EUCTR2010-021987-13-NL进行中（未招募）不适用
Renal Hemodynamic Effects of ALiskiren (rasilez) in comparison to ramipril (Tritrace) in patients with overweigHt/obeSiTy and UntreateD hYpertension: The renal HEALTH-STUDY - The renal HEALTH-STUDY
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
- 16
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
- Male
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/1.73mm2)
- •- Normo- or microalbuminuria (albuminuria =300mg/day)
- •- Written informed consent
- •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
- •- 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 Mellitus
- •- 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 following:
- •- History of active inflammatory bowel disease within the last six months;
- •- Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or
- •bowel resection;
- •- Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six
- •- 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 8 weeks prior to initial dosing or
- •longer if required by local regulation.
- •- 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
- •- History of noncompliance to medical regimens or unwillingness to comply with the
- •study protocol.
- •- 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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