A Study Comparing the Effects of Pitavastatin, Atorvastatin, and Rosuvastatin on Plasma Levels of CoQ10 (SPARQ)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Changes in Plasma CoQ10 Levels
研究概览
简要总结
The purpose of this study is to determine if Pitavastatin lowers CoQ10 less than Atorvastatin or Rosuvastatin.
详细描述
Statins are known effectively treat high cholesterol and heart disease. However, statins may lower endogenous levels of Coenzyme10 (CoQ10). This decrease in CoQ10 levels may be responsible for side effects such as myalgia.
Previous studies have shown that Pitavastatin may not affect CoQ10 levels as other statins do, while still lowering cholesterol.
In this study, investigators intend to compare the plasma levels of CoQ10 in patients taking 3 different FDA-approved statins, in equipotent doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LDL-C levels of 100-200mg/dl; triglycerides </=200mg/dl at screening visit
- •Willing to discontinue use of all lipid-altering doses fo medication or supplements for the duration of the study
排除标准
- •LDL-C <100mg/dl or >200mg/dl, Triglycerides >200mg/dl
- •History of diabetes mellitus or documented fasting blood glucose >125mg/dl or HbA1c >6.4%
- •History of coronary artery disease
- •history of chronic renal or hepatic disease
- •known sensitivity of intolerance to a statin
- •persistent elevated liver enzymes or CPK (>3 x upper normal limit)
- •currently taking CoQ10 supplements and unable discontinue for duration of study
研究组 & 干预措施
Pitavastatin 4mg
Pitavastatin 4mg tablet by mouth once daily for 12 weeks
干预措施: Atorvastatin 20mg (Drug)
Pitavastatin 4mg
Pitavastatin 4mg tablet by mouth once daily for 12 weeks
干预措施: Rosuvastatin 5mg (Drug)
Atorvastatin 20mg
Atorvastatin 20mg tablet by mouth once daily for 12 weeks
干预措施: Pitavastin 4mg (Drug)
Atorvastatin 20mg
Atorvastatin 20mg tablet by mouth once daily for 12 weeks
干预措施: Rosuvastatin 5mg (Drug)
rosuvastatin 5 mg
rosuvastatin 5 mg tablet by mouth once daily for 12 weeks
干预措施: Pitavastin 4mg (Drug)
rosuvastatin 5 mg
rosuvastatin 5 mg tablet by mouth once daily for 12 weeks
干预措施: Atorvastatin 20mg (Drug)
结局指标
主要结局
Changes in Plasma CoQ10 Levels
时间窗: Change from Baseline to 12 Weeks
Change in levels will be measured by taking difference between Baseline and Week 12 measures.
次要结局
- Changes in Major Lipid Parameters - VLDL Size(Change from Baseline to 12 Weeks)
- Changes to Glucose Metabolism - HbA1c and Insulin(Change from Baseline to 12 weeks)
- Changes in HDL and LDL Size(Change from Baseline to 12 Weeks)
- Changes to Glucose Metabolism - Fructosamine(Change from Baseline to 12 weeks)
- Changes HDL Particle Number and LDL Particle Number(Change from Baseline to 12 Weeks)
研究者
Patrick Moriarty, MD, FACP, FACC
Director, Atherosclerosis & LDL-Apheresis Center
University of Kansas Medical Center