A PROSPECTIVE, RANDOMIZED, OPEN LABEL BLINDED END POINT (PROBE), CROSS-OVER STUDY TO COMPARE THE EFFECTS OF TELMISARTAN AND LOSARTAN ON METABOLIC PROFILE OF RENAL TRANSPLANT PATIENTS - Telmisartan versus Losartan in kidney transplantation

IST. DI RICERCHE FARMACOLOG. M. NEGRI0 个研究点开始时间: 2009年3月31日最近更新: 2013年9月23日

试验速览

暂无简介。

•- Informed consent; - Age > 18 years; - Single or dual marginal renal transplant > 6 months duration; - Blood pressure >130/85 mmHg or need for anti-hypertensive therapy; - Stable renal function (changes in serum creatinine < 30%) and no acute rejection episodes in the last six months; - Stable (for at least six months) dual or triple immunosuppressive therapy including corticosteroids or calcineurin inhibitors; - Legal capacity.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 17
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 3

•- Vascular disease of the kidney; - Heart failure: NYHA classification class III-IV on ACE or AII inhibitor therapy; - Cerebral haemorrhage, stroke or TIA within three months prior to study enrolment; - Myocardial infarction within three months prior to study enrolment; - Unstable angina pectoris; - Severe hepatic disease; - Pregnancy or women of child-bearing potential without following a scientifically accepted form of contraception; - Overt diabetes or concomitant treatment with oral antidiabetic agents and/or insulin; - Specific contraindications or history of hypersensitivity to the study drugs, glitazones, ACE inhibitors or AII receptor antagonists; - Participation to other clinical trials over the last three months; - Legal incapacity; - Previous diagnosis of: intellectual disability/mental retardation, dementia, schizophrenia.

发起方

IST. DI RICERCHE FARMACOLOG. M. NEGRI