CTRI/2010/091/006086已完成3 期
A RANDOMIZED, OPEN LABEL, MULTICENTRE, COMPARATIVE CLINICAL TRIAL OF IN-SUPR-001 IN COMPARISON TO MICRONISED FENOFIBRATE IN PATIENTS OF MIXED DYSLIPIDEMIA
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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
- •Mixed Dyslipidemic patients of either gender
- •1.Age of 18 to 70 (excluding both) years
- •2.serum triglyceride levels between 150 mg/dl and 500 mg/dl
- •3.who are prescribed statin in stable dose since minimum 8 weeks.
- •In case of female patients with child bearing potential: surgically sterile or using a medically accepted means of contraception with negative serum pregnancy test
排除标准
- •Patients with
- •1.Pregnany, lactating women or women of childbearing age who are not using an acceptable method of birth control.
- •2.Patients with serum Low Density Lipoprotein Cholesterol (LDL-C) >160 mg/dl
- •3.Patients with type 1 diabetes mellitus.
- •4.Patients with thyroid dysfunction.
- •5.Patients with active liver disease, including those with primary biliary cirrhosis or liver dysfunction: Liver enzymes more than 2.5 times upper normal limit.
- •6.Patients with preexisting gallbladder disease.
- •7.Patients with hypersensitivity to fenofibric acid or fenofibrate.
- •8.Patients taking oral coumarin anticoagulant.
- •9.Patients who are chronic alcoholic ( > 20 ml of alcohol/day)
- •10.Patient on treatment with cyclosporine, niacin (nicotinic acid), erythromycin, azole antifungals.
- •11.Patients taking antacid, Colestipol.
- •12.Patients on treatment of endogenous steroid hormones, ketoconazole, spironolactone, and cimetidine
- •13.Patients with renal dysfunction: Serum creatinine more than 1.5 times upper normal limit.
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