Arterial Hypertension, Blood Pressure, Dyslipidemias, Lipid Metabolism Disorders
Conditions
Keywords
Arterial hypertension, Dyslipidemia, Blood pressure control, Fixed combination
Brief summary
The aim of this study is to compare the effect of fixed and free combination of atorvastatin/perindopril/amlodipine on blood pressure and lipid levels.
Interventions
DRUGAtorvastatin, Amlodipine, Perindopril
To compare free and fixed combination of atorvastatin, perindopril, amlodipine
Sponsors
University Hospital Olomouc
University Hospital Pilsen
General Teaching Hospital, Prague
St. Anne
Brno University Hospital
Na Homolce Hospital
Charles University, Czech Republic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with uncontrolled arterial hypertension (the average 24h blood pressure in the range 130/80 - 180/110 mmHg and / or daytime average blood pressure in the range 135/85-180/110 mmHg) and one of the following: 1. a very high cardiovascular risk and LDL-cholesterol\> 1.8 mmol / l 2. a high cardiovascular risk and LDL-cholesterol\> 2.5 mmol / l 3. Patient with a high or very high cardiovascular risk treated by lipidlowering therapy with statin
Exclusion criteria
1. hypersensitivity to perindopril or to other ACE inhibitors, amlodipine, atorvastatin, dihydropyridines or to or statins 2. angioneurotic edema in medical history (hereditary / idiopathic or associated with prior treatment with ACE inhibitors) 3. severe hypotension, shock, including cardiogenic shock 4. hemodynamically unstable heart failure 5. Active liver disease or unexplained persistent elevations of serum transaminases more than three times normal 6. Women of childbearing age without reliable contraception 7. pregnancy 8. breastfeeding 9. Patients with contraindications listed in the currently valid SP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure control | 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine | To compare the effect of fixed and free combination of atorvastatin/perindopril/amlodipine on 24h and in clinic blood pressure over the 16 weeks follow up. |
| Lipids control | 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine | To compare the effect of fixed and free combination of atorvastatin/perindopril/amlodipine on LDL cholesterol levels over the 16 weeks follow up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine | 1\. To compare the effect of fixed and free combination of atorvastatin/perindopril/amlodipine on adherence evaluated by the Morisky medication adherence scale 8 and tablet counting over the 16 weeks follow up. |
| Blood pressure variability | 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine | To compare the effect of fixed and free combination of atorvastatin/perindopril/amlodipine on 24h blood pressure variability over the 16 weeks follow up. |
| Arterial properties | 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine | o compare the effect of fixed and free combination of atorvastatin/perindopril/amlodipine on arterial properties and central hemodynamic parameters measured during the 24 monitoring by the Mobilograph device over the 16 weeks follow up. |
Countries
Czechia
Outcome results
None listed