NCT00328393已完成3 期
Effect of Pioglitazone on Ambulatory Blood Pressure
University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Median of systolic 24-hour ambulatory blood pressure
研究概览
简要总结
The anti-diabetic pioglitazone has been found to reduce casual blood pressure. To date, no data are available looking at this effect in detail. Especially, ambulatory blood pressure has not yet been utilized to confirm the hypothesis that pioglitazone has blood pressure lowering effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 45-75 years
- •Diabetes mellitus Type 2 (HbA1c 7 - 8.5%)
- •Casual blood pressure > = 130/80 mmHg, < 160/100 mmHg
排除标准
- •Therapy with insulin
- •Combination therapy of sulfonyl-urea und metformin
- •Therapy with nateglinid, repaglinid or an other substance of this drug family
- •Allergy against pioglitazone or other composites of the tablet
- •History of heart failure (NYHA I bis IV)
- •Hepatic insufficiency
- •Transaminases > 2.5-fold of the upper normal limit
- •End-stage renal failure
- •Syndrome of polycystic ovaries
- •Absence of effective contraception in women of childbearing potential
- •Pregnancy or breast-feeding
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Pioglitazone
Active Comparator
Pioglitazone 45 mg, 8 weeks
干预措施: Pioglitazone (Drug)
结局指标
主要结局
Median of systolic 24-hour ambulatory blood pressure
时间窗: 8 weeks
Change of 24-hour blood pressure after 8 weeks of treatment
次要结局
- Median of 24-hour diastolic ambulatory blood pressure(8 weeks)
研究者
研究点 (1)
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