Study Stopped
for strategic reasons
Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia
1 other identifier
interventional
146
3 countries
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2021
Shorter than P25 for phase_3
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedStudy Start
First participant enrolled
September 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 8, 2022
CompletedOctober 18, 2023
October 1, 2023
7 months
September 30, 2020
October 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (14)
Systolic blood pressure (SBP)
Over 8 weeks
Density Lipoprotein Cholesterol (LDLc)
Over 8 weeks
Diastolic blood pressure (DBP)
Over 8 weeks
Pulse Pressure
Over 8 weeks
Lipid parameters
Over 8 weeks
- +9 more secondary outcomes
Study Arms (3)
S05167
EXPERIMENTALLipitor®
ACTIVE COMPARATORCoversyl®
ACTIVE COMPARATORInterventions
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.
1 over-encapsulated atorvastatin 40 mg tablet will be administered once daily each day before breakfast during 8 weeks.
1 over-encapsulated perindopril 10 mg tablet will be administered once daily each day before breakfast during 8 weeks.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- 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.
You may not qualify if:
- Unlikely to cooperate in the study,
- Pregnant and lactating women,
- \. 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,
- 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,
- Patients treated with beta-blockers or alpha-blockers,
- \. Patients with liver disease or renal impairment,
- Certain known cardiovascular diseases or cardiac rhythm disorders,
- Known or suspected symptomatic orthostatic hypotension,
- Familial hypercholesterolemia,
- Secondary hypertension or dyslipidemia,
- Patients who are hypersensitive to atorvastatin, perindopril or to any of the excipients of study drugs,
- Hypersensitivity to any other ACE inhibitor,
- History of angioedema associated with previous ACE inhibitor therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
LTD "Clinic-LJ"
Kutaisi, 46000, Georgia
LTD "Marnecore"
Marneuli, 3000, Georgia
"Aleksandre Aladashvili Clinic" LLC
Tbilisi, 01102, Georgia
Israel-Georgian Medical Research Clinic "Helsicore"
Tbilisi, 01112, Georgia
Bokhua Memorial Cardiovascular Center
Tbilisi, 0159, Georgia
Ltd "Digomi Medical Center"
Tbilisi, 0159, Georgia
LTD "MediClubGeorgia"
Tbilisi, 0160, Georgia
Emergency Cardiology Center n.a. Acad G Chapidze
Tbilisi, 0179, Georgia
FSI "Northern Medical Clinical Centre n.a. N.A. Semashko FMBA of Russia"
Arkhangelsk, 163000, Russia
Сity clinical hospital #1 named after E.E.Volosevich
Arkhangelsk, 163001, Russia
Non-State Institution of Healthcare "Railway Clinical Hospital at station Chelyabinsk of open joint-stock company "Russian Railways"
Chelyabinsk, 454092, Russia
Federal State Institution "National Medical Research Center for Preventive Medicine" of the Ministry of Healthcare of the Russian Federation
Moscow, 101990, 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, 120016, Russia
State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital #51" of Department of Healthcare of Moscow
Moscow, 121309, Russia
"Orenburg State Medical University" based on Municipal State healthcare Institution "City Hospital emergency # 1" of the city of Orenburg
Orenburg, 460040, Russia
SBHI "Penza Regional Clinical Hospital n.a. N.N. Burdenko"
Penza, 440026, Russia
State budgetary institution "Ryazan' regional clinical hospital"
Ryazan, 390039, Russia
Saint Petersburg state budgetary institution of healthcare "City policlinic #109"
Saint Petersburg, 192289, Russia
GBOU VPO "North-Western State Medical University named after I.I. Mechnikov" , the department faculty and hospital care, court number 5
Saint Petersburg, 195067, Russia
Medical Research Institute, LLC
Saint Petersburg, 196084, Russia
SPB SBHI "City Hospital # 38 n.a. N.A. Semashko"
Saint Petersburg, 196600, Russia
Saint-Petersburg GUZ "City Hospital #40 of the Resort District"
Saint Petersburg, 197706, Russia
St. Petersburg State Institution of Health "City Hospital № 15" Cardiology Care Unit
Saint Petersburg, 198205, Russia
St. Petersburg State Budgetary Institution of Healthcare "Diagnostic center #85"
Saint Petersburg, 198260, Russia
SPB SBHI "Pokrovskaya City Hospital"
Saint Petersburg, 199106, Russia
LLC "MART" Sankt Petersburg
Saint Petersburg, 199178, Russia
Saratov Research Cardiology Institute of Roszdrav
Saratov, 410028, Russia
State Budgetary institutionof heath of Tver region "Region clinical hospital"
Tver', 166036, Russia
State Institution of Healthcare Vladimir region ''City Hospital № 4 of Vladimir "
Vladimir, 600020, Russia
State Budgetary institution of heath of Yaroslavl region "Regional clinical hospital"
Yaroslavl, 150062, 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, 76018, 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, 04114, 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, 79059, 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2020
First Posted
October 19, 2020
Study Start
September 9, 2021
Primary Completion
April 8, 2022
Study Completion
April 8, 2022
Last Updated
October 18, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After Marketing Authorisation in EEA or US if the study is used for the approval.
- Access Criteria
- Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.