EUCTR2012-004300-35-DE进行中（未招募）不适用
Effects of Linagliptin on Endothelial- , Renal-, and Retinal Function in Comparison to Placebo in Patients with Hypertension and Albuminuria
Profil Mainz GmbH & Co KG0 个研究点开始时间: 2012年12月5日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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.Patient has signed and dated written informed consent to participate in the trial
- •2.Arterial hypertension
- •3.Stable antihypertensive treatment within the last 3 months
- •4.Age = 45 – = 80 years
- •5.Micro- or macroalbuminuria defined as UACR in morning urine > 20 mg/g in female and > 30 mg/g in male and/or arterial hypertension for more than 5 years currently treated with two or more antihypertensive drugs to control blood pressure and a history of cardiovascular disease or stroke.
- •6.Patient consents that his/her family physician will be informed of trial participation
- •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 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
排除标准
- •1.History of type 1 diabetes
- •2.History of type 2 diabetes
- •3.Uncontrolled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg)
- •4.Acute infections
- •5.Any history of glomerulonephritis
- •6.Any kidney disease not caused by hypertension as judged by the Investigator
- •7.Glomerular filtration rate (GFR) < 30 ml/min (estimated by use of the Modification of Diet in Renal Disease (MDRD) formula)
- •8.Medical history of hypersensitivity to the study drugs or to drugs with similar chemical structures
- •9.History of severe or multiple allergies
- •10.Treatment with any other investigational drug within 3 months before trial entry
- •11.Progressive fatal disease
- •12.History of drug or alcohol abuse in the past 2 years
- •13.Condition after kidney transplantation
- •14.Serum potassium > 5.5 mmol/L
- •15.Pregnancy or breast feeding
- •16.Sexually active woman of childbearing age not practicing a highly effective method of birth control as defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomised partner.
- •17.Acute myocardial infarction, open heart surgery or cerebral event (stroke/TIA) within the previous 3 months
- •18.Any elective surgery during study participation
- •19.Uncontrolled unstable angina pectoris
- •20.Intake of Coumarin or coumarin derived compounds such as phenprocoumon (Marcumar) or warfarin (Coumadin, Warfant)
- •21.Intake of rifampicin or carbamazepine
- •22.HbA1c = 6,5%
- •23.A Body Mass Index of > 35 kg/m²
- •24.CHF NYHA stage III – IV
研究者
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