NCT03474562已完成4 期
Effect of High-Dose Rosuvastatin Combined With Telmisartan or Amlodipine on Glucose Metabolism in Atherosclerotic Cardiovascular Disease (ASCVD) Patients With Impaired Fasting Glucose (IFG) and Hypertension: A Randomized, Open-Label, Parallel, Prospective Study
Yuhan Corporation4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年4月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Change from baseline to week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)
研究概览
简要总结
This study will evaluate the effect of high-dose rosuvastatin combined with telmisartan or amlodipine on glucose metabolism in ASCVD patients with impaired fasting glucose and hypertension.
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
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Aged 19 to 75 years
- •Patients with ASCVD requiring high-intensity statin therapy (in accordance with the clinical ASCVD diagnostic criteria in the 2013 ACC/AHA Guideline)
- •Coronary artery disease
- •acute coronary syndrome
- •history of myocardial infarction (MI)
- •stable or unstable angina
- •history of coronary revascularization
- •stroke or transient ischemic attack (TIA)
- •peripheral arterial disease, history of peripheral arterial revascularization
- •Those who are taking antihypertensive drugs, or SBP > 140mmHg or DBP > 90mmHg on the left side
- •High-risk group (except for gestational diabetes) who has not been diagnosed with diabetes before, and who falls under one of the following criteria:
- •impaired fasting glucose (IFG): 100-125 mg/dL (5.6-6.9 mmol/L)
- •impaired glucose tolerance (IGT): plasma blood glucose 140-199mg/dL (7.8 to 11.0 mmol/L) 2 hours after oral administration of glucose 75g
- •HbA1c: 5.7-6.4%
排除标准
- •Those who are treated with secondary hypertension or malignant hypertension
- •Uncontrollable diabetes with HbA1c ≥ 10%
- •Total cholesterol ≥ 300mg/dL
- •Fasting LDL-C ≤ 70 mg/dL
- •Fasting triglyceride ≥ 500 mg/dL
- •History of muscular disease or rhabdomyolysis due to use of statin
- •Hypersensitive to statin or ARBs
- •Contraindications stated in the SPC of telmisartan or rosuvastatin including the following:
- •severe renal disease (CrCL < 30mL/min: Cockcroft-gault formula or estimated GFR (MDRD) < 30mL/min/1.73m2)
- •ALT, AST > 3x ULN or history of active liver disease
- •CPK > 3x ULN
- •hyperkalemia with serum K > 5.5 mEq/l
- •Those who are participating in clinical trials of other investigational products
- •Those who cannot discontinue all other treatment for hypertension or hyperlipidemia than the investigational products, and concomitant medications and supplements that can affect the therapeutic effect of hypertension and hyperlipidemia during the trial period
- •Other than the above who is deemed to be ineligible to participate in the trial by investigator
研究组 & 干预措施
Duowell Tab
Experimental
Telmisartan 40mg/Rosuvastatin 20mg qd for 24 weeks
干预措施: Duowell® (Drug)
Monorova Tab + Amlopin Tab
Active Comparator
Rosuvastatin 20mg + Amlodipine 5mg qd for 24 weeks
干预措施: Monorova® + Amlopin® (Drug)
结局指标
主要结局
Change from baseline to week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)
时间窗: Baseline, Week 24
次要结局
- Change from baseline to week 12 and week 24 in insulin level(Baseline, Week 12, Week 24)
- Change from baseline to week 12 and week 24 in total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C)(Baseline, Week 12, Week 24)
- Change from baseline to week 12 and week 24 in HOMA-IR(Baseline, Week 12, Week 24)
- Change from baseline to week 12 and week 24 in hemoglobin A1c (HbA1c)(Baseline, Week 12, Week 24)
- Change from baseline to week 12 and week 24 in C-reactive protein (CRP)(Baseline, Week 12, Week 24)
- Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG)(Baseline, Week 12, Week 24)
- Change from baseline to week 12 and week 24 in homeostatic model assessment for β-cell function (HOMA-B)(Baseline, Week 12, Week 24)
研究者
研究点 (4)
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