CTRI/2010/091/000556尚未招募3 期
Evaluation of efficacy and safety of two antihyperlipidemics as an adjunctive therapy in patients of mixed dyslipidemia, who are already on treatment with statins: an open-label, comparative, multicentric study.
Fax: 631-656-10060 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
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.Male or Female patients aged between 18 to 70 years.
- •2.Patients with Fasting TG &≥ 150mg/dl, HDL-C < 40mg/dl for men and < 50mg/dl for women and LDL-C & ≥130mg/dl.
- •3.Patients who are already on statin for at least 4 weeks and not adequately controlled.
- •4.Patients willing to give their informed consent.
排除标准
- •1.Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
- •2.Patients with cardiovascular disease, type 1 diabetes mellitus.
- •3.Patients with significantly abnormal laboratory analysis of thyroid function.
- •4.Patients with severe renal impairment, including those receiving dialysis.
- •5.Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.
- •6.Patients with preexisting gallbladder disease.
- •7.Patients with hypersensitivity to fenofibric acid or statin.
- •8.Patients taking oral coumarin anticoagulant.
- •9.Patient on treatment cyclosporine, niacin (nicotinic acid), erythromycin, azole antifungals.
- •10.Patients taking antacid, Colestipol.
- •11.Patients on treatment of endogenous steroid hormones such as ketoconazole, spironolactone, and cimetidine
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