CTRI/2017/12/010763尚未招募3 期
Efficacy and Safety of hydroxycholorquine and atorvastatin combination in prevention of diabetes in patients with dyslipidemia and pre diabetes: A double blind, randomized comparison with atovastatin alone
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 992
- 试验地点
- 31
- 主要终点
- Patients developing diabetes (HbA1c ≥ 6.5%)
研究概览
简要总结
The primary purpose of this study is to compare the hydroxycholoroquine 300 mg and atorvastatin 20 mg tablet with atorvastatin 20 mg tablet alone in prevention of diabetes in patients with dylipidemia and pre diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with primary dyslipidemia (LDL-C level ≥ 130 mg/dL and/or TG levels ≥150 mg/dL and ≤ 400 mg/dL).
- •Patients having HbA1c between 5.7% and 6.4% 3) Patients with body weight > 60 kg 4) Patients able to understand and willing to fully comply with study procedures and restrictions 5) Patient ready to give written informed consent as per applicable regulatory requirements.
排除标准
- •Patients with Type 1 or Type 2 diabetes 2) Patients with a history or presence of any retinopathy of any grade including diabetic retinopathy requiring laser therapy, evidence of an imminent need for retinal laser therapy, uncorrected visual acuity <20/100, abnormal visual fields, difficulty to examine optic disc, or evidence of retinal pigment epithelial abnormalities and patients with history or risk of macular edema 3) Patients with abnormal renal function (eGFR <60 mL/min/1.73m2) 4) Patients with abnormal liver function (AST and ALT, total bilirubin, creatine phosphokinase or alkaline phosphatase >2.5 times the upper limit of normal values) 5) Patients with cardiovascular accident or myocardial infarction, stroke or has undergone coronary artery bypass surgery, percutaneous transluminal coronary angioplasty or transient ischemic attack, or history of congestive heart failure, or unstable angina or edema of any type in past 6) Patients with history of myalgia, aplastic anemia or agranulocytosis, granulocytopenia, psoriasis, porphyria, rash, scaling, scaling eczema, and G6PD deficiency 7) Patient with history of symptomatic autonomic neuropathy 8) Patients with disease of blood or haematopoetic organs or hemoglobin< 11g/dL for female patient or hemoglobin< 13 g/dL for male patient 9) Patients with systolic BP > 180 mm Hg and/or diastolic BP >110 mmHg 10) Patients with chronic gastroparesis, active gastrointestinal disorders (gastric and duodenal ulcer) 11) Patient who had any other illness for which hydroxychloroquine was indicated (such as rheumatoid arthritis, SLE).
- •Patients with known history of HIV1/HIV2/Hepatitis B or C infection or syphilis infection 13) Patients with any other clinically significant abnormality (ies) interfering with disease under evaluation.
结局指标
主要结局
Patients developing diabetes (HbA1c ≥ 6.5%)
时间窗: Within 52 weeks
次要结局
- Percentage change in low-density lipoprotein cholesterol((LDL-C), total cholesterol (TC), triglycerides (TG), high-density lipoprotein)
研究者
研究点 (31)
Loading locations...
相似试验
已完成
不适用
Statins in Patients With Type 2 Diabetes Mellitus and Previous History of Acute Coronary SyndromeHydroxymethylglutaryl-CoA Reductase InhibitorsDiabetes MellitusNCT05306990Helwan University108
已完成
3 期
Lornoxicam Versus Etoricoxib in Postoperative Pain After Total Knee ArthroplastyPostoperative PainNCT02750917Foisor Orthopedics Clinical Hospital120
已完成
4 期
Efficacy and Safety of Arotinolol Hydrochloride on Morning Blood Pressure and Heart RateEssential HypertensionNCT02612298Sumitomo Pharma (Suzhou) Co., Ltd.198
Unknown
4 期
High Dose Atorvastatin for Preventing Periprocedural Ischemic Brain Damage During Carotid Artery StentingCarotid Artery StenosisNCT03079115Beijing Hospital130
已完成
不适用
effect of high dose of atorvastatin after angioplasty in patients with stable anginastable angina.Chronic ischaemic heart diseaseIRCT2016060418741N2Mazandaran University of Medical Sciences469