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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04591808
• Other study ID #: CL3-05167-005
• Status: Terminated
• Phase: Phase 3
• Start date: September 9, 2021
• Est. completion date: April 8, 2022

Study information

• Verified date: October 2023
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 146
• Est. completion date: April 8, 2022
• Est. primary completion date: April 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension

Intervention

Drug:
• 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.
• Atorvastatin
1 over-encapsulated atorvastatin 40 mg tablet will be administered once daily each day before breakfast during 8 weeks.
• Perindopril
1 over-encapsulated perindopril 10 mg tablet will be administered once daily each day before breakfast during 8 weeks.

Locations

Country	Name	City	State
Georgia	LTD "Clinic-LJ"	Kutaisi
Georgia	LTD "Marnecore"	Marneuli
Georgia	"Aleksandre Aladashvili Clinic" LLC	Tbilisi
Georgia	Bokhua Memorial Cardiovascular Center	Tbilisi
Georgia	Emergency Cardiology Center n.a. Acad G Chapidze	Tbilisi
Georgia	Israel-Georgian Medical Research Clinic "Helsicore"	Tbilisi
Georgia	Ltd "Digomi Medical Center"	Tbilisi
Georgia	LTD "MediClubGeorgia"	Tbilisi
Russian Federation	?ity clinical hospital #1 named after E.E.Volosevich	Arkhangel'sk
Russian Federation	FSI "Northern Medical Clinical Centre n.a. N.A. Semashko FMBA of Russia"	Arkhangel'sk
Russian Federation	Non-State Institution of Healthcare "Railway Clinical Hospital at station Chelyabinsk of open joint-stock company "Russian Railways"	Chelyabinsk
Russian Federation	Federal State Institution "National Medical Research Center for Preventive Medicine" of the Ministry of Healthcare of the Russian Federation	Moscow
Russian Federation	State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital #51" of Department of Healthcare of Moscow	Moscow
Russian Federation	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
Russian Federation	"Orenburg State Medical University" based on Municipal State healthcare Institution "City Hospital emergency # 1" of the city of Orenburg	Orenburg
Russian Federation	SBHI "Penza Regional Clinical Hospital n.a. N.N. Burdenko"	Penza
Russian Federation	State budgetary institution "Ryazan' regional clinical hospital"	Ryazan'
Russian Federation	GBOU VPO "North-Western State Medical University named after I.I. Mechnikov" , the department faculty and hospital care, court number 5	Saint Petersburg
Russian Federation	LLC "MART" Sankt Petersburg	Saint Petersburg
Russian Federation	Medical Research Institute, LLC	Saint Petersburg
Russian Federation	Saint Petersburg state budgetary institution of healthcare "City policlinic #109"	Saint Petersburg
Russian Federation	Saint-Petersburg GUZ "City Hospital #40 of the Resort District"	Saint Petersburg
Russian Federation	SPB SBHI "City Hospital # 38 n.a. N.A. Semashko"	Saint Petersburg
Russian Federation	SPB SBHI "Pokrovskaya City Hospital"	Saint Petersburg
Russian Federation	St. Petersburg State Budgetary Institution of Healthcare "Diagnostic center #85"	Saint Petersburg
Russian Federation	St. Petersburg State Institution of Health "City Hospital ? 15" Cardiology Care Unit	Saint Petersburg
Russian Federation	Saratov Research Cardiology Institute of Roszdrav	Saratov
Russian Federation	State Budgetary institutionof heath of Tver region "Region clinical hospital"	Tver
Russian Federation	State Institution of Healthcare Vladimir region ''City Hospital ? 4 of Vladimir "	Vladimir
Russian Federation	State Budgetary institution of heath of Yaroslavl region "Regional clinical hospital"	Yaroslavl
Ukraine	Ivano-Frankivsk central city clinical hospital, Cardiology department	Ivano-Frankivs'k
Ukraine	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-Frankivs'k
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 ?AMS of Ukraine, Department of Clinical and Epidemiological Cardiology	Kiev
Ukraine	Medical center ''CONSILIUM MEDICAL''	Kyiv
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	Danylo Halytskyi Lviv National Medical University Department of Therapy No. 1 and Medical Diagnostics of the Faculty of Postgraduate Education	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;	Vinnytsya
Ukraine	Private Small-Scale Enterprise Medical Center "Pulse"	Vinnytsya

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Recherches Internationales Servier	ADIR, a Servier Group company

Countries where clinical trial is conducted

Georgia,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Diastolic blood pressure (DBP)	Mean change from baseline in diastolic blood pressure (DBP) in each group	Over 8 weeks
Secondary	Pulse Pressure	Mean change from baseline Pulse Pressure in each group	Over 8 weeks
Secondary	Lipid parameters	Percent of Change from baseline	Over 8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse events and Serious adverse events (SAE)	Emergent Adverse events and Serious adverse events (SAE)	Over 8 weeks
Secondary	Vital signs	Blood pressure (BP)	Over 8 weeks
Secondary	Vital signs	Pulse rate (PR)	Over 8 weeks
Secondary	Vital signs	Respiratory rate (RR)	Over 8 weeks
Secondary	Electrocardiogram	Significant abnormalities observed from ECG	Over 8 weeks
Secondary	Clinical lab tests	Relevant deviations of laboratory test results	Over 8 weeks

External Links

•   Find Results on Servier Clinical Trial Data website