iaspan for the treatment of endothelial dysfunction in patients without hyperlipoproteinemia - ENDOTHE

Charité - Universitätsmedizin Berlin0 个研究点目标入组 30 人开始时间: 2007年6月4日最近更新: 2022年3月14日

适应症

试验速览

暂无简介。

•Patient information and written informed consent
•Patients with endothelial dysfunction shown via an analysing with the FMD-
•Age between 18 - 70 years
•no similar therapy in the anamnesis
•estimated life expectancy of at least 5 years
•-sufficent renal function (creatinine =1,0 mg/dl and urea = 46 mg/dl for ?; creatinine =1,2mg/dl and urea = 46 mg/dl for ?)
•sufficient liver function (alanine aminotransferase (ALT) : =45 U/l; AST: =50 U/l; both for ? and ?)
•No pregnancy
•Highly effective contraception for the time of the therapy and 6 months afterwards. Pearl index<1, for example: contraceptive pill, loop, hormone implant, transdermal applicator, a combination of two barrier methods (e.g. condom and diaphragm), sterilization, sexual abstinence.
•Accessibility of the patient for treatment and follow-up
•Compliance of the the patient
•Not included the last 3 months in an other clinical trial
•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

•Coronary vessels disease and othervesels disease like peripheral arterial disease.
•Hyperlipoproteinemia
•Diabetes mellitrus typ 1 and 2
•Arterial hypertension systolic > 160 mmHg and diastolic > 90 mmHg
•Alcohol abuse or history of alcohol abuse
•Active tumor disease
•Active liver disease like hepatitis B, C
•After a chemotherapy in the last 6 months
•Less as 6 months after cerebral ischemia
•Known neurological and psychiatric illness
•Known kidney disease (kreatinin > 1,0 mg/dl for ?, and > 1,2 mg/dl for ?)
•Renale Anemia
•liver insufficience (total bilirubin >1,0 mg/dl , ALT > 50 U/l and AST > 45 U/l for ? and ?)
•Known pregnancy
•Women, who would not drive through appropriate preventing (Pearl index > 1)
•All exclusion criteria against Niaspan®: Hypersensitivity to nicotinic acid or against a component, known acute gastric ulcer, known hemorrhage
•Cotreatment with medicine like hormons, EPO, statine, immunosuppressive drugs
•Known HIV-infection
•Patients who do not give the allowness to save their data
•Patients which are included in an other clinical trial

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