A prospective, open-label, multi-center, post-marketing study to evaluate the lipid altering efficacy and safety of approved dose ranges of Rosuvastatin in Indian patients in routine clinical practice - ROSUVEES

Ranbaxy Laboratories Limited0 个研究点目标入组 600 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Male or female subject in the age range of 18-65 years.
•2.Subjects with hyperlipidemia defined as fasting LDL cholesterol more than 130 mg/dL who require lipid altering therapy as judged by the treating physician.
•3. Patients must be willing to follow the Therapeutic Lifestyle Changes (TLC) diet or similar cholesterol-lowering diet for the duration of the evaluation program.
•4. Able to provide written, voluntary informed consent and have accessibility to the site.
•5. Should not have received any statin/hypolipidemic therapy in the preceding 3 months at entry into the evaluation program.

•1.Female subject of child bearing potential or male subject who has a partner of childbearing potential, who refuses to use a medically acceptable form of contraception throughout the evaluation program.
•2.Female subject who is pregnant or lactating.
•3.Known hypersensitivity to Rosuvastatin or components
•4.Active liver disease or hepatic dysfunction (defined by an ALT, AST concentration of greater than 1.5 times the upper limit of normal [ULN]),
•5.Subjects with renal impairment or at screening presents with serum creatine greater than 1.4 mg/dL.
•6.Serum CK concentrations of greater than 3 times the ULN
•7.Usage of concomitant medications known to affect the lipid profile or present a potential safety concern (eg, through drug interaction)
•8.Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with the assessments of safety or efficacy during the course of the evaluation, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, psychiatric, or hematological disease as determined by the clinical judgment of the investigator;
•9. Use of any investigational drug or participation of any clinical study within 30 days prior to this evaluation program.

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