PER-115-08已完成未知
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
sanofi-aventis Recherche & Development,0 个研究点目标入组 0 人开始时间: 2008年11月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 80（—）
入选标准
- •Outpatients of male or female age> 18 years
- •Established essential hypertension treated for at least 4 weeks with an antihypertensive only {The fixed dose combination does not represent monotherapy)
- •With uncontrolled Blood Pressure (BP) defined as follows: SBP> 160 mm Hg and / or DBP> 100 mm Hg in non-diabetic patients, SBP> 150 mm Hg and / or DBP> 90 mm Hg in diabetic patients
- •Obtaining Informed Consent in writing signed before enrollment in the study
排除标准
- •SBP> 180 mm Hg and / or DBP> 110 mm Hg in VI
- •Known or suspected causes of secondary hypertension
- •Patient with bilateral renal artery stenosis, renal artery stenosis in solitary kidney; history of kidney transplant or having only one functional kidney
- •Associated cardiovascular conditions that prevent the patient from stopping the current antihypertensive drug (eg, beta-blocker for angina, ACE inhibitors for heart failure, etc ...)
- •Known hypersensitivity to diuretics or sulfonamides 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 <30 ml / min), Known hypokalemia (<3 mmol / L), known hypercalcemia, Severe hepatic impairment, biliary cirrhosis, cholestasis
- •Impossibility of obtaining valid automatic BP registration
- •Administration of any other drug under investigation within 30 days before enrollment and during the course of the study
- •Presence of any severe medical or psychological condition that, in the opinion of the researcher, indicates that participation in the study is not part of the best interests of the subject
- •Presence of any other condition (eg, geographic, social, etc.) that restricts or limits the participation of the subject throughout the study
- •Pregnant or breastfeeding women
- •Women with reproductive potential not protected by an effective birth control method of birth control
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4 期
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