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

NCT ID: NCT04591808

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-09
• Study Completion Date: 2022-04-08

Brief 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.

Conditions

Dyslipidemias; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

S05167

Group Type: EXPERIMENTAL

Atorvastatin/Perindopril

Intervention Type: DRUG

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.

Lipitor®

Group Type: ACTIVE_COMPARATOR

Atorvastatin

Intervention Type: DRUG

1 over-encapsulated atorvastatin 40 mg tablet will be administered once daily each day before breakfast during 8 weeks.

Coversyl®

Group Type: ACTIVE_COMPARATOR

Perindopril

Intervention Type: DRUG

1 over-encapsulated perindopril 10 mg tablet will be administered once daily each day before breakfast during 8 weeks.

Interventions

Atorvastatin/Perindopril

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.

Intervention Type: DRUG

Atorvastatin

1 over-encapsulated atorvastatin 40 mg tablet will be administered once daily each day before breakfast during 8 weeks.

Intervention Type: DRUG

Perindopril

1 over-encapsulated perindopril 10 mg tablet will be administered once daily each day before breakfast during 8 weeks.

Intervention Type: DRUG

Eligibility Criteria

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,

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ADIR, a Servier Group company

INDUSTRY

Sponsor Role: collaborator

Institut de Recherches Internationales Servier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Non-State Institution of Healthcare "Railway Clinical Hospital at station Chelyabinsk of open joint-stock company "Russian Railways"

Chelyabinsk, , Russia

Federal State Institution "National Medical Research Center for Preventive Medicine" of the Ministry of Healthcare of the Russian Federation

Moscow, , Russia

State Budgetary Institution of Healthcare of the City of Moscow "City Clinical Hospital No. 17 of the Department of Healthcare of the City of Moscow"

Moscow, , Russia

State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital #51" of Department of Healthcare of Moscow

Moscow, , Russia

"Orenburg State Medical University" based on Municipal State healthcare Institution "City Hospital emergency # 1" of the city of Orenburg

Orenburg, , Russia

SBHI "Penza Regional Clinical Hospital n.a. N.N. Burdenko"

Penza, , Russia

State budgetary institution "Ryazan' regional clinical hospital"

Ryazan, , Russia

Saint Petersburg state budgetary institution of healthcare "City policlinic #109"

Saint Petersburg, , Russia

GBOU VPO "North-Western State Medical University named after I.I. Mechnikov" , the department faculty and hospital care, court number 5

Saint Petersburg, , Russia

Medical Research Institute, LLC

Saint Petersburg, , Russia

SPB SBHI "City Hospital # 38 n.a. N.A. Semashko"

Saint Petersburg, , Russia

Saint-Petersburg GUZ "City Hospital #40 of the Resort District"

Saint Petersburg, , Russia

St. Petersburg State Institution of Health "City Hospital № 15" Cardiology Care Unit

Saint Petersburg, , Russia

St. Petersburg State Budgetary Institution of Healthcare "Diagnostic center #85"

Saint Petersburg, , Russia

SPB SBHI "Pokrovskaya City Hospital"

Saint Petersburg, , Russia

LLC "MART" Sankt Petersburg

Saint Petersburg, , Russia

Saratov Research Cardiology Institute of Roszdrav

Saratov, , Russia

State Budgetary institutionof heath of Tver region "Region clinical hospital"

Tver', , Russia

State Institution of Healthcare Vladimir region ''City Hospital № 4 of Vladimir "

Vladimir, , Russia

State Budgetary institution of heath of Yaroslavl region "Regional clinical hospital"

Yaroslavl, , Russia

State Higher Educational Institution "Ivano-Frankivsk National Medical University", Chair of Internal Medicine #2 and Nursing based on Communal Institution Ivano-Frankivsk Regional Clinical Cardiological Center, Chronic Ischaemic Heart Disease Department

Ivano-Frankivsk, , Ukraine

Ivano-Frankivsk central city clinical hospital, Cardiology department

Ivano-Frankivsk, , Ukraine

"L.T. Malaya Therapy National Institute of the National Institute of Medical Science of Ukraine" Department of aging and prevention of metabolic-associated diseases

Kharkiv, , Ukraine

The Training and Research Medical Complex "The University Clinic" of the Kharkiv National Medical University, Department of Therapy, National Pharmaceutical University, Chair of Pharmacotherapy

Kharkiv, , Ukraine

State Institution "Institute of gerontology named after D.F. Chebotaryov НAMS of Ukraine, Department of Clinical and Epidemiological Cardiology

Kiev, , Ukraine

Medical center ''CONSILIUM MEDICAL''

Kyiv, , Ukraine

Danylo Halytskyi Lviv National Medical University Department of Therapy No. 1 and Medical Diagnostics of the Faculty of Postgraduate Education

Lviv, , Ukraine

Chair of Propedeutic of Internal Medicine #1 of Danylo Halytsky Lviv National Medical University based Municipal Non-profit Enterprise "Lviv City Clinical Hospital #5" Out-patient department.

Lviv, , Ukraine

The Medical and Diagnostic Center of LLC "House of Medicine"

Odesa, , Ukraine

Chair of Internal Medicine #3 of Ternopil National Medical University named after I. Gorbachevsky of MOH of Ukraine based on Outpatient Department of Municipal Institution of Ternopil Regional Council "Ternopil University Hospital",

Ternopil, , Ukraine

Communal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council, Department of Rheumatology, I. Horbachevsky Ternopil National Medical University of MOH of Ukraine, Chair of Internal Medicine #2

Ternopil, , Ukraine

Municipal Non-profit Institution "Vinnytsya City Clinical Hospital #1", Therapeutical department; National Pirogov Memorial University, Vinnytsya, Chair of Propedeutics of Internal Medicine;

Vinnytsia, , Ukraine

Private Small-Scale Enterprise Medical Center "Pulse"

Vinnytsia, , Ukraine

Countries

Georgia; Russia; Ukraine

Study Documents

Document Type: Individual Participant Data Set

View Document

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Document Type: Clinical Study Report

View Document

Document Type: [study-level clinical trial data]

View Document

Related Links

https://clinicaltrials.servier.com/

Find Results on Servier Clinical Trial Data website

Other Identifiers

CL3-05167-005

Identifier Type: -

Identifier Source: org_study_id