization': {'class': 'OTHER', 'fullName': 'Gachon University Gil Medical Center'}, 'officialTitle': 'Cardiovascular and Metabolic Effects of Combination Therapy With Ramipril and Candesartan In Hypertensive Patients', 'orgStudyIdInfo': {'id': '2003-008'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ramipril, candesartan', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kwang K Koh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiology, Gil Heart Center, Gachon Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}}}}