CTRI/2010/091/000003已完成4 期
A randomized double blind study to evaluate the lipid modifying, anti-inflammatory, antioxidant efficacy and tolerability of combination of atorvastatin and ezetimibe versus atorvastatin in patients with dyslipidemia
I0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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
- •Patient of either sex of age 18-70 years
- •- Fasting LDL-C > or = 100 mg/dl in patients with CHD or CHD risk equivalents (Diabetes mellitus/ Peripheral arterial disease/ Carotid artery disease/ Abdominal aortic aneurysm) or
- •Fasting LDL-C > or = 130 mg/dl in patients with > or = 2 major risk factors for development of CHD having 10-20% ten year absolute CHD risk and on therapeutic lifestyle changes (TLC) for 3 months
- •- Patient taking low dose atorvastatin (10 mg) OD or patient not taking any hypolipidemic drug
- •- Able to provide written informed consent
排除标准
- •- Fasting serum triglyceride (TG) level ≥350 mg/dl
- •- Medical history of systemic infection within 6 weeks of study initiation
- •- Medical history of unstable angina, myocardial infarction, heart failure or stroke within 3 months of the study
- •- Uncontrolled hypertension (systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg)
- •- Uncontrolled diabetes mellitus (FBS > 300 mg/dl in patients with diabetes)
- •- ALT and AST > 2 x upper limit of normal
- •- Impaired renal function (creatinine > or = 2.0 mg/dl)
- •- Suffering from malabsorption syndrome or inflammatory bowel disease
- •- Pregnancy/Lactation
- •- Alcoholism
- •- Patients on drugs that can increase the incidence of statin induced myopathy
- •- Patient on chronic anti-inflammatory or antioxidant drugs within 6 weeks of study initiation
研究者
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