NCT00708344已完成4 期
Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination: A Comparison of Active and Usual Titration Regimen in the Treatment of Hypertensive Patients Insufficiently Controlled by Monotherapy
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
- 832
- 试验地点
- 1
- 主要终点
- Change in mean Systolic Blood Pressure
研究概览
简要总结
To compare the antihypertensive efficacy of the combination irbesartan/hydrochlorothiazide (HCTZ) using either a usual or an active elective titration regimen. The main efficacy criteria will be the change in mean Systolic Blood Pressure (SBP), measured at doctor's office with an automatic device, after a 10-week treatment period in hypertensive patients insufficiently controlled by monotherapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established essential hypertension treated for at least 4 weeks by one antihypertensive drug alone
- •With uncontrolled Blood Pressure (BP) defined as:
- •SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg in non diabetic patients
- •SBP ≥ 150 mmHg and/or DBP ≥ 90 mmHg in diabetic patients
排除标准
- •SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg at V1
- •Known or suspected causes of secondary hypertension
- •Patient with bilateral renal artery stenosis, renal artery stenosis in a solitary kidney; history of renal transplant or only has one functioning kidney
- •Associated cardiovascular conditions that prevent the patient from stopping the current antihypertensive drug (e.g.: Beta-blocker for angina, ACE-inhibitors for heart failure, etc...).
- •Known hypersensitivity to diuretics or sulphonamides or history of angioedema or cough related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used
- •Known contraindications to the study drugs:
- •Severe renal dysfunction (creatinine clearance <30ml/min)
- •Known hypokaliemia (< 3 mmol/L) , known hypercalcemia
- •Severe hepatic impairment, biliary cirrhosis, cholestasis
- •Inability to obtain a valid automatic BP measurement recording
- •Administration of any other investigational drug within 30 days prior to study entry and during the course of the study
- •Presence of any severe medical or psychological condition that, in the opinion of the investigator, indicate that participation in the study is not in the best interest of the subject.
- •Presence of any other conditions (e.g. geographic, social, etc) that would restrict or limit the subject participation for the duration of the study.
- •Pregnant or breast-feeding women
- •Women of childbearing potential not protected by effective contraceptive method of birth control
- •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
Group 1
Active Comparator
Usual elective titration regimen
干预措施: Irbesartan - Hydrochlorothiazide (Drug)
Group 2
Active Comparator
Active elective titration regimen
干预措施: Irbesartan - Hydrochlorothiazide (Drug)
结局指标
主要结局
Change in mean Systolic Blood Pressure
时间窗: between Visit 1 (Week 0) and Visit 4 (Week 10)
次要结局
- Change in mean Diastolic Blood Pressure(between Visit 1 (Week 0) and Visit 4 (Week 10))
研究者
研究点 (1)
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不适用
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