EUCTR2004-003905-26-DE进行中（未招募）不适用
A 12-week, double-blind, parallel group study to evaluate the efficacy and safety of the combination of aliskiren with HCTZ compared to irbesartan or amlodipine with HCTZ or HCTZ alone in hypertensive patients with BMI = 30 kg/m2 not adequately responsive to HCTZ 25 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
- 496
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 18 years of age and older.
- •2.Patients with essential hypertension (MSDBP ? 95 mmHg and < 110 mmHg)
- •3.Patients with a body mass index = 30 kg/m2
- •4.Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
- •To be eligible for the single-blind HCTZ period at Visit 2 and randomization at Visit 4, all patients must fulfill the following criteria:
- •5.Patients must have a MSDBP ? 95 mmHg and < 110 mmHg at Visit 2.
- •6.Patients must have a MSDBP = 90 mmHg and < 110 mmHg at Visit 4.
- •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.Patients who previously entered an aliskiren study and who qualified to be randomized or enrolled into the active drug treatment period.
- •2.Severe hypertension (MSDBP = 110 mmHg and/or MSSBP = 180 mmHg)
- •3.History or evidence of a secondary form of hypertension
- •4.Known Keith-Wagener grade III or IV hypertensive retinopathy.
- •5.History of hypertensive encephalopathy or cerebrovascular accident
- •6.Transient ischemic cerebral attack during the 12 months prior to Visit 1.
- •7.Previous and current diagnosis of heart failure (NYHA Class II-IV).
- •8.History of myocardial infarction.
- •9.Coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.
- •10.Current angina pectoris requiring pharmacological therapy (other than patients on a stable dose of oral or topical nitrates)
- •11.Second or third degree heart block without a pacemaker.
- •12.Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
- •13.Clinically significant valvular heart disease.
- •14.Patients with current diagnosis of diabetes (Type 1 or 2)
- •15.Serum sodium less than the lower limit of normal, serum potassium < 3.5 mEq/L (corresponding to 3.5 mmol/L) or = 5.5 mEq/L (corresponding to 5.5 mmol/L), or dehydration at Visit 1.
- •16.Any surgical or medical condition which 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 (corresponding to 150 µmol/L) for women and serum creatinine >2.0 mg/dl (corresponding to 177 µmol/L) for men at Visit 1, a history of dialysis, or a history of nephrotic syndrome.
- •Current treatment with cholestyramine and colestipol resins.
- •17.History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
- •18.History or evidence of drug or alcohol abuse within the last 12 months.
- •19.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).
- •20.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.
- •21.History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
- •22.Any condition that in the opinion of the investigator or the Novartis medical mon
研究者
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