A Randomized, Double-Blind, Multi-Center Study Comparing the Effects of Carvedilol Phosphate Modified Release Formulation (COREG- MR) With Metoprolol Succinate (TOPROL XL) on the Lipid Profile in Normolipidemic, or Mildly Dyslipidemic Hypertensive Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 514
- 试验地点
- 1
- 主要终点
- Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Levels by Treatment Group at Maintenance Month 6
研究概览
简要总结
This study was designed to determine whether treatment with COREG MR is more effective at maintaining a better lipid profile than treatment with TOPROL-XL for hypertension.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented history of hypertension
- •Triglycerides of 120-400 mg/mL
- •LDLc levels not requiring lipid lowering medication.
排除标准
- •Has known contraindication to alpha- or beta-blocker therapy.
- •Has taken any non-ocular beta-blockers within three months before screening.
- •Has Type I or II diabetes.
- •Taking lipid lowering medications.
研究组 & 干预措施
Carvedilol Phosphate modified release formulation
干预措施: Carvedilol Phosphate modified release formulation (Drug)
metoprolol succinate
干预措施: metoprolol succinate (Drug)
结局指标
主要结局
Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Levels by Treatment Group at Maintenance Month 6
时间窗: Baseline and Month 6
Blood draw for HDL-C levels. Full beta Quant test performed with HDL subclasses. Change = Month 6 value minus Baseline value.
Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance Month 6
时间窗: Baseline and Month 6
Blood draw for triglyceride levels. Full beta quantification test performed which uses ultracentrifugation to partially separate lipoprotein classes and is the basis for the reference methods. Change = Month 6 value minus Baseline value.
次要结局
- Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6(Baseline and Month 6)
- Change From Baseline in Fasting Insulin (Glycemic Parameter) by Treatment Group at Maintenance Month 6(Baseline and Month 6)
- Change From Baseline in Hemoglobin A1c (HbA1c) (Glycemic Parameter) by Treatment Group at Maintenance Month 6(Baseline and Month 6)
- Change From Baseline in c-Peptide (Glycemic Parameter) by Treatment Group at Maintenance Month 6(Baseline and Month 6)
- Change From Baseline in Homeostasis Model Assessment (Glycemic Parameter) by Treatment Group at Maintenance Month 6(Baseline and Month 6)
- Change From Baseline in Fasting Plasma Glucose (FPG) (Glycemic Parameter) by Treatment Group at Maintenance Month 6(Baseline and Month 6)
- Change From Baseline in Log Transformed High Sensitivity C-reactive Protein (Hs-CRP) by Treatment Group at Maintenance Month 6(Baseline and Month 6)
- Change From Baseline in Blood Pressure by Treatment Group at Maintenance Month 6(Baseline and Month 6)
- Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of g/L at Maintenance Month 6(Baseline and Month 6)
- Change From Baseline in Heart Rate by Treatment Group at Maintenance Month 6(Baseline and Month 6)
- Change From Baseline in Weight by Treatment Group at Maintenance Month(Baseline and Month 6)
- Change From Baseline in Log Transformed Lipoprotein-associated Phospholipase A2 (LpPLA2) by Treatment Group at Maintenance Month 6(Baseline and Month 6)