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Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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

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

NCT04591808•Institut de Recherches Internationales Servier

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 79 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Men or women from 18 to 79 years old who can comply with the study requirements and timetable,
•2. 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.
•3. 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

•1. Unlikely to cooperate in the study,
•2. 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,
+5 more criteria

Locations (43)

LTD "Clinic-LJ"

Kutaisi, Georgia

LTD "Marnecore"

Marneuli, Georgia

"Aleksandre Aladashvili Clinic" LLC

Tbilisi, Georgia

Israel-Georgian Medical Research Clinic "Helsicore"

Tbilisi, Georgia

Bokhua Memorial Cardiovascular Center

Tbilisi, Georgia

Ltd "Digomi Medical Center"

Tbilisi, Georgia

LTD "MediClubGeorgia"

Tbilisi, Georgia

Emergency Cardiology Center n.a. Acad G Chapidze

Tbilisi, Georgia

FSI "Northern Medical Clinical Centre n.a. N.A. Semashko FMBA of Russia"

Arkhangelsk, Russia

Сity clinical hospital #1 named after E.E.Volosevich

Arkhangelsk, Russia

Key Dates

Start Date

September 9, 2021

Primary Completion Date

April 8, 2022

Completion Date

April 8, 2022

Last Updated

October 18, 2023

Enrollment

146

ACTUAL participants

Conditions

DyslipidemiasHypertension

Interventions

Atorvastatin/Perindopril

DRUG

Atorvastatin

DRUG

Perindopril

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

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