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临床试验/CTRI/2010/091/000556
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 &&#8805; 150mg/dl, HDL-C < 40mg/dl for men and < 50mg/dl for women and LDL-C & &#8805;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

研究者

发起方
Fax: 631-656-1006

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