Orthostatic hypotension in hypertensive patients with type 2 diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10031127 Term: Orthostatic hypotension
Conditions
Interventions
Trade Name: Nebilet
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Nebivolol
CAS Number: 99200-09-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2,5-
Ph
Sponsors
Menarini International Operation Luxembourg S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the impact of add-on treatment with Nebivolol and Carvedilol on orthostatic hypotension (OH) in patients with diabetes and hypertension. ;Secondary Objective: The secondary objective of this study is to evaluate the impact of add-on treatment with Nebivolol and Carvedilol on glucose and lipid profile, on microalbuminuria, on OH symptoms, on dosage of antidiabetic treatment and the safety and tolerability. ;Primary end point(s): The primary efficacy endpoint of this study is to evaluate the effects of Nebivolol and Carvedilol on OH by comparing the mean differences between standing BP and supine BP. For all post-baseline visits it will be tested whether the mean difference dneb,i in the Nebivolol treatment group is significantly larger than the mean difference dcar,i in the Carvedilol treatment group. The confirmatory analysis of the primary efficacy parameter will be for Visit 3 and 5, for the other visits the analysis will be exploratory in nature. The secondary efficacy endpoints of this study are to assess change from baseline of •Lipid profile (serum cholesterol level, serum triglycerides, serum High density lipoprotein [HDL], serum Very low density lipoprotein [VLDL], Low density lipoprotein [LDL]) •Glucose profile (glycosylated haemoglobin [HbA1c], fasting glucose and insulin) •Microalbuminuria (urinary albumin/creatinine excretion rate [microgr/mg]) on night urine •Dosage of oral antidiabetics and/or insulin •Results on Orthostatic Grading Scale (OGS) •optional: Marker of vascular oxidative stress (plasma soluble P-selectin [sP-sel], Interleukin [IL]-1, IL-6, intercellular adhesion molecule [ICAM], Vascular cell adhesion molecule [VCAM]) at selected sites and to assess the incidence of symptoms of acute OH after standing BP measurements | — |
Countries
Austria, Belgium, Ireland, Latvia
Outcome results
None listed