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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
146
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.
1 over-encapsulated atorvastatin 40 mg tablet will be administered once daily each day before breakfast during 8 weeks.
1 over-encapsulated perindopril 10 mg tablet will be administered once daily each day before breakfast during 8 weeks.
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)
Time frame: 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)
Time frame: Over 8 weeks
Systolic blood pressure (SBP)
Mean change from baseline in sitting systolic blood pressure (SBP) in the S05167 group as compared with Coversyl group
Time frame: 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
Time frame: Over 8 weeks
Diastolic blood pressure (DBP)
Mean change from baseline in diastolic blood pressure (DBP) in each group
Time frame: Over 8 weeks
Pulse Pressure
Mean change from baseline Pulse Pressure in each group
Time frame: Over 8 weeks
Lipid parameters
Percent of Change from baseline
Time frame: 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)
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Emergency Cardiology Center n.a. Acad G Chapidze
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Arkhangelsk, Russia
Сity clinical hospital #1 named after E.E.Volosevich
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Time frame: 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
Time frame: 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%
Time frame: Over 8 weeks
Adverse events and Serious adverse events (SAE)
Emergent Adverse events and Serious adverse events (SAE)
Time frame: Over 8 weeks
Vital signs
Blood pressure (BP)
Time frame: Over 8 weeks
Vital signs
Pulse rate (PR)
Time frame: Over 8 weeks
Vital signs
Respiratory rate (RR)
Time frame: Over 8 weeks
Electrocardiogram
Significant abnormalities observed from ECG
Time frame: Over 8 weeks
Clinical lab tests
Relevant deviations of laboratory test results
Time frame: Over 8 weeks