A PROSPECTIVE STUDY TO ASSESS THE INTERACTION BETWEEN PATIENT GENOTYPE AND ROSTAFUROXIN EFFECTS ON ARTERIAL BLOOD PRESSURE AND KIDNEY FUNCTION IN NEVER-TREATED HYPERTENSIVE TYPE 2 DIABETES PATIENTS (AN OPEN LABEL STUDY WITH BLINDED PATIENT GENOTYPE) - Rostafuroxin (PST2238) in Type 2 diabetes

IST. DI RICERCHE FARMACOLOG. M. NEGRI0 个研究点开始时间: 2012年3月5日最近更新: 2014年1月27日

适应症

试验速览

暂无简介。

•- Male and female patients; - Age > 18 years; - Hypertensive type 2 diabetes never-treated office systolic BP >135 mmHg in at least two consecutive visits one week apart (see Appendix 2); - High-normal, micro- or macro- albuminuria (urinary albumin excretion >10 mg/24 hours); - Normal kidney function (serum creatinine levels <1.4 mg/dl); - Capable of understanding the purpose of the study; - Written informed consent (signed and dated by the patient).
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Concomitant treatment with drugs potentially affecting arterial BP, albuminuria or kidney function; - Secondary or grade 3 or more arterial hypertension (according to 2007 ESH/ESC Hypertension guidelines); - Non-diabetic renal disease, urinary tract infection, cardiovascular events over the last six months; - Any clinically relevant conditions that might affect study participation and/or study results; - Any contraindication to be exposed to Rostafuroxin; - Pregnancy or lactating; - Women of childbearing potential without following a scientifically accepted form of contraception; - Legal incapacity.

发起方

IST. DI RICERCHE FARMACOLOG. M. NEGRI