Clinical trial NCT04591808: Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Dyslipidemias
Hypertension
Keywords: Dyslipidemia
Hypertension
Cardiovascular
Atorvastatin
Perindopril
HMG-CoA reductase inhibitor
ACE inhibitor
Fixed combination
Lead sponsor: Servier
Sponsor class: INDUSTRY
Collaborators: name: ADIR, a Servier Group company
First posted: 2020-10-19
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Systolic blood pressure (SBP)
timeFrame: Over 8 weeks
measure: Low-Density Lipoprotein Cholesterol (LDLc)
timeFrame: Over 8 weeks
Secondary outcomes:
measure: Systolic blood pressure (SBP)
timeFrame: Over 8 weeks
measure: Density Lipoprotein Cholesterol (LDLc)
timeFrame: Over 8 weeks
measure: Diastolic blood pressure (DBP)
timeFrame: Over 8 weeks
measure: Pulse Pressure
timeFrame: Over 8 weeks
measure: Lipid parameters
timeFrame: Over 8 weeks
measure: Blood pressure response
timeFrame: Over 8 weeks
measure: Blood pressure control
timeFrame: Over 8 weeks
measure: Lipids control
timeFrame: Over 8 weeks
measure: Adverse events and Serious adverse events (SAE)
timeFrame: Over 8 weeks
measure: Vital signs
timeFrame: Over 8 weeks
measure: Vital signs
timeFrame: Over 8 weeks
measure: Vital signs
timeFrame: Over 8 weeks
measure: Electrocardiogram
timeFrame: Over 8 weeks
measure: Clinical lab tests
timeFrame: Over 8 weeks
Other outcomes:
Locations:
city: Kutaisi
country: Georgia
facility: LTD "Clinic-LJ"
city: Marneuli
country: Georgia
facility: LTD "Marnecore"
city: Tbilisi
country: Georgia
facility: "Aleksandre Aladashvili Clinic" LLC
city: Tbilisi
country: Georgia
facility: Israel-Georgian Medical Research Clinic "Helsicore"
city: Tbilisi
country: Georgia
facility: Bokhua Memorial Cardiovascular Center
city: Tbilisi
country: Georgia
facility: Ltd "Digomi Medical Center"
city: Tbilisi
country: Georgia
facility: LTD "MediClubGeorgia"
city: Tbilisi
country: Georgia
facility: Emergency Cardiology Center n.a. Acad G Chapidze
city: Arkhangel'sk
country: Russian Federation
facility: FSI "Northern Medical Clinical Centre n.a. N.A. Semashko FMBA of Russia"
city: Arkhangel'sk
country: Russian Federation
facility: Сity clinical hospital #1 named after E.E.Volosevich
city: Chelyabinsk
country: Russian Federation
facility: Non-State Institution of Healthcare "Railway Clinical Hospital at station Chelyabinsk of open joint-stock company "Russian Railways"
city: Moscow
country: Russian Federation
facility: Federal State Institution "National Medical Research Center for Preventive Medicine" of the Ministry of Healthcare of the Russian Federation
city: Moscow
country: Russian Federation
facility: 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"
city: Moscow
country: Russian Federation
facility: State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital #51" of Department of Healthcare of Moscow
city: Orenburg
country: Russian Federation
facility: "Orenburg State Medical University" based on Municipal State healthcare Institution "City Hospital emergency # 1" of the city of Orenburg
city: Penza
country: Russian Federation
facility: SBHI "Penza Regional Clinical Hospital n.a. N.N. Burdenko"
city: Ryazan'
country: Russian Federation
facility: State budgetary institution "Ryazan' regional clinical hospital"
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg state budgetary institution of healthcare "City policlinic #109"
city: Saint Petersburg
country: Russian Federation
facility: GBOU VPO "North-Western State Medical University named after I.I. Mechnikov" , the department faculty and hospital care, court number 5
city: Saint Petersburg
country: Russian Federation
facility: Medical Research Institute, LLC
city: Saint Petersburg
country: Russian Federation
facility: SPB SBHI "City Hospital # 38 n.a. N.A. Semashko"
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg GUZ "City Hospital #40 of the Resort District"
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Institution of Health "City Hospital № 15" Cardiology Care Unit
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Institution of Healthcare "Diagnostic center #85"
city: Saint Petersburg
country: Russian Federation
facility: SPB SBHI "Pokrovskaya City Hospital"
city: Saint Petersburg
country: Russian Federation
facility: LLC "MART" Sankt Petersburg
city: Saratov
country: Russian Federation
facility: Saratov Research Cardiology Institute of Roszdrav
city: Tver
country: Russian Federation
facility: State Budgetary institutionof heath of Tver region "Region clinical hospital"
city: Vladimir
country: Russian Federation
facility: State Institution of Healthcare Vladimir region ''City Hospital № 4 of Vladimir "
city: Yaroslavl
country: Russian Federation
facility: State Budgetary institution of heath of Yaroslavl region "Regional clinical hospital"
city: Ivano-Frankivs'k
country: Ukraine
facility: 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
city: Ivano-Frankivs'k
country: Ukraine
facility: Ivano-Frankivsk central city clinical hospital, Cardiology department
city: Kharkiv
country: Ukraine
facility: "L.T. Malaya Therapy National Institute of the National Institute of Medical Science of Ukraine" Department of aging and prevention of metabolic-associated diseases
city: Kharkiv
country: Ukraine
facility: The Training and Research Medical Complex "The University Clinic" of the Kharkiv National Medical University, Department of Therapy, National Pharmaceutical University, Chair of Pharmacotherapy
city: Kiev
country: Ukraine
facility: State Institution "Institute of gerontology named after D.F. Chebotaryov НAMS of Ukraine, Department of Clinical and Epidemiological Cardiology
city: Kyiv
country: Ukraine
facility: Medical center ''CONSILIUM MEDICAL''
city: Lviv
country: Ukraine
facility: Danylo Halytskyi Lviv National Medical University Department of Therapy No. 1 and Medical Diagnostics of the Faculty of Postgraduate Education
city: Lviv
country: Ukraine
facility: 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.
city: Odesa
country: Ukraine
facility: The Medical and Diagnostic Center of LLC "House of Medicine"
city: Ternopil'
country: Ukraine
facility: 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",
city: Ternopil'
country: Ukraine
facility: 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
city: Vinnytsya
country: Ukraine
facility: Municipal Non-profit Institution "Vinnytsya City Clinical Hospital #1", Therapeutical department; National Pirogov Memorial University, Vinnytsya, Chair of Propedeutics of Internal Medicine;
city: Vinnytsya
country: Ukraine
facility: Private Small-Scale Enterprise Medical Center "Pulse"
Study officials:
References: