CTRI/2011/091/000057已完成3 期
A multicentre, comparative, controlled, open label, randomized, parallel-group, phase III study to evaluate the safety and efficacy of fixed dose combination containing rosuvastatin calcium with ezetimibe versus monotherapy in dyslipidemic patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biocon Ltd
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
- •?Male and female patients with hyper LDL cholesterolemia, aged 20-80 years (both years inclusive)
- •?Patients with LDL-C >=160 mg/dL and <250 mg/dL on fasting conditions
- •?Patients with hypercholesterolemia (with Non-HDL-C) who are above target goal according to NCEP-ATP III after 3 months of treatment with other conventional statin doses, e.g. simvastatin 10-40 mg.
- •?Patients who are willing to comply with all study requirements
- •?Females of childbearing potential should have a negative pregnancy test at the prestudy visit and agree to use contraception during the study
- •?Patients willing to give informed consent
排除标准
- •?Patients who are unlikely to comply with protocol requirements (e.g., non-cooperative behavior, inability to attend the required by the protocol visits).
- •?Patients who are currently participating or had participated in other interventional study for last 3 months prior to their enrolment.
- •?Women who are pregnant, breast feeding or have the intention of becoming pregnant during their participation in the study.
- •?Women of childbearing potential who are not using effective and medically acceptable methods of contraception.
- •?Patients who are meeting any of the contraindications of the study medication according to the approved Summary of Product Characteristics (SPC).
- •?Known CVD, triglycerides > 500 mg/dL, renal disease (serum creatinine levels > 1.6 mg/dL), hypothyroidism, liver disease (SGOT and/or SGPT levels > 3-fold upper limit of normal in more than 2 consecutive measurements), alcohol consumption > 3 drinks/day for men and > 2 drinks/day for women, and current or previous gout.
- •?Patients with diabetes will be included in the study if they are adequately controlled (HbA1c<7%) with one or 2 antidiabetic drugs (no change in their treatment will be made during the study period).
- •?Patients who are positive for HIV test
- •?Patients currently taking lipid-lowering drugs (other than statins at a conventional dose) or having stopped them less than 4 weeks before study entry will be excluded
- •?Patients currently undertaking drugs like Cyclosporine, Niacin, Fenofibrate, Gemfibrozil, Lopinavir (or other protease inhibitors) Coumarin anticoagulants, clarithromycin, erythromycin, ketoconazole and itraconazole
- •?Patients with abnormal Creatine kinase (CK) level
研究者
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