Antihypertensive effect of different doses of Rostafuroxin in comparison with Losartan, assessed by office and ambulatory blood pressure monitoring in a hypertensive population selected according to a specific genetic profile. - PEARL-HT

CVIE THERAPEUTICS COMPANY LIMITED0 个研究点目标入组 280 人开始时间: 2010年12月27日最近更新: 2019年11月25日

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•The main criteria to be included in the study is to be a patient with arterial hypertension, bearers of a specific genetic profile (Genetic Profile 1). Patients have to be aged between 25 and 60 years, have already undertaken lifestyle recommendations and still having an abnormal systolic and diastolic blood pressure levels. They must not have been previously treated with any specific antihypertensive drug and they must not assume drugs like diuretics, ?-blocker agents, Ca-antagonist, ACE inhibitors and AT1-receptor blockers, for other reasons. They must not be on statines treatment or to be Diabetic (fasting plasma glucose > 125 mg/dl). Their value of the sitting systolic blood pressure (SBP) must range between 140 and 169 mmHg and the sitting diastolic blood pressure (DBP) must range between 85 and 100 mmHg, after an adequate period of lifestyle changes. They do not have to present known causes of secondary hypertension, cardiac disease requiring prohibited pharmacological treatment or history of renal artery disease or a myocardial infarction occurred within the last 6 months.
•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 280
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Known causes of secondary hypertension; •Severe or malignant hypertension; •History of renal artery disease; •Significant renal (estimated creatinine clearance = 50 mL/min) or hepatic disease (SGOT and/or SGPT greater than 2 times the upper limit of the normal range); •Cardiac disease requiring prohibited pharmacological treatment or history of myocardial infarction within the last 6 months; •Atrial Fibrillation.

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CVIE THERAPEUTICS COMPANY LIMITED