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

• Conditions: Orthostatic hypotension in hypertensive patients with type 2 diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10031127Term: Orthostatic hypotension

• Registration Number: EUCTR2007-004438-18-IE
• Lead Sponsor: Menarini International Operations, Luxembourg S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 404

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified