NCT00443612已完成4 期
A Randomized, Open Label, Cross-over Comparative Study of Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension
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
- Sanofi
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Forearm vascular resistance
研究概览
简要总结
Primary:
- To compare the change in forearm vascular resistance following a 12-week regimen of irbesartan/hydrochlorothiazide versus irbesartan
- To assess changes of serum proinflammatory cytokine, markers of cardiovascular risks, oxidative stress and circulating adhesion molecule including thiobarbiturate acid reactive substances (TBARS), C-reactive protein (CRP), interleukin 6 (IL-6), and vascular cell adhesion molecule 1 (VCAM-1).
Secondary:
- To compare the reduction in office blood pressure following a 12-week regimen of irbesartan/hydrochlorothiazide versus irbesartan
- To compare the response rate (defined as office Systolic blood pressure(SBP)/diastolic blood pressure (DBP) reduce more than 10mmHg from baseline), and BP controlled rate (defined as SBP<140 mmHg and /or DBP<90 mmHg)
- To ascertain the safety and tolerability of irbesartan / hydrochlorothiazide versus irbesartan when administered once daily
- To determine whether angiotensin II type 1 (AT-1) receptor gene polymorphisms (including A1166C gene with about 4% of the minor allele frequency in Chinese population and other single nucleotide polymorphisms with a higher frequency of about 10% of minor allele) is related to reduction of BP
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild to moderate hypertension with office diastolic BP (DBP) 90-109 mmHg and/or systolic BP (SBP) 140-179 mmHg before entering each treatment
排除标准
- •females: who are pregnant or breast feeding
- •office DBP ≧ 110 mmHg or office SBP ≧ 180 mmHg
- •history of significant cardiovascular diseases which include: acute myocardial infarction within six months or any ischemic heart disease requiring medication, or cerebrovascular disease
- •history of significant renal diseases including: serum creatinine > 3.0 mg/dl, or creatinine clearance < 30 ml/min.
- •severe biliary cirrhosis and cholestasis
- •refractory hypokalemia, hypercalcemia
- •history of autoimmune disease, collagen vascular disease, multiple drug allergies, bronchospastic disease or other malignancies requiring current medication
- •hepatic disease as indicated by any of the following : Serum Glutamic Oxaloacetic Transaminase (SGOT) or Serum Glutamic Pyruvate Transaminase (SGPT) >3 x upper limit of normal, or serum bilirubin > 2 x upper limit of normal
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
- 12 weeks on treatment 1
- 2 week washout period
- 12 weeks on treatment 2
干预措施: Irbesartan/Hydrochlorothiazide (Drug)
1
Experimental
- 12 weeks on treatment 1
- 2 week washout period
- 12 weeks on treatment 2
干预措施: Irbesartan (Drug)
2
Experimental
- 12 weeks on treatment 2
- 2 week washout period
- 12 weeks on treatment 1
干预措施: Irbesartan/Hydrochlorothiazide (Drug)
2
Experimental
- 12 weeks on treatment 2
- 2 week washout period
- 12 weeks on treatment 1
干预措施: Irbesartan (Drug)
结局指标
主要结局
Forearm vascular resistance
时间窗: At baseline and end of study
Changes of serum TBARS, CRP, IL-6, and VCAM-1
时间窗: Throughout the study period
Office BP measurement of seated SBP and DBP
时间窗: At baseline and after 12-week treatment
Adverse events
时间窗: Throughout the study period
次要结局
- Office BP measurement of seated SBP and DBP(At baseline and after 12-week treatment)
研究者
研究点 (1)
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