Type 2 Diabetes. MedDRA version: 14.1 Level: LLT Classification code 10015491 Term: Essential hypertension, unspecified System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.1 Level: LLT Classification code 10012612 Term: Diabetes mellitus non insulin-dep System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: rostafuroxin
Product Code: PST2238
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: rostafuroxin
CAS Number: NA
Current Sponsor code: PST2238
Other descriptive name: NA
Concentrat
Sponsors
IST. DI RICERCHE FARMACOLOG. M. NEGRI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female patients; - Age > 18 years; - Hypertensive type 2 diabetes never-treated office systolic BP >135 mmHg in at least two consecutive visits one week apart (see Appendix 2); - High-normal, micro- or macro- albuminuria (urinary albumin excretion >10 mg/24 hours); - Normal kidney function (serum creatinine levels =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Concomitant treatment with drugs potentially affecting arterial BP, albuminuria or kidney function; - Secondary or grade 3 or more arterial hypertension (according to 2007 ESH/ESC Hypertension guidelines); - Non-diabetic renal disease, urinary tract infection, cardiovascular events over the last six months; - Any clinically relevant conditions that might affect study participation and/or study results; - Any contraindication to be exposed to Rostafuroxin; - Pregnancy or lactating; - Women of childbearing potential without following a scientifically accepted form of contraception; - Legal incapacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the reduction in office systolic BP and albuminuria (mean of three consecutive measurements in 24-hour urine collections) after 5 weeks Rostafuroxin therapy between two subsets of hypertensive type 2 diabetic patients with or without a pre-defined genetic profile (Profile 1) expected to be associated with adducin/ouabain dependent arterial hypertension and glomerular dysfunction.;Secondary Objective: • To compare between-group treatment-induced changes in the following parameters: - In office diastolic, mean and pulse BP; - Mean 24-hour systolic, diastolic, mean and pulse BP; - Day-time and night-time systolic, mean, diastolic and pulse BP; - Pulse wave velocity and other markers of vascular stiffness; - Glomerular filtration rate (as measured by the iohexol plasma clearance); - Albumin and IgG fractional clearance. • To explore the relationships between treatment-induced changes in office and 24-hour BP and concomitant changes in albuminuria in the study group as a whole and within each genotype group considered separately. • To assess treatment safety and tolerability (by evaluation of vital signs and routine laboratory parameters) in the study group as a whole and within each genotype group considered separately. • To explore the possibility that the response to Rostafuroxin is confined or present in the subset of patients carrying the profile 1;Primary end point(s): - Office systolic BP - Albuminuria (mean of three consecutive measurements in 24-hour urine collections) | — |
Countries
Italy
Outcome results
None listed