CTRI/2010/091/000147未知3 期
A multicentric, open label, randomized, comparative, parallel group, active controlled Phase III clinical trial of the safety and efficacy of Fixed dose combination of tablets of Rosuvastatin 5 mg and Fenofibrate 160mg with Rosuvastatin 5mg alone in patients with dyslipidemia
M/s. Ravenbhel Healthcare Pvt. Ltd.4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 待定
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- change from baseline values of LDL-C, serum triglycerides, HDL-C
研究概览
简要总结
This study is a multicentric, open label, randomized, comparative, parallel group, active controlled Phase III clinical trial of the efficacy and safety of FDC of tablets of Rosuvastatin 5 mg and Telmisartan 160 mg with Rosuvastatin 5mg alone in patients with dyslipidemia in 200 patients will be conducted in 4 centres in India
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
入选标准
- •Male and female outpatients between 18-75 tears of age.Patients having i.
- •LDL cholesterol>130mg/dl ,ii.Serum triglycerides > or equal to 150mg/dl and < or equal to 500mg/dl.Able to stop current statin therapy without risk to the patientPatients who are able to adequately maintain diary.Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved ICF.
排除标准
- •No willing to sign ICF, Hypersensitivity to statins, Serum triglyceride levels > 500mg/dl.Patients with hepatic disease, poorly controlled diabetes mellitus, patients familiar with muscular pain, myopathy.Stroke less than six months prior to informed consent.
- •pregnancy and lactation, history of pancreatitis.
结局指标
主要结局
change from baseline values of LDL-C, serum triglycerides, HDL-C
时间窗: 12 weeks
次要结局
- Achievement of target levels of total cholesterolnd LDL cholesterol, patient compliance
研究者
研究点 (4)
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