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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) Patients with primary dyslipidemia (LDL-C level >= 130 mg/dL and/or TG levels >=150 mg/dL and <= 400 mg/dL).
- •2) 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
- •1) 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
- •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).
- •12) 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
研究者
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