NCT00264212已完成4 期
A Multicentre Prospective Randomized Open-Label 12-Week Study With Blinded Evaluation Comparing the Efficacy and Safety of Irbesartan and Irbesartan-Hydrochlorothiazide Fixed Combination With Amlodipine and Amlodipine Plus Hydrochlorothiazide in Elderly Patients With Isolated Systolic Hypertension
适应症
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
- 436
- 试验地点
- 8
- 主要终点
- Change from baseline in office seated SBP at week 12
研究概览
简要总结
To compare the antihypertensive efficacy and tolerability of irbesartan and irbesartan-hydrochlorothiazide fixed combination therapy with amlodipine and amlodipine plus hydrochlorothiazide in the treatment of isolated systolic hypertension.
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
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at Screening
- •Outpatients
- •With newly diagnosed and untreated OR previously diagnosed, treated and uncontrolled Isolated Systolic Hypertension defined as:
- •seated Systolic Blood Pressure (SBP) ≥ 160mmHg and < 220 mmHg [160-220[
- •AND seated Diastolic Blood Pressure (DBP)< 90 mmHg
- •at Randomization
- •Having completed the 2 to 4-week wash-out/placebo run-in phase
- •Still eligible for Blood Pressure
- •seated SBP ≥ 160mmHg and < 220 mmHg [160-220[
- •AND seated DBP < 90 mmHg.
- •Exclusion Criteria (at Screening):
- •Participation in a clinical trial within the previous 3 months
- •Patients with a history of irbesartan, amlodipine, or hydrochlorothiazide sensitivity defined as irbesartan, amlodipine, or hydrochlorothiazide discontinuation due to medically significant adverse effects
- •Patients currently or previously treated with Angiotensin II Receptor Blocker (irbesartan, losartan, candesartan, valsartan, telmisartan, etc.) or dihydropiridine Calcium Channel Blocker (amlodipine, nicardipine, felodipine, nifedipine, etc.) AND not responding despite maximum tolerated dose
- •Known or suspected secondary hypertension (e.g., coarctation of aorta, renovascular stenosis, etc.)
- •Known single functional kidney
- •History of recent myocardial infarction, coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty, or cerebrovascular accident (Transient Ischaemic Attack, stroke) within the last 6 months of study entry
- •Patients with known gastrointestinal, renal, hepatic, endocrine, cardiovascular, pulmonary, immunological or hematological disease which in the opinion of the investigator is active or uncontrolled
- •Patients with significant renal (clearance of creatinine < 30 mL/mn), hepatic or cardiac insufficiency, or known valvular heart disease
- •Serum potassium < 3.5 mmol/L (mEq/L) or > 5.5 mmol/L (mEq/L)
- •Presence of clinically significant ventricular or supraventricular arrhythmias, or second or third degree atrioventricular block, or QTc prolongation (Bazett > 450 msec.) on the ECG
- •Pregnancy or lactation. Women of child bearing potential (not post-menopausal) should be using a reliable contraceptive method
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
排除标准
- 未提供
结局指标
主要结局
Change from baseline in office seated SBP at week 12
次要结局
- At 4, 8 and 12 weeks: Number of responders and normalized, Change from baseline in pulse pressure (SBP-DBP), Change from baseline in standing SBP, Safety : Change in standing SBP/DBP, incidence of orthostatic hypotension, adverse events
研究者
研究点 (8)
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