EUCTR2007-004438-18-BEActive, not recruitingPhase 1
Comparative effects of Nebivolol and Carvedilol on orthostatic hypotension in hypertensive patients with type 2 diabetes mellitus (DIANECA) - DIANECA
A. Menarini Farmaceutica Internazionale s.r.l.0 sites404 target enrollmentStarted: January 29, 2008Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 404
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Investigators
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