Evaluation of efficacy and safety of fixed dose combination of statin and cholecalciferol for the treatment of hyperlipidemia: a randomised, open label, comparative, multicenter study.

Sun Pharma Laboratories Limited0 个研究点目标入组 335 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 to 70 years with hyperlipidemia.
•2 Patients LDL level greater than or equal to 100 mg/dL with at least one risk factor OR LDL level greater than or equal to 130 mg/dL with no risk factor.
•3 Treatment-NaÃ¯ve Patients i.e., not currently on Statin or other Lipid lowering drugs or Vitamin D supplement.
•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.Patient whose serum level of Vitamin D3 <10 nmol/L.
•3.Patients with cardiovascular disease and/or type 1 diabetes mellitus.
•4.Patients with significantly abnormal laboratory analysis of thyroid function.
•5.Patients with severe renal impairment, including those receiving dialysis.
•6.Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.
•7.Patients with preexisting gallbladder disease.
•8.Patients who is taking seizure drugs.
•9.Patients who is taking steroids.
•10.Patients with hypersensitivity to statin.
•11.Patients taking oral coumarin anticoagulant.
•12.Patients with concurrent administration of fibric acid derivatives, lipid-modifying doses of niacin, cyclosporine, or strong CYP 3A4 inhibitors (e.g., clarithromycin, HIV protease inhibitors, and itraconazole).
•13.Patient with history of alcohol abuse.

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