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DyslipidemiasPhase 3NCT04591808

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

A Phase 3 study testing Atorvastatin/Perindopril, Atorvastatin and Perindopril in people with Dyslipidemias and Hypertension, run by Institut de Recherches Internationales Servier at 43 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Dyslipidemias, Hypertension
What is being tested?
Atorvastatin/Perindopril, Atorvastatin and Perindopril
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
43 sitesin 3 countries
Study dates
9 Sep 2021to 8 Apr 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Unlikely to cooperate in the study,
  • 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,
Show all 15Show fewer
  • 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.

Trial locations and contacts

43 sites in 3 countries.

43 sites in 3 countries

Russia22 sites

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

    Arkhangelsk, 163000

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

    Arkhangelsk, 163001

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

    Chelyabinsk, 454092

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

    Moscow, 101990

  • 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

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

    Moscow, 121309

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

    Orenburg, 460040

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

    Penza, 440026

  • State budgetary institution "Ryazan' regional clinical hospital"

    Ryazan, 390039

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

    Saint Petersburg, 192289

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

    Saint Petersburg, 195067

  • Medical Research Institute, LLC

    Saint Petersburg, 196084

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

    Saint Petersburg, 196600

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

    Saint Petersburg, 197706

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

    Saint Petersburg, 198205

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

    Saint Petersburg, 198260

  • SPB SBHI "Pokrovskaya City Hospital"

    Saint Petersburg, 199106

  • LLC "MART" Sankt Petersburg

    Saint Petersburg, 199178

  • Saratov Research Cardiology Institute of Roszdrav

    Saratov, 410028

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

    Tver', 166036

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

    Vladimir, 600020

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

    Yaroslavl, 150062

Other trials in Russia

Ukraine13 sites

  • 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

  • Ivano-Frankivsk central city clinical hospital, Cardiology department

    Ivano-Frankivsk

  • "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

  • 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

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

    Kiev, 04114

  • Medical center ''CONSILIUM MEDICAL''

    Kyiv

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

    Lviv, 79059

  • 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

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

    Odesa

  • 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

  • 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

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

    Vinnytsia

  • Private Small-Scale Enterprise Medical Center "Pulse"

    Vinnytsia

Other trials in Ukraine

Georgia8 sites

  • LTD "Clinic-LJ"

    Kutaisi, 46000

  • LTD "Marnecore"

    Marneuli, 3000

  • "Aleksandre Aladashvili Clinic" LLC

    Tbilisi, 01102

  • Israel-Georgian Medical Research Clinic "Helsicore"

    Tbilisi, 01112

  • Bokhua Memorial Cardiovascular Center

    Tbilisi, 0159

  • Ltd "Digomi Medical Center"

    Tbilisi, 0159

  • LTD "MediClubGeorgia"

    Tbilisi, 0160

  • Emergency Cardiology Center n.a. Acad G Chapidze

    Tbilisi, 0179

Other trials in Georgia

About this study

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

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.

Being tested
Atorvastatin/Perindopril, Atorvastatin, Perindopril
Keywords
Dyslipidemia, Hypertension, Cardiovascular, Atorvastatin, Perindopril, HMG-CoA reductase inhibitor, ACE inhibitor, Fixed combination
Medical subject headings
Dyslipidemias, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atorvastatin/PerindoprilDrug

    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.

  • AtorvastatinDrug

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

  • PerindoprilDrug

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

Study groups in NCT04591808
Study groupRoleWhat they receive
S05167ExperimentalNot described
Receives: Drug: Atorvastatin/Perindopril
Lipitor®Active comparatorNot described
Receives: Drug: Atorvastatin
Coversyl®Active comparatorNot described
Receives: Drug: Perindopril

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Over 8 weeks

  2. 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)

    Measured: Over 8 weeks

Secondary outcomes (14)

  1. Systolic blood pressure (SBP)

    Mean change from baseline in sitting systolic blood pressure (SBP) in the S05167 group as compared with Coversyl group

    Measured: Over 8 weeks

  2. 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

    Measured: Over 8 weeks

  3. Diastolic blood pressure (DBP)

    Mean change from baseline in diastolic blood pressure (DBP) in each group

    Measured: Over 8 weeks

  4. Pulse Pressure

    Mean change from baseline Pulse Pressure in each group

    Measured: Over 8 weeks

  5. Lipid parameters

    Percent of Change from baseline

    Measured: Over 8 weeks

  6. 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)

    Measured: Over 8 weeks

  7. Blood pressure control

    Percent of blood pressure control: BP< 140/80 mm Hg AND % of blood pressure control: BP < 130/80 mm Hg

    Measured: Over 8 weeks

  8. 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%

    Measured: Over 8 weeks

  9. Adverse events and Serious adverse events (SAE)

    Emergent Adverse events and Serious adverse events (SAE)

    Measured: Over 8 weeks

  10. Vital signs

    Blood pressure (BP)

    Measured: Over 8 weeks

  11. Vital signs

    Pulse rate (PR)

    Measured: Over 8 weeks

  12. Vital signs

    Respiratory rate (RR)

    Measured: Over 8 weeks

  13. Electrocardiogram

    Significant abnormalities observed from ECG

    Measured: Over 8 weeks

  14. Clinical lab tests

    Relevant deviations of laboratory test results

    Measured: Over 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2020
  2. Study start9 Sep 2021
  3. Primary completion8 Apr 2022
  4. Study completion8 Apr 2022

Why it stopped: for strategic reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04591808
Sponsor's protocol ID
CL3-05167-005
Status last verified
Oct 2023
First submitted
30 Sep 2020
Last updated
18 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atorvastatin/Perindopril, Atorvastatin and Perindopril in people with Dyslipidemias and Hypertension, run by Institut de Recherches Internationales Servier at 43 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Russia, Ukraine, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: for strategic reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systolic blood pressure (SBP) (time frame: Over 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04591808.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.

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