EUCTR2011-005297-36-ES进行中（未招募）不适用
An 8-week randomized, open label, multi-center study to study to evaluate the efficacy and safety of oral aliskiren 300 mg once daily under light meal versus fasted condition in patients with hypertension
ovartis Farmaceutica SA0 个研究点目标入组 568 人开始时间: 2011年12月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 568
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
- •Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- •1.Written informed consent must be obtained before any assessment is performed
- •2.Male or female outpatients age ? 18 years old
- •3.Patients with essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy).
- •4.Patients must have an office BP ? 140/90 mmHg and < 180/110 mmHg at the randomization visit and the preceding visit
- •5.Patients must have an absolute difference of ? 10 mmHg in both their msSBP and in their msDBP between the randomization visit and the preceding visit
- •6.Ability to communicate and comply with all study requirements
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 168
排除标准
- •Patients with any of the following physiological states or concomitant medical conditions at Visit 1, Visit 2, Optional Visit 201 or Visit 3 will be excluded from participation in the study.
- •1.Malignant hypertension or severe hypertension (grade 3 of WHO classification; msSBP ?180 mmHg or msDBP ?110 mmHg)
- •2.History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
- •3.History or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, Cushing?s disease, drug-induced hypertension, pheochromocytoma and polycystic kidney disease (PKD)
- •4.History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneaous arterial intervention of any kind (coronary, carotid or peripheral intervention), stroke, TIA (transient ischemic attack), carotid artery stenosis, aortic aneurysm or peripheral arterial disease with in 6 months of Visit 1
- •5.Type 1 or Type 2 diabetes mellitus with fasting glycosylated hemoglobin (HbA1c) > 8%
- •6.Clinically significant valvular heart disease
- •7.Previous or current diagnosis of congestive heart failure NYHA Class II to IV
- •8.Second or third degree heart block without a pacemaker, potentially life threatening arrhythmia, symptomatic arrhythmia, or family history of torsade de pointe
- •9.Evidence of hepatic disease as determined by one of the following: ALT or AST values ? 3 x ULN at Visit 1, or a history of liver cirrhosis, hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
- •10.Evidence of renal impairment as determined by one of the following: serum creatinine >1.5 x ULN or eGFR < 30 ml/min/1.73m2 at Visit 1, a history of dialysis, or a history of nephrotic syndrome
- •11.Other significant laboratory findings such as anemia defined as Hb < 10 g/dL, serum sodium value < 132 mmol/L or serum potassium values <3.5 mmol/L or >5.3 mmol/L at Visit 1
- •12.Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of aliskiren, including but not limited to, any of the following: history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling, or gastric banding, currently active, or active inflammatory bowel syndrome within 12 months prior to Visit 1, regarded as clinically meaningful by the investigator
- •13.Patients with active gastritis, active peptic ulcer, gastro-esophageal reflux requiring medical therapy, gastrointestinal/rectal bleeding, or urinary tract obstruction regarded as clinically meaningful by the investigator
- •14.Patients unwilling or unable to discontinue safely the use of current antihypertensive medications for a period up to 12 weeks, as required by the protocol. Administration of any agent indicated for the treatment of hypertension after Visit 1, with the permitted exception of those anti-hypertensive medications requiring tapering down commencing at Visit 1 and completing by Visit 2
- •15.History of drug or alcohol abuse within the last 1 year
- •16.History of angioedema, drug-related or otherwise
- •17.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever i
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