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
- 试验地点
- 3
- 主要终点
- Percentage changes from baseline levels of LDL-C with fixed dose combination of rosuvastatin calcium (5/10/20 mg) with ezetimibe 10 mg vs. monotherapy with rosuvastatin calcium 10 mg vs. ezetimibe 10 mg after 4 weeks of therapy
研究概览
简要总结
This study is a multicentric, comparative, open label, randomized, parallel-group, phase III study. The primary objective is to asses and compare the LDL-C lowering efficacy of fixed dose combinations of rosuvastatin calcium (5/10/20 mg) and ezetimibe 10 mg in comparison with rosuvastatin calcium10 mg or ezetimibe 10 mg, monotherapy, after 4 Weeks of treatment. Secondary objective would be to assess and compare the effects of FDC of rosuvastatin calcium (5/10/20 mg) with ezetimibe 10 mg vs. monotherapy of these drugs on percentage change in HDL-C, TC, TG, non-HDL-C, TC/HDL-C, LDL-C/HDL-C and nonHDL-C/HDL-C from baseline after 4 weeks of therapy and also to assess the safety and tolerability of FDC of rosuvastatin calcium (5/10/20 mg) in combination with ezetimibe 10 mg vs. rosuvastatin calcium 10 mg vs. ezetimibe 10 mg after 4 weeks of treatment. This study is sponsored by Biocon with three centers across india. The study will recruit 200 patients from India.
研究设计
- 分配方式
- Stratified randomization
- 盲法
- Open Label
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.
结局指标
主要结局
Percentage changes from baseline levels of LDL-C with fixed dose combination of rosuvastatin calcium (5/10/20 mg) with ezetimibe 10 mg vs. monotherapy with rosuvastatin calcium 10 mg vs. ezetimibe 10 mg after 4 weeks of therapy
时间窗: 4 weeks treatment
次要结局
- The percentage change in HDL-C, TC and fasting TG levels from the therapy initiation (baseline values) to the levels at the end of 4 weeks of the study.(4 Weeks treatment)
- The percentage of patients treated with FDC of rosuvastatin calcium (20/10/5 mg) with ezetimibe 10 mg vs. monotherapy of these drugs achieving LDL-C levels recommended by NCEP/ATP III, after 4 weeks of therapy.(4 Weeks treatment)