NL-OMON34045已完成3 期
Renal hemodynamic effects of aliskiren (rasilez) in comparison to ramipril (tritrace) in patients with overweight/obesity and hypertension - The renal HEALTH-STudY
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Male caucasian patients
- •- Age >=18 and <=70 years
- •- Overweight or obese (BMI >=27 and <=35 kg/m2)
- •- Essential hypertension according to WHO-criteria (systolic and diastolic blood pressure >=140 or
- •>=90 mmHg, respectively)
- •- Normal renal function (creatinine clearance >90 ml/min/1.73m2)
- •- Normo- or microalbuminuria (albuminuria <=300mg/day)
- •- Written informed consent
排除标准
- •- Inability to meet inclusion criteria
- •- Previously treated (within 3 months prior to start of study) with aliskiren or ramipril.
- •- Cardiovascular disease (myocardial infarction, angina pectoris, percutanous transluminal
- •coronary angioplasty, coronary artery bypass grafting, stroke, heart failure (NYHA I-IV), Diabetes
- •- Active malignancy
- •- Any medication, surgical or medical condition which might significantly alter the absorption,
- •distribution, metabolism, or excretion of medications including, but not limited to any of the
- •- History of active inflammatory bowel disease within the last six months;
- •- Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel
- •- Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months;
- •- Pancreatic injury or pancreatitis within the last six months;
- •- Evidence of hepatic disease as determined by any one of the following: ALT or AST values
- •exceeding 3x ULN at inclusion visit, a history of hepatic encephalopathy, a history of
- •esophageal varices, or a history of portocaval shunt;
- •- Evidence of urinary obstruction of difficulty in voiding at inclusion
- •- History of severe hypersensitivity or contraindications to ramipril or aliskiren
- •- Hypersensitivity to 125I-iothalamate or 131I-hippuran
- •- History of angioedema
- •- History of autonomic dysfunction (e.g. history of fainting or clinically significant orthostatic
- •hypotension)
- •- Participation in any clinical investigation within 3 months prior to start of the study
- •- Donation or loss of 400 ml or more of blood within 3 months prior to initial dosing
- •- History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse
- •as indicated by the laboratory assays conducted during the screening.
- •- History of noncompliance to medical regimens or unwillingness to comply with the study
- •- 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.
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