EUCTR2006-004586-34-GR进行中（未招募）不适用
A double-blind, randomized, multicenter, parallel group study to evaluate the efficacy, tolerability, and safety of treatment with the combination of valsartan/amlodipine 160/5 mg compared to amlodipine 10 mg in patients with essential hypertension not adequately controlled with amlodipine 5 mg alone
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,018
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
- 性别
- All
入选标准
- •1.Male or female outpatients = 55 years of age
- •2.Patients with essential hypertension measured using a validated automated oscillometric device at Visit 1
- •Non-treated patients must have a MSSBP =?140 mmHg and = 160 mmHg
- •Patients pre-treated on monotherapy prior to Visit 1 must have MSSBP = 160 mmHg
- •3.To be eligible for randomization at Visit 2 (Day 1) all patients must have a MSSBP =?130 mmHg and = 160 mmHg
- •4.No peripheral edema at Visit 2 (randomization)
- •5.Written informed consent to participate in this study prior to any study procedures
- •Are the trial subjects under 18? no
- •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.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant
- •2.Known or suspected contraindications, including history of allergy or hypersensitivity to angiotensin receptor blockers, calcium channel blockers, or to drugs with similar chemical structures
- •3.Patients taking more than 1 antihypertensive medication at Visit 1
- •4.Administration of any agent indicated for the treatment of hypertension after Visit 1 with the exception of pre-treated patients that require tapering down of anti-hypertensive treatments. For patients with previous antihypertensive medication that require a gradual downward titration, the tapering down should be done according to manufacturers instructions and last dose should be taken by week -2 prior to randomization
- •5.MSSBP > 180mmHg or MSDBP ? 110 mmHg at any time between Visit 1 and Visit 2
- •6.Evidence of a secondary form of hypertension, including but not limited to any of the following: coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing’s disease, polycystic kidney disease, or pheochromocytoma
- •7.History of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, myocardial infarction, percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) 12 months prior to Visit 1
- •8.History of heart failure Grade II - IV according to the NYHA classification
- •9.Second or third degree heart block with or without a pacemaker
- •10.Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia
- •11.Concomitant unstable angina pectoris
- •12.Clinically significant valvular heart disease
- •13.Patients with Type 1 diabetes mellitus
- •14.Patients with Type 2 diabetes mellitus who are not well controlled based on the investigator’s judgment. It is recommended that Type 2 diabetic patients are adequately controlled and, if treated with medication, be on a stable dose of oral anti-diabetic medication for at least 4 weeks prior to Visit 1.
- •15.Evidence of hepatic disease as determined by one of the following: AST or ALT values > 2 x UNL at Visit 1, a history of hepatic encephalopathy, history of esophageal varices, or history of portocaval shunt
- •16.Evidence of renal impairment as determined by one of the following: serum creatinine >1.5 x UNL at Visit 1, history of dialysis, or history of nephrotic syndrome
- •17.Serum potassium values > 5.5 mmol/L at Visit 1
- •18.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug
- •19.Any surgical or medical condition which, at the discretion of the investigator or Novartis medical monitor, 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
- •20.Volume depletion based on the investigator’s clinical judgment using vital signs, skin turgor, moistness of mucous membranes, and laboratory values
- •21.Any severe, life-threatening disease within the past five years
- •22.History of drug or alcohol abuse within the last 2 years
- •23.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- •24.Inability to communicate and comply with all study requirements including the unwillingness or inability to provide informed consent
- •25.Persons directly involved in the exe
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