NCT00123903终止3 期
A Randomized, Double-blind, Positive-Controlled, Multicenter Study Comparing the Efficacy of Carvedilol Phosphate Modified Release Formulation (COREG MR) and Metoprolol Succinate Extended Release (TOPROL-XL) on the Reduction of Microalbuminuria in Patients With Hypertension and Microalbuminuria
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1,220
- 试验地点
- 94
- 主要终点
- Change from baseline in urine albumin: creatinine ratio (ACR) at six months of maintenance therapy.
研究概览
简要总结
This study was designed to determine whether COREG MR is more effective than TOPROL-XL in reducing microalbuminuria in type 2 diabetic or non-diabetic patients with high blood pressure and microalbuminuria.
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
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.
- •Must have been taking an ACE (angiotensin converting enzyme) inhibitor either alone or as part of an antihypertensive regimen for at least 8 weeks.
- •Persistent microalbuminuria.
排除标准
- •History of heart attack, stroke, congestive heart failure, arrhythmia, type 1 or uncontrolled type 2 diabetes mellitus, liver or renal disease.
- •Has been taking any non-ocular beta-blockers for any indication within three months prior to Pre-screening.
结局指标
主要结局
Change from baseline in urine albumin: creatinine ratio (ACR) at six months of maintenance therapy.
时间窗: Baseline (Randomization Visit) and Month 6
次要结局
- Percentage of participants who achieved normoalbuminuria at 6 months of maintenance therapy.(Month 6)
- Percentage of participants who progressed to macroalbuminuria after 6 months of maintenance therapy.(Month 6)
- Change from baseline to month 6 LOCF in High-sensitivity C-reactive protein (hs-CRP)(Baseline (Randomization Visit) and Month 6)
- Change from Pre-screening visit to month 6 LOCF in urine ACR.(Pre-screening Visit and Month 6)
- Change from baseline to visit to month 6 LOCF in lipids including total cholesterol, low density lipid (LDL), high density lipid (HDL) and Triglycerides (TG)(Baseline (Randomization visit) and Month 6)
- Changes from baseline in blood pressure (systolic and diastolic) at month 6 of treatment.(Baseline (Randomization Visit) and Month 6)
- Changes from baseline in heart rate at month 6 of treatment.(Baseline (Randomization visit) and Month 6)
- Percentage of participants who required add-on therapy to reach target blood pressure at any time during the study.(Up to 6 months)
- Number of participants with clinical chemistry parameters and hematology parameters of potential clinical concern at any time on-treatment.(Up to 6 months)
- Number of participants with vital signs of potential clinical concern at any time on-treatment.(Up to 6 months)
研究者
研究点 (94)
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