EUCTR2005-005010-20-BE进行中（未招募）1 期
A double-blind, randomized, multicenter study to evaluate the effectiveness of the combination of valsartan and amlodipine in hypertensive patients not controlled on monotherapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Male or female patients =18 years of age
- •2.Non-diabetic patients must have MSSBP of =140 mmHg and/or MSDBP =90 mmHg at Visits 1 and 2. Diabetic patients must have MSSBP =130 mmHg and/or MSDBP =80 mmHg at Visits 1 and 2
- •3.Patients treated with monotherapy at a dose considered as adequate by the investigator for a minimum of two months prior to Visit 1
- •4.Written informed consent to participate in the study prior to any study procedures
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Known or suspected contraindications, including history of allergy to ARBs, CCB, thiazides or to drugs with similar chemical structure
- •2.MSSBP =180 mmHg and/or MSDBP =110 mmHg (MSSBP =160 mmHg and/or MSDBP =100 mmHg for diabetic patients) at any time between Visit 1 and Visit 2.
- •3.Evidence of a secondary form of hypertension, to include coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, or pheochromocytoma
- •4.Known Keith-Wagener grade III or IV hypertensive retinopathy
- •5.History of hypertensive encephalopathy, cerebrovascular accident or myocardial infarction
- •6.History of transient ischemic attack 12 months prior to Visit 1
- •7.Percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) 12 months prior to Visit 1
- •8.Diabetes mellitus type 1
- •9.Poorly controlled type 2 diabetes mellitus, i.e. glycosylated hemoglobin (HbA1c) >8.0%
- •10.History of heart failure Grade II - IV according to the NYHA classification
- •11.Second or third degree heart block without a pacemaker
- •12.Concomitant unstable angina pectoris
- •13.Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia
- •14.Clinically significant valvular heart disease
- •15.Evidence of hepatic disease as determined by one of the following: ALT or AST values >3 x UNL at visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
- •16.Evidence of renal impairment as determined by one of the followings: serum creatinine >1.5 x UNL at visit 1, a history of dialysis, or a history of nephrotic syndrome
- •17.Serum sodium value < 135 mmol/L at visit 1
- •18.Serum potassium values <3.5 mmol/L or >5.5 mmol/L at visit 1
- •19.Any surgical or medical condition which might alter the absorption, distribution, metabolism, or excretion of any drug
- •20.Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 weeks post surgical bilateral oophorectomy and/or hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, hysterectomy), hormonal contraception (implantable, patch, oral), and double –barrier methods1 (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)
- •21.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml)
- •22.Any surgical or medical condition which, at the discretion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period
研究者
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