NCT00110422已完成4 期
Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2005年11月最近更新:
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
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Change from baseline in insulin resistance(MatsudaIndex)Week16
研究概览
简要总结
The purpose of this clinical research study is to learn if irbesartan is superior to hydrochlorothiazide relative to effects on insulin sensitivity and glucose metabolism in hypertensive patients 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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be willing and able to provide written informed consent. Subjects must read, sign, and receive a copy of the informed consent prior to any study procedures, including withdrawal of any antihypertensive medication.
- •Males and females >= 18 years of age.
- •Uncontrolled hypertension defined as an average systolic blood pressure >= 140 mmHg and/or an average diastolic blood pressure >= 90 mmHg. This applies to both people not taking any blood pressure medications and people taking just one blood pressure medication.
- •Presenting at least 2 of the following:
- •High triglycerides;
- •Low HDL cholesterol;
- •Elevated fasting glucose.
排除标准
- •Women of child bearing potential who are not using adequate birth control.
- •Women who are pregnant or breastfeeding
- •Diabetics
- •Systolic blood pressure >= 180 mmHg.
- •Diastolic blood pressure >= 110 mmHg.
- •Stroke within past 12 months.
- •Myocardial infarction and heart revascularization procedure or acute angina within past 6 months.
- •Moderate to severe heart failure.
- •Significant kidney or liver disease.
- •Cancer in past 5 years.
- •Drug or alcohol abuse.
研究组 & 干预措施
A1
Experimental
干预措施: Irbesartan (Drug)
B1
Active Comparator
干预措施: Hydrochlorothiazide (Drug)
结局指标
主要结局
Change from baseline in insulin resistance(MatsudaIndex)Week16
次要结局
- Change from baseline in insulin resist-QuickiIndex Week16;Change from baseline in triglyc.,BP,hs-CRP,albumin/creatinine ratio Week16;Changes from baseline-Matsuda,QuickiIndex,BP,triglyc.,hs-CRP&albumin/creatinine ratio Week28
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive PatientsHypertensionNCT00670566Sanofi503
已完成
3 期
Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe HypertensionHypertensionNCT00095394Bristol-Myers Squibb645
已完成
4 期
ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide CombinationHypertensionNCT00708344Sanofi832
已完成
3 期
Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate HypertensionHypertensionNCT00095550Bristol-Myers Squibb496
已完成
4 期
Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate HypertensionHypertensionNCT00500604Sanofi1,617