Evaluation of efficacy and safety of fixed dose combination of rosuvastatin and fenofibrate in the treatment of primary hypercholesterolemia not adequately controlled with statin or fibrate monotherapy: an open-label, non-comparative, multi-centre trial.

Sun Pharmaceutical Industries Ltd.0 个研究点目标入组 100 人开始时间: 待定最近更新: 2021年11月24日

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•1.Male or female patients aged between 18 - 70 years.
•2.Patients with fasting plasma LDL concentrations 145 mg/dl and < 250 mg/dl (6.47 mmol/L) and fasting triglyceride levels 400 mg/dl (4.52 mmol/L).
•3.Patients who are not appropriately controlled with statin or fibrate therapy.
•4.Patients willing to give their informed consent

•1.Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
•2.Patients with known hypersensitivity rosuvastatin /fibrates.
•3.Patients with active liver disease or with unexplained persistent elevations of serum transaminase.
•4.Patients with renal impairment advanced, hypothyroidism, hepatic dysfunction, preexisting gall bladder disease.
•5.Patients with elevated CK and myopathy.
•6.Patients with unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.
•7.Patients on gemfibrozil treatment.

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