NCT03532620Unknown4 期
A Multi-center, Open-label, Randomized, 12-month, Parallel-group, Non-inferiority Study to Compare the Hemoglobin A1C Metabolism of Pitavastatin Therapy Versus Atorvastatin in Chinese Patients With Prediabetes and Hypertension
Jun Tao13 个研究点 分布在 1 个国家目标入组 396 人开始时间: 2018年8月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 396
- 试验地点
- 13
- 主要终点
- Change from baseline in hemoglobin A1c levels
研究概览
简要总结
The primary purpose of this trial is to test the hypothesis that Pitavastatin treatment compared to Atorvastatin, in patients with dyslipidemia, prediabetes and hypertension, will have less adverse effect on Hemoglobin A1C (HbA1C), which represents long-term glucose metabolism.
详细描述
Within the 12 months of the study procedure, the 3rd month is what we called the "check point". At this point, participants' plasma LDL-C will be measured whether it reached individual standard or not. If the results didn't meet the particular LDL-C standard, the participants would be adjusted the drug dosage (pitavastatin 4mg/day, atorvastatin 40mg/day).
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old;
- •IFG: 5.6mmol/L (100mg/dl)≤FPG<7.0mmol/L (126mg/dl), or IGT: 7.8mmol/L (140mg/dl)≤OGTT 2-h PG<11.1mmol/L (200mg/dl), or HbA1C 5.7-6.4% (39-47mmol/mol);
- •2.6mmol/L (100mg/dl)≤LDL-C≤5.2mmol/L (200mg/dl), and TG<5.7mmol/L (500mg/dl);
- •130mmHg≤SBP<180mmHg, or 80mmHg≤DBP<110mmHg or ongoing anti-hypertensive therapy;
- •Patients volunteered for the study and signed informed consent.
排除标准
- •Past history of hypersensitivity to the study drug;
- •Diagnosed diabetes;
- •Severe liver disease (including ALT or AST≥2.5-fold the normal upper limit), biliary obstruction;
- •Ongoing treatment with cyclosporine within 2 weeks;
- •Renal dysfunction, including endogenous creatinine clearance male<120ml/min, female<105ml/min, serum creatinine≥2mg/dl (186umol/L), Renal function progressive decline, GFR<30ml•min-1•1.73m-2;
- •Diagnosed or past history of ASCVD (including ACS, SCAD, revascularization, ICM, ischemic stroke, TIA, PASD, etc.
- •SBP≥180mmHg, or DBP≥110mmHg;
- •Ongoing treatment with Beta blockers, Diuretic;
- •Secondary hypertension, including SAS, PA, RAS, pheochromocytoma, Cushing's syndrome, aorta diseases, drug induced hypertension;
- •Ongoing treatment with statins, fibrates, and/or cation exchange resins within 2 weeks;
- •Pancreatic disease;
- •History of gastrectomy, short bowel syndrome;
- •Ongoing hormone replacement therapy;
- •Diagnosed or suspected malignant tumor;
- •Familial hypercholesterolemia;
- •Any diseases may limit the efficacy or safety of the study;
- •Pregnant or possibly pregnant woman, or breastfeeding woman, or woman who wishes to become pregnant during study participation;
- •Patient who was not judged as eligible by the investigator/coinvestigator.
- •IFG impaired fast glucose, FPG fasting plasma glucose, IGT impaired glucose tolerance, OGTT oral glucose tolerance test, PG plasma glucose, HbA1C hemoglobin A1C, LDL-C low-density lipoprotein cholesterol, TG triglycerides, SBP systolic blood pressure, DBP diastolic blood pressure, ALT alanine aminotransferase, AST aspartate aminotransferase, GFR glomerular filtration rate, ASCVD arteriosclerotic cardiovascular disease, ACS acute coronary syndrome, SCAD stable coronary artery disease, ICM ischemic cardiomyopathy, TIA transient ischemic attack, PASD peripheral atherosclerotic disease, SAS sleep apnea syndrome, PA primary aldosteronism, RAS renal arterial stenosis
研究组 & 干预措施
pitavastatin
Experimental
Pitavastatin Calcium + lifestyle modification
干预措施: Pitavastatin Calcium (Drug)
atorvastatin
Active Comparator
Atorvastatin Calcium + lifestyle modification
干预措施: Atorvastatin Calcium (Drug)
结局指标
主要结局
Change from baseline in hemoglobin A1c levels
时间窗: Month 12
Change of HbA1C values at study initiation and study completion
次要结局
- Changes from baseline in OGTT-2h PG levels(Month 12)
- Proportion of subjects in LDL-C normalization state(Month 3 and 12)
- Changes from baseline in high-density lipoprotein cholesterol (HDL-C) levels(Month 12)
- Changes from baseline in triglycerides (TG) levels(Month 12)
- Change from baseline in blood pressure levels(Month 12)
- Changes from baseline in vascular endothelial function(Month 12)
- Changes from baseline in FPG levels(Month 12)
- Changes from baseline in total cholesterol (TC) levels(Month 12)
- Changes from baseline in inflammatory parameters(Month 12)
- Changes from baseline in left ventricular mass index(Month 12)
- Incidence of cardiovascular disease (CVD) events(Month 12)
- Changes from baseline in carotid intima-media thickness(Month 12)
研究者
Jun Tao
Director, Head of the Department of Hypertension and Cardiovascular Disease, Principal Investigator, Clinical Professor
First Affiliated Hospital, Sun Yat-Sen University
研究点 (13)
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