Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients… (NCT04591808) | Clinical Trial Compass
TerminatedPhase 3
Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia
Stopped: for strategic reasons
Georgia146 participantsStarted 2021-09-09
Plain-language summary
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.
Who can participate
Age range18 Years – 79 Years
SexALL
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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.
✓. 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,
✕.Patients treated with \>1 anti-hypertensive drug or \>1 Lipid lowering drug,
✕.Patients previously treated with atorvastatin and/or perindopril,
✕.Known resistance to ACE inhibitors,
✕
What they're measuring
1
Systolic blood pressure (SBP)
Timeframe: Over 8 weeks
2
Low-Density Lipoprotein Cholesterol (LDLc)
Timeframe: Over 8 weeks
Trial details
NCT IDNCT04591808
SponsorInstitut de Recherches Internationales Servier