CTRI/2010/091/000147已完成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.0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 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
- •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 patient
- •Patients 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
研究者
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