Comparative effects of Nebivolol and Carvedilol on orthostatic hypotension in hypertensive patients with type 2 diabetes mellitus (DIANECA) - DIANECA

Menarini International Operations, Luxembourg S.A0 个研究点目标入组 404 人开始时间: 2008年2月5日最近更新: 2012年3月19日

研究概览

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•Ambulant male and female patients
•>/ = 60 and = 85 years of age at the randomisation visit
•Mild and moderate hypertension defined as sitting Systolic Blood Pressure (siSBP) of >/ = 130 mmHg up to =179 mmHg and/or a sitting Diastolic Blood Pressure (siDBP) of >/ = 80 mmHg up to =109 mmHg
•Under stable treatment with any antihypertensive treatment excluding a- and ß-blockers at least one month prior to entry into the study
•type 2 diabetes mellitus diagnosed already 3 years prior to entry into the study, metabolically stable during the previous 3 months prior to entry into the study
•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

•Cardiovascular disease if clinically significant at the discretion of the Investigator as unstable angina, sick sinus syndrome, congestive heart failure, valvular disease
•Myocardial infarction or stroke within the previous 3 months
•SBP or DBP values respectively equal or greater than 180 and 110 mmHg
•Clinically relevant bradycardia < 60 beats/minute
•Chronic obstructive pulmonary disease (COPD) or bronchial asthma
•Severe peripheral vascular disease
•Urinary protein >1000 mg/day and serum creatinine >2.5 mg/dl
•Pregnant or nursing women
•Disabling or terminal illness
•History of sensitivity or significant adverse reactions to ß-blocker therapy
•Use of non ocular ß-blockers within the previous month
•Use of concomitant prohibited medication.

发起方