A comparative, randomized, open label, parallel group, and multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Rosuvastatin 10 mg plus Fenofibrate 160 mg tablet Vs Atorvastatin 10 mg plus Fenofibrate 160 mg Tablet in patients with dyslipidaemia.

Ajanta Pharma Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent
•2.Patient with LDL-cholesterol ≥ 145 mg/dl (3.75mmol/l) and ≤ 250 mg/dl (6.47mmol/l) and triglyceride ≤ 350 mg/dl 93.99 mmol/l)

•1.History of hypersensitivity to the study drug or similar class of drug.
•2.Significant history or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications.
•3.Pregnant or lactating women.
•4.Patients with serum creatinine greater than 2.5 mg/dl.
•5.Patients with raised SGPT and total bilirubin greater than 50% above the upper normal limits
•6.History of drug dependency, alcohol abuse, or serious neurological or psychological disease.
•7.Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study.
•8.Use of enzyme-modifying drugs within 30 days prior to day 1 of this study.
•9.Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study

发起方