CTRI/2010/091/006138已完成3 期
Comparative Evaluation of Efficacy and Safety of Fixed Dose Combination of Atorvastatin and Hydroxychloroquine with Atorvastatin alone in Patients with Dyslipidemia
Ipca Laboratories Ltd Mumbai0 个研究点目标入组 328 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 328
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
- •Treatment naïve patients with primary dyslipidemia and CHD or CHD risk equivalent characterized by an LDL-C level greater than or equal to 130 and greater than or equal to 250 mg/dL (3.3 mmol/L- 6.46 mmol/L), and TG levels less than or equal to 400mg/dl(4.51 mmol/L)
- •- Patients receiving prior statin therapy for dyslipidemia ( Atorvastatin not more than 10 mg, simvastatin not more than 20 mg, lovastatin not more than 20 mg, pravastatin not more than 40 mg and rosuvastatin not more than 5 m with LDL-C grater than or equal to 250 mg/dl (3.3 mmol/L- 6.46 mmol/L), and TG levels greater than or equal to 150 mg/dL(1.69 mmol/L) and less than or equal to 400 mg/dL (4.51 mmol/L)
排除标准
- •-Patients with Type I diabetes.
- •-Patients with Type 2 diabetes characterized by HbA1c less than or equal to 9 .
- •- Patients with severe obesity or body mass index more than 35 kg/m square
- •-Patients with homozygous familial hypercholesterolemia.
- •-Patients with recent cardiovascular accident or myocardial. infarction stroke or has undergone coronary artery bypass surgery, percutaneous tranluminal coronary angioplasty or unstable or severe peripheral artery disease within the past 6 months.
- •-Patients who had any other illness for which hydroxychloroquine was indicated (such as rheumatoid arthritis, Systemic lupus erythomatosus (SLE), malaria etc).
- •- Patients with history of any retinopathy including diabetic retinopathy requiring laser therapy, evidence of an imminent need for retinal laser therapy, uncorrected visual acuityless than 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.
- •- Patients with history of myalgia , aplastic anemia or agranulocytosis, granulocytopenia, psoriasis, porphyria, rash, scaling, scaling eczema and G6PD deficiency
- •- Patients with chronic use of non- steroidal anti inflamentry agents
- •- Patients receiving niacine and fibric acid derivatives
- •- Patients with abnormal renal and liver function test
- •- Patients receiving non selective beta blocker
- •- Patients with disease of blood or haematopoetic organs
- •-Patients with tuberculosis, terminal cancer, severe dementia, or subjects with history of concomitant infection that could interfere with evaluation.
- •-Woman of childbearing potential who do not agree to practice an effective method of birth control until one month following study completion.
- •-Lactating woman and postmenopausal woman on hormone replacement therapy.
研究者
相似试验
进行中（未招募）
3 期
Comparative Efficacy, Safety and Tolerability of Fixed Dose Combination of Cephalexin Extended Release (375 mg) and Clavulanate Potassium (125 mg) Tablets with Cephalexin Extended Release (375 mg) Tablets in the Treatment of Uncomplicated Skin and Soft Tissue InfectioCTRI/2015/01/005361Sun Pharmaceutical Industires Ltd180
进行中（未招募）
3 期
Fixed Dose Combination of Cephalexin Extended Release (375 mg) and Clavulanate Potassium (125 mg) Tablets in the Treatment of Upper Respiratory Tract Infections.CTRI/2015/01/005353Sun Pharmaceutical Industries limited180
尚未招募
3 期
Comparative study of the efficacy and safety of FormoterolCTRI/2017/03/008277Rus Biopharm LLC136
尚未招募
2 期
Comparison of the effect of Tulsi and Chlorhexidine mouth rinse on gum disease in controlled sugar patients aged 45-55 years in Davangere city.CTRI/2019/01/016960il
已完成
3 期
Comparative study of the efficacy and safety of intrathecal hyperbaric ropivacaine with hyperbaric bupivacaine in patients undergoing caesarean section under spinal anaesthesiaCTRI/2023/06/054563Pt B D Sharma University of Health Sciences PGIMS Rohtak Haryana90