Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the superiority of atorvastatin/perindopril fixed dose combination (FDC) S05167 as compared to atorvastatin reference drug alone or perindopril drug alone on systolic blood pressure decrease and LDL cholesterol decrease respectively in patients presenting with hypertension and dyslipidemia after 8 weeks of treatment.

Official Title
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Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia, 8 Weeks, Phase 3, Randomized, Double-blind, Active-control, Multinational, Multi-center, Parallel Study

Conditions
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Dyslipidemias, Hypertension

Intervention / Treatment
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* Drug: Atorvastatin/Perindopril
* Drug: Atorvastatin
* Drug: Perindopril


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women from 18 to 79 years old who can comply with the study requirements and timetable, Patients diagnosed with Essential hypertension (as documented in patient's medical file). The diagnosis of hypertension should be based on at least two BP measurements on at least two visits. Uncontrolled hypertensive patients currently under monotherapy treatment within at least 4 weeks (except patients treated by perindopril) for combined systolic and diastolic hypertension (140 mmHg ≤ SBP < 160 mmHg and 90 mmHg ≤ DBP < 100 mmHg). or Hypertensive patients naïve of treatment with 150 mmHg ≤ SBP <160 mmHg and 90 mmHg ≤ DBP < 100 mmHg. Dysplipidemic patients: naïve of treatment or uncontrolled with statin at lowest dose within at least 4 weeks with 110 mg/ Decilitre (dL) (or 2.84 millimole [mmol] /L) ≤ LDL-c < 190 mg/dL (or 4.91 mmol/L) according to a previous laboratory result within 12 months. Exclusion Criteria: Unlikely to cooperate in the study, Pregnant and lactating women, 4. Participation in another study at the same time or having participated in another study within 3 months before selection participation in noninterventional registries or epidemiological studies is allowed, 6.Patients treated with >1 anti-hypertensive drug or >1 Lipid lowering drug, 7.Patients previously treated with atorvastatin and/or perindopril, 8.Known resistance to ACE inhibitors, 9.Patients treated with beta-blockers or alpha-blockers, 10. Patients with liver disease or renal impairment, 11.Certain known cardiovascular diseases or cardiac rhythm disorders, 12.Known or suspected symptomatic orthostatic hypotension, 13.Familial hypercholesterolemia, 14.Secondary hypertension or dyslipidemia, 15.Patients who are hypersensitive to atorvastatin, perindopril or to any of the excipients of study drugs, 16.Hypersensitivity to any other ACE inhibitor, 17.History of angioedema associated with previous ACE inhibitor therapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S05167<br> | Drug: Atorvastatin/Perindopril<br>* 1 over-encapsulated S05167 capsule, fixed dose combination of Atorvastatin/Perindopril Arginine 40/10 mg, will be administered once daily each day before breakfast during 8 weeks.<br>|
| Active Comparator: Lipitor®<br> | Drug: Atorvastatin<br>* 1 over-encapsulated atorvastatin 40 mg tablet will be administered once daily each day before breakfast during 8 weeks.<br>|
| Active Comparator: Coversyl®<br> | Drug: Perindopril<br>* 1 over-encapsulated perindopril 10 mg tablet will be administered once daily each day before breakfast during 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure (SBP) | Mean change from baseline in sitting systolic blood pressure (SBP) in the S05167 group as compared with the Lipitor group (in terms of superiority) | Over 8 weeks | 
| Low-Density Lipoprotein Cholesterol (LDLc) | Percent of change from baseline in Low-Density Lipoprotein Cholesterol (LDLc) in the S05167 group as compared with the Coversyl group (in terms of superiority) | Over 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure (SBP) | Mean change from baseline in sitting systolic blood pressure (SBP) in the S05167 group as compared with Coversyl group | Over 8 weeks | 
| Density Lipoprotein Cholesterol (LDLc) | Percent of change from baseline in Low-Density Lipoprotein Cholesterol (LDLc) level in the S05167 group as compared with the Lipitor group | Over 8 weeks | 
| Diastolic blood pressure (DBP) | Mean change from baseline in diastolic blood pressure (DBP) in each group | Over 8 weeks | 
| Pulse Pressure | Mean change from baseline Pulse Pressure in each group | Over 8 weeks | 
| Lipid parameters | Percent of Change from baseline | Over 8 weeks | 
| Blood pressure response | Percent of responders (in terms of blood pressure response defined by patients with BP< 140/90 mm Hg or SBP decrease > = 20 mm Hg or DBP decrease > =10 mm Hg) | Over 8 weeks | 
| Blood pressure control | Percent of blood pressure control: BP< 140/80 mm Hg AND % of blood pressure control: BP < 130/80 mm Hg | Over 8 weeks | 
| Lipids control | Percent of responders (in terms of lipids control: an absolute reduction to an LDLc level< 2.6 mmol/L [100 mg/dL] or a reduction at least 50% | Over 8 weeks | 
| Adverse events and Serious adverse events (SAE) | Emergent Adverse events and Serious adverse events (SAE) | Over 8 weeks | 
| Vital signs | Blood pressure (BP) | Over 8 weeks | 
| Vital signs | Pulse rate (PR) | Over 8 weeks | 
| Vital signs | Respiratory rate (RR) | Over 8 weeks | 
| Electrocardiogram | Significant abnormalities observed from ECG | Over 8 weeks | 
| Clinical lab tests | Relevant deviations of laboratory test results | Over 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyslipidemia, Hypertension, Cardiovascular, Atorvastatin, Perindopril, HMG-CoA reductase inhibitor, ACE inhibitor, Fixed combination