Metabolic syndrome (at least 2criteria) or diabetes mellistus type II. and primary hypertension
Conditions
Interventions
Trade Name: Amprilan H 5 mg/25 mg
Pharmaceutical Form: Tablet
Trade Name: Amprilan 5
Pharmaceutical Form: Tablet
Trade Name: Amprilan 10
Pharmaceutical Form: Tablet
Trade Name: Atoris 10
Pharmaceut
Sponsors
DSC Services, s.r.o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diabetes mellitus type II. and primary hypertension (systolic pressure > 130 mmHg or diastolic pressure > 85 mmHg ) Two criteria of metabolic syndrome Age > 40 Informed consent 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: Myocardial infarction, stroke, PTCA, CABG in the last 3 months Secondary hypertension Clinically apparent heart failure Diabetes mellitus type I. Comorbidity with bad prognosis (death expectation > 30%) Gravidity and fertile women without sufficient contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is to lower the absolute risk evaluated by SCORE as well as to increase the number of patients with SCORE level below 5%.;Secondary Objective: Percentage of patients with blood pressure < 140/90 mmHg. Percentage of patients with cholesterol < 5,0 mmol/l. Percentage of patients not complying with the criteria for metabolic syndrome. Renal function evaluated as glomerular filtration and microalbuminuria. Variation in glycated hemoglobin. ;Primary end point(s): SCORE | — |
Countries
Czech Republic
Outcome results
None listed