NCT00234858已完成4 期
A Phase IV, Randomized, Open-Label, Active Controlled Study to Compare the Effects of Tarka® and Hyzaar® on Glucose Tolerance in Subjects With Metabolic Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 280
- 主要终点
- Oral Glucose Tolerance
研究概览
简要总结
The primary objective of this study is to determine whether impaired glucose tolerance is improved to a greater degree by Tarka than Hyzaar in subjects with metabolic syndrome
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metabolic syndrome
- •Fasting blood glucose between 100 mg/dL and 125 mg/dL
- •Hypertension
- •One additional criteria, Exclusion 1
排除标准
- •Subject has a current diagnosis of Type 1 or Type 2 diabetes mellitus.
- •Subject has a hypersensitivity to ACE inhibitor, ARB, CCB, clonidine, methyldopa, hydralazine, or thiazide diuretic medication.
研究组 & 干预措施
1
Active Comparator
干预措施: trandolapril/verapamil (Drug)
2
Active Comparator
干预措施: (Hyzaar) losartan/hydrochlorothiazide (Drug)
结局指标
主要结局
Oral Glucose Tolerance
时间窗: up to 1 year / 52 weeks
次要结局
- Changes in blood pressure (BP), pulse rate and BP control. HbA1c, insulin sensitivity, insulin release, albuminuria, lipid profile, AMBP, clinical safety labs and adverse events.(up to 1 year / 52 weeks)
研究者
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