EUCTR2004-002410-11-DE进行中（未招募）不适用
A six-week, randomized, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of the combination of aliskiren 150 mg and amlodipine 5 mg compared to amlodipine 5 mg and 10 mg in hypertensive patients not adequately responsive to amlodipine 5 mg
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
- 566
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
- •Outpatients 18 years of age and older.
- •Male or female patients are eligible. Female patients must be either post-menopausal for one year, surgically sterile, or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide or an intrauterine device.
- •Patients with essential hypertension.
- •Non-treated patients must have a MSDBP = 95 mmHg and <110 mmHg.
- •Treated patients must have MSDBP < 110 mmHg.
- •To be eligible for single-blind treatment at Visit 2 (Day -28) all patients must have a MSDBP = 95 mmHg and < 110 mmHg and to be eligible for randomization at Visit 4 (Day 1), all patients must have a MSDBP = 90 mmHg and < 110 mmHg.
- •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
- •Patients who previously entered an aliskiren study and who qualified to be randomized or enrolled into the active drug treatment period.
- •Severe hypertension (MSDBP = 110 mmHg and/or MSSBP = 180 mmHg).
- •History or evidence of a secondary form of hypertension.
- •Known Keith-Wagener grade III or IV hypertensive retinopathy.
- •History of hypertensive encephalopathy or cerebrovascular accident.
- •Transient ischemic cerebral attack during the 12 months prior to Visit 1.
- •Current diagnosis of heart failure (NYHA Class II-IV).
- •History of myocardial infarction.
- •History of coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.
- •Current angina pectoris requiring pharmacological therapy (other than patients on a stable dose of oral or topical nitrates).
- •Second or third degree heart block without a pacemaker.
- •Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
- •Clinically significant valvular heart disease or severe aortic stenosis.
- •Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) > 9% at Visit 1.
- •Serum sodium less than the lower limit of normal, serum potassium < 3.5 mEq/L or = 5.5 mEq/L, or dehydration at Visit 1.
- •Any surgical or medical condition or treatment that might significantly alter the absorption, distribution, metabolism, or excretion of study drugs including, but not limited to, any of the following:
- •History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection.
- •Currently active or previously active inflammatory bowel disease during the 12 months prior to Visit 1.
- •Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months prior to Visit 1.
- •Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase.
- •Evidence of hepatic disease as determined by any one of the following: SGOT or SGPT values exceeding 3 x ULN at Visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt.
- •Evidence of renal impairment as determined by any one of the following: serum creatinine > 1.7 mg/dl for women and serum creatinine > 2.0 mg/dl for men at Visit 1, a history of dialysis, or a history of nephrotic syndrome.
- •Current treatment with cholestyramine and colestipol resins.
- •History of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the past five years.
- •History or evidence of drug or alcohol abuse within the last 12 months.
- •Pregnant or nursing women.
- •Known or suspected contraindications to the study medications, including history of allergy to amlodipine or dihydropyridine like calcium channel blockers.
- •Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
- •Participation in any investigational drug trial within one month of Visit 1.
研究者
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