NCT01819220已完成4 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To assess the glucose change
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •consent to the study
- •Male or Female ≥ 20 years
- •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
- •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
- •② Hypertriglyceridaemia: Triglycerides ≥ 150mg/dL
- •③ Low HDL cholesterol Men: HDL cholesterol ≤ 40mg/dL Women: HDL cholesterol ≤ 50mg/dL
- •④ Elevated blood pressure (systolic blood pressure ≥ 130 mmHg and diastolic blood pressure ≥ 85 mmHg, or current use of antihypertensive drugs)
- •⑤ Impaired fasting glucose: fasting plasma glucose ≥ 100 mg/dL
- •Patient not taking statin medication and if the patient had ate statin medication the last duration must be before 3 months.
排除标准
- •• Women of child-bearing potential without a contraceptive measure
- •(Pregnant or nursing women
- •Known or suspected contraindications: history of allergy or hypersensitivity
- •History of clinically significant allergies including asthma and/or multiple drug allergies
- •Patients taking more than 2 antihypertensive medications
- •Patient taking statin medication and taking statin within 3 months
- •MSSBP > 180 mmHg or MSDBP > 110 mmHg at any time during the study
- •Evidence of a secondary form of hypertension)
- •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
- •History of heart failure Grade II - IV according to the NYHA classification
- •Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia
- •Concomitant unstable angina pectoris
- •Clinically significant valvular heart disease
- •Patients with Type 1 or Type 2 diabetes mellitus
- •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
- •Evidence of renal impairment as determined by one of the following: serum creatinine >2mg/dL , history of dialysis, or history of nephrotic syndrome
- •Protein in U/A values 2+ ≤
- •Serum potassium values < 3.2 or > 5.2 mmol/L
- •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
- •Chronic use of NSAIDs
- •Use of cyclooxygenase-2 inhibitors (COX-2 inhibitors
- •Use of niacin > 100 mg/d
- •Use of loop diuretics
- •Use of statin shorter than 3 months
- •Inability to discontinue prior antihypertensive drugs as specified in the full protocol
- •persons directly involved in the execution of this protocol
- •Volume depletion based on the investigator's clinical judgment using vital signs, skin turgor, moistness of mucous membranes, and laboratory values
- •Any severe, life-threatening disease within the past five years
研究组 & 干预措施
amlodipine/valsartan
Active Comparator
干预措施: amlodipine/valsartan (Drug)
hydrochlorothiazide/telmisartan
Experimental
干预措施: hydrochlorothiazide/telmisartan (Drug)
结局指标
主要结局
To assess the glucose change
时间窗: 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)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
3 期
Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)PDACPDAC - Pancreatic Ductal AdenocarcinomaPancreatic CancerNCT06625320Revolution Medicines, Inc.500
已完成
3 期
Comparison of the safety and efficacy of Razi SARS-CoV-2 recombinant Spike protein (Razi Cov Pars) and Sinopharm vaccinesAcute Respiratory Distress Syndrome due to SARS-CoV-2.COVID-19, virus identifiedU07.1IRCT20201214049709N3Razi Vaccine and Serum Research Institute41,128
终止
3 期
Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal CancerMetastatic Colorectal CancerNCT05223673Institut de Recherches Internationales Servier7
已完成
2 期
TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATERheumatoid ArthritisNCT04413617Pfizer460
已完成
4 期
Efficacy and Safety of Alfacalcidol Compared to Calcitriol for Treatment of Secondary HyperparathyroidismSecondary HyperparathyroidismEnd Stage Renal DiseaseNCT01115543Mahidol University32