Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-06-14 @ 8:08 AM
Study NCT ID:
NCT01819220
Status:
COMPLETED
Last Update Posted:
2015-06-10
First Post:
2013-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized, Open Labeled Clinical Trial to Compare the Effectiveness of Amlodipine/Valsartan vs Hydrochlorothiazide/Telmisartan on Glucose Tolerance in Patients With Hypertension With Metabolic Syndrome
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': 'D000068838', 'term': 'Amlodipine, Valsartan Drug Combination'}, {'id': 'D000068756', 'term': 'Valsartan'}, {'id': 'C436283', 'term': 'telmisartan, hydrochlorothiazide drug combination'}, {'id': 'D000077333', 'term': 'Telmisartan'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D014633', 'term': 'Valine'}, {'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'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': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D049971', 'term': 'Thiazides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-09', 'studyFirstSubmitDate': '2013-03-15', 'studyFirstSubmitQcDate': '2013-03-24', 'lastUpdatePostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the glucose change', 'timeFrame': 'To assess the change from baseline (week 0) to study endpoint (week 24) on 2hr-post-prandial plasma glucose level using oral glucose tolerance test (75-g OGTT)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'Recent studies have demonstrated that RAS inhibitors/calcium channel blockers are superior to RAS inhibitors/diuretics for reducing cardiovascular outcomes in hypertension. As such, RAS inhibitors/calcium channel blockers are recommended as first line combination treatment for hypertension. However, the mechanism for the superior efficacy of RAS inhibitors/calcium channel blockers are not well defined. This study will compare the efficacy of RAS inhibitors/calcium channel blockers vs RAS inhibitors/diuretics in terms of glucose tolerance and insulin resistance in hypertensive patients with metabolic syndrome. The primary endpoint will be that RAS inhibitors/calcium channel blockers will be more efficacious in reducing 2hour post prandial glucose compared to RAS inhibitors/diuretics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* consent to the study\n* Male or Female ≥ 20 years\n* Patients taking less than 1 antihypertensive medications or not taking antihypertensive medications. Hypertension defined at the screening visit as follows): 140mmHg \\< MSSBP or MSDBP \\> 90mmHg at screening\n* Hypertensive patients with non diabetic metabolic syndrome will be enrolled. Metabolic syndrome is defined according to NCEP guideline. (3 or more than) ① Abdominal obesity: Waist circumference M ≥ 90cm, F ≥ 80cm\n\n ② Hypertriglyceridaemia: Triglycerides ≥ 150mg/dL\n\n ③ Low HDL cholesterol Men: HDL cholesterol ≤ 40mg/dL Women: HDL cholesterol ≤ 50mg/dL\n\n ④ Elevated blood pressure (systolic blood pressure ≥ 130 mmHg and diastolic blood pressure ≥ 85 mmHg, or current use of antihypertensive drugs)\n\n ⑤ Impaired fasting glucose: fasting plasma glucose ≥ 100 mg/dL\n* Patient not taking statin medication and if the patient had ate statin medication the last duration must be before 3 months.\n\nExclusion Criteria:\n\n* • Women of child-bearing potential without a contraceptive measure\n\n * (Pregnant or nursing women\n * Known or suspected contraindications: history of allergy or hypersensitivity\n * History of clinically significant allergies including asthma and/or multiple drug allergies\n * Patients taking more than 2 antihypertensive medications\n * Patient taking statin medication and taking statin within 3 months\n * MSSBP \\> 180 mmHg or MSDBP \\> 110 mmHg at any time during the study\n * Evidence of a secondary form of hypertension)\n * History of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, myocardial infarction, percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) for 12 months prior to Visit 1\n * History of heart failure Grade II - IV according to the NYHA classification\n * Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia\n * Concomitant unstable angina pectoris\n * Clinically significant valvular heart disease\n * Patients with Type 1 or Type 2 diabetes mellitus\n * Evidence of hepatic disease as determined by one of the following: AST or ALT values ≥ 3 x UNL, a history of hepatic encephalopathy, history of esophageal varices, or history of portocaval shunt\n * Evidence of renal impairment as determined by one of the following: serum creatinine \\>2mg/dL , history of dialysis, or history of nephrotic syndrome\n * Protein in U/A values 2+ ≤\n * Serum potassium values \\< 3.2 or \\> 5.2 mmol/L\n * History of malignancy of any organ system within the past 5 years, treated or untreated, including leukemia and lymphoma, as further defined in the full protocol\n * Chronic use of NSAIDs\n * Use of cyclooxygenase-2 inhibitors (COX-2 inhibitors\n * Use of niacin \\> 100 mg/d\n * Use of loop diuretics\n * Use of statin shorter than 3 months\n * Inability to discontinue prior antihypertensive drugs as specified in the full protocol\n * persons directly involved in the execution of this protocol\n * Volume depletion based on the investigator's clinical judgment using vital signs, skin turgor, moistness of mucous membranes, and laboratory values\n * Any severe, life-threatening disease within the past five years"}, 'identificationModule': {'nctId': 'NCT01819220', 'briefTitle': 'Randomized, Open Labeled Clinical Trial to Compare the Effectiveness of Amlodipine/Valsartan vs Hydrochlorothiazide/Telmisartan on Glucose Tolerance in Patients With Hypertension With Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2009-0077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'amlodipine/valsartan', 'interventionNames': ['Drug: amlodipine/valsartan']}, {'type': 'EXPERIMENTAL', 'label': 'hydrochlorothiazide/telmisartan', 'interventionNames': ['Drug: hydrochlorothiazide/telmisartan']}], 'interventions': [{'name': 'amlodipine/valsartan', 'type': 'DRUG', 'otherNames': ['Starting dose of amlodipine 5mg/ valsartan 80mg'], 'description': 'This is a phase IV clinical study. The study is a 24 week, prospective, randomized open labeled multicenter study to compare the efficacy of amlodipine/valsartan combination vs telmisartan/hydrochlorothiazide combination in reducing post prandial sugar. The study will be performed in hypertensive patients with metabolic syndrome.\n\nActive group: Starting dose of amlodipine 5mg/ valsartan 80mg comparator group: Telmisartan 40mg/hydrochlorothiazide 12.5mg When the blood pressure is above the target goal of 140/90mmHg, up titration to amlodipine 5/valsartan 160 and/or telmisartan 80/hydrochlorothiazide 12.5mg is allowed.\n\nWhen the blood pressure is above 140/90mmhg at the 12th week, addition of doxazosin 4mg is allowed.', 'armGroupLabels': ['amlodipine/valsartan']}, {'name': 'hydrochlorothiazide/telmisartan', 'type': 'DRUG', 'otherNames': ['Telmisartan 40mg/hydrochlorothiazide 12.5mg'], 'description': 'When the blood pressure is above the target goal of 140/90mmHg, uptitration to amlodipine 5/valsartan 160 and/or telmisartan 80/hydrochlorothiazide 12.5mg is allowed.\n\nWhen the blood pressure is above 140/90mmhg at the 12th week, addition of doxazosin 4mg is allowed.', 'armGroupLabels': ['hydrochlorothiazide/telmisartan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei universty medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}