Fixed Combination for Lipid and Blood Pressure Control

Study Overview
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Brief Summary
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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.

Official Title
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Fixed Combination for Lipid and Blood Pressure Control. Randomized Cross-over Study

Conditions
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Arterial Hypertension, Dyslipidemias, Blood Pressure, Lipid Metabolism Disorders

Intervention / Treatment
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* Drug: Atorvastatin, Amlodipine, Perindopril


Participation Criteria
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Eligibility Criteria
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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: a very high cardiovascular risk and LDL-cholesterol> 1.8 mmol / l a high cardiovascular risk and LDL-cholesterol> 2.5 mmol / l Patient with a high or very high cardiovascular risk treated by lipidlowering therapy with statin Exclusion Criteria: hypersensitivity to perindopril or to other ACE inhibitors, amlodipine, atorvastatin, dihydropyridines or to or statins angioneurotic edema in medical history (hereditary / idiopathic or associated with prior treatment with ACE inhibitors) severe hypotension, shock, including cardiogenic shock hemodynamically unstable heart failure Active liver disease or unexplained persistent elevations of serum transaminases more than three times normal Women of childbearing age without reliable contraception pregnancy breastfeeding Patients with contraindications listed in the currently valid SP

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Free combination<br>Free combination of atorvastatin, perindopril and amlodipine will be given for 8 weeks. After 8 weeks free combination will be changed to fixed combination. The dose of each drug will be selected according to clinical judgement of each investigator, but can not be changed during the coarse of the study. | Drug: Atorvastatin, Amlodipine, Perindopril<br>* To compare free and fixed combination of atorvastatin, perindopril, amlodipine<br>|
| Active Comparator: Fixed combination<br>Fixed combination of atorvastatin, perindopril and amlodipine will be given for 8 weeks. After 8 weeks fixed combination will be changed to free combination. The dose of each drug will be selected according to clinical judgement of each investigator, but can not be changed during the coarse of the study. | Drug: Atorvastatin, Amlodipine, Perindopril<br>* To compare free and fixed combination of atorvastatin, perindopril, amlodipine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure control | 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. | 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine | 
| Lipids control | To compare the effect of fixed and free combination of atorvastatin/perindopril/amlodipine on LDL cholesterol levels over the 16 weeks follow up. | 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | 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. | 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine | 
| Blood pressure variability | To compare the effect of fixed and free combination of atorvastatin/perindopril/amlodipine on 24h blood pressure variability over the 16 weeks follow up. | 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine | 
| Arterial properties | 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. | 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyslipidemia, Arterial hypertension, Blood pressure control, Fixed combination