NCT05107063已完成不适用
A Multi-center, Prospective Observational Study to Investigate the Effectiveness of Pravastatin on Renal Function in Korean Dyslipidemic Patients With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,972
- 试验地点
- 47
- 主要终点
- Percentage Change Rate From Baseline in the Modification of Diet in Renal Disease(MDRD) Estimated Glomerular Filtration Rate (eGFR) at Week 24 After Routine Care of Pravastatin Administration
研究概览
简要总结
This study investigated the effectiveness of pravastatin on renal function in Korean dyslipidemic patients with Type 2 diabetes.
详细描述
This survey study investigated the effect of routine initiation single dose of pravastatin (10 mg, 20 mg, or 40 mg) on renal function in Korean dyslipidemic patients with Type 2 diabetes. The study also examined the effect of pravastatin on lipid profiles, glucose metabolism, and safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with Type 2 diabetes (currently using an antidiabetic drug or satisfying diagnostic criteria of diabetes as defined by American Diabetes Association)
- •Participants with dyslipidemia (currently using an antidyslipidemic drug or satisfying the Health Insurance Review & Assessment Service insurance coverage treatment criteria*) for whom drug treatment with pravastatin is confirmed
- •Participants determined to be eligible as subjects at the discretion of the investigator
- •Participants who voluntarily provided written consent using the Informed Consent Form on Use of Information
排除标准
- •Participants who had administered pravastatin prior to study participation
- •Participants with hypersensitivity to the investigational product or its history
- •Participants with an active liver disease or persistent elevation of transaminase with an unknown cause
- •Pregnant woman or women with childbearing potential, breastfeeding mothers
- •Participants with severe hepatic or renal insufficiency
- •Participants with myopathy
- •Participants with cholestasis
- •Participants with hypercholesterolemia due to hyperalphalipoproteinemia accompanied by HDL cholesterol elevation
- •Participants with a genetic problem such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
研究组 & 干预措施
Dyslipidemic participants with Type 2 diabetes
Dyslipidemic participants with Type 2 diabetes who received a routine initiation dose of pravastatin 10 mg, 20 mg or 40 mg single dose once daily and maintained a low cholesterol diet throughout the study period.
干预措施: Pravastatin (Drug)
结局指标
主要结局
Percentage Change Rate From Baseline in the Modification of Diet in Renal Disease(MDRD) Estimated Glomerular Filtration Rate (eGFR) at Week 24 After Routine Care of Pravastatin Administration
时间窗: Week 24 post-dose
The following formula was used to calculate MDRD eGFR: MDRD eGFR (mL/min/1.73 m\^2) = 186 x (serum creatinine) -1.154 x (age)-0.203 x (0.742 if female)
次要结局
- Percentage Change Rate from Baseline in Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR) at Week 12 and Week 48 After Routine Care of Pravastatin Administration(Week 12 and Week 48 post-dose)
- Change from Baseline in Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR) at Week 24 After Routine Care of Pravastatin Administration(Week 24 post-dose)
- Change from Baseline in Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR) at Week 12 and Week 48 after Routine Care of Pravastatin Administration(Week 12 and Week 48 post-dose)
- Percentage Change Rate from Baseline in Estimated Glomerular Filtration Rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration(CKD-EPI) Formula at Week 12, Week 24, and Week 48 After Routine Care of Pravastatin Administration(Week 12, Week 24, and Week 48 post-dose)
- Percentage Change Rate from Baseline in Total Cholesterol, Low Density Lipoprotein Cholesterol, High Density Lipoprotein-Cholesterol, Triglycerides, Fasting Plasma Glucose at Week 12, Week 24, and Week 48 After Routine Care of Pravastatin Administration(Week 12, Week 24, and Week 48 post-dose)
- Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration(CKD-EPI) Formula at Week 12, Week 24, and Week 48 After Routine Care of Pravastatin Administration(Week 12, Week 24, and Week 48 post-dose)
- Change from Baseline in Total Cholesterol, Low Density Lipoprotein Cholesterol, High Density Lipoprotein-Cholesterol, Triglycerides, Fasting Plasma Glucose at Week 12, Week 24, and Week 48 After Routine Care of Pravastatin Administration(Week 12, Week 24, and Week 48 post-dose)
- Percentage Change Rate from Baseline in Hemoglobin A1c (HbA1c) at Week 12, Week 24 and Week 48 After Routine Care of Pravastatin Administration(Week 12, Week 24, and Week 48 post-dose)
- Change from Baseline in Hemoglobin A1c (HbA1c) at Week 12, Week 24 and Week 48 After Routine Care of Pravastatin Administration(Week 12, Week 24, and Week 48 post-dose)
- Number of Participants With Treatment-emergent Adverse Events After Routine Care of Prevastatin Administration(Week 48 post-dose)
研究者
研究点 (47)
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