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
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 13
- 主要终点
- Percentage change from baseline in LDL-C for each dose group and average reduction across dose groups.
研究概览
简要总结
This is a prospective, open-label, multi-center, post-marketingevaluation program to evaluate the lipid-altering efficacy and safety of Rosuvastatinin hyperlipidemia patients in routine clinical practice. Six hundred (600)patients who meet the entry criteria will be allocated to the rosuvastatinstart dose of 5mg, 10 mg or 20 mg based on the treating physician judgment consideringthe baseline LDL-Cholesterol levels, future cardiovascular risk, potential riskfor adverse reactions, and recommendations in the package insert (label).
Rosuvastatin at the chosen dose level will be administered oncedaily for a total duration of 8 weeks and lipid levels and safety andtolerability will be measured on completion of 4 weeks and 8 weeks of therapy.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •Patients must be willing to follow the Therapeutic Lifestyle Changes (TLC) diet or similar cholesterol-lowering diet for the duration of the evaluation program.
- •Able to provide written, voluntary informed consent and have accessibility to the site.
- •Should not have received any statin/hypolipidemic therapy in the preceding 3 months at entry into the evaluation program.
排除标准
- •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;
- •Use of any investigational drug or participation of any clinical study within 30 days prior to this evaluation program.
结局指标
主要结局
Percentage change from baseline in LDL-C for each dose group and average reduction across dose groups.
时间窗: 8 weeks
Percentage change from baseline in Total cholesterol, HDL-C and Triglycerides
时间窗: 8 weeks
次要结局
- Percentage of subjects achieving NCEP ATP III defined target levels in each dosage groups(8 weeks)
- Incidence and type of any clinical or laboratory adverse experiences.(8 weeks)