Essential HypertensionPhase 3NCT05288400

Evaluation of the Clinical Efficacy and Safety of Amlodipine 5mg/ Bisoprolol Fumarate 5mg /Perindopril Arginine 5mg Fixed-dose Combination in Capsule and Free Monotherapy at the Same Dose in Patients With Uncontrolled Essential Hypertension.

A Phase 3 study testing Amlodipine 5mg + bisoprolol fumarate 5mg + perindopril arginine 5mg, Norvasc 5mg tablet and Concor 5mg tablet in people with Essential Hypertension, run by Servier at 15 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to evaluate the efficacy and the safety of a fixed-dose combination in capsule of Amlodipine 5mg/ Bisoprolol fumarate 5mg/ Perindopril arginine 5mg, and free monotherapy at the same dose in patients with uncontrolled essential hypertension. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Essential Hypertension
What is being tested?: Amlodipine 5mg + bisoprolol fumarate 5mg + perindopril arginine 5mg, Norvasc 5mg tablet and Concor 5mg tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 15 sitesRussia
Study dates: 14 May 2018to 18 Dec 2018
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Respect of the previous selection and non-selection criteria.
Confirmed essential uncontrolled HT under patient's current treatment at W000 visit, defined as SBP ≥140 and < 160 mmHg and DBP ≥90 and < 100 mmHg, measured with a validated automatic device in supine position after at least 10 minutes of rest. There were 3 BP measurements at 2-3 minutes of an interval between each measurement. The mean of the two last values of the three measurements was taken.
Normal or without any clinically significant abnormality 12-lead ECG (left ventricular hypertrophy and post-MI ECG-changes are authorized at selection and during the study).
Normal or without clinically significant abnormality of laboratory examinations. Microalbuminuria was authorized.
Non-inclusion criteria :
As per non-selection criteria.

Show all 14Show fewer

Occurrence of an event requiring immediate notification since Selection.
Laboratory results unavailable at the inclusion visit.
Withdrawal of informed consent by patient.
DBP ≥100 mmHg and/or SBP ≥160 mmHg under treatment since the selection visit.
Positive orthostatic test at inclusion.
Positive β-human Chorionic Gonadotrophin (β-HCG) pregnancy test (Blood test).
Laboratory results unavailable at the inclusion visit or clinically significant abnormalities. Macroalbuminuria (>300 mg albumin/24h) was not authorized. ASpartate (Amino)Transferase (ASAT) or ALanine (Amino)Transferase (ALAT) ≥ 2 UNL (Upper Normal Limit) was not authorized.
If all Inclusion and non-inclusion criteria were satisfied, the patient was included and randomized to a treatment group.

Who cannot join

Patients whose BP was still uncontrolled at two consecutive visits (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg) or whose SBP/DBP was above 160/100 mmHg (confirmed with 2 consecutive visits starting W004, at least 14 days apart).
Onset of an adverse event (AE) which required prescription of a treatment incompatible with the protocol.
Onset of an AE which, according to the investigator, makes it unsafe for the patient to continue with the study treatment. This includes clinically significant abnormal biochemical and haematological parameters, or clinically significant ECG abnormality.
Pregnancy.
Major protocol deviation preventing the analysis of the main endpoint, or which, in the opinion of the investigator, makes it unsafe for the patient to continue to take the study medication and to stay in the study.
Non-medical reason (patient's personal decision to stop treatment).

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

Russia15 sites

Regional state budget health care institution "Altai Regional Cardiological dispensary" 46 Malakhova St.
Barnaul, Altayskiy Kray, 656055
Problems of Cardiovascular Diseases" 6 Sosnovy Bulvar St.
Kemerovo, 650002
Autonomous non-profit organization "Medical Center "Alliance" 12 Molodezhnaya St., 12
Kirovsk, 187340
State budgetary healthcare institution of city of Moscow "City polyclinic #2 of Healthcare Department of city of Moscow" 12 Fruktovaya St.
Moscow, 117556
Federal State Budgetary Institution ''Ourpatient clinic #5'' of the Administration of the President of the Russian Federation 14 Plyushchikha St.
Moscow, 119121
St. Petersburg State Budgetary Healthcare Institution "The city hospital No.38. named after N.A. Semashko" 7/2 letter A Gospitalnaya Str., Pushkin
Saint Pertersburg, 196601
Pavlov First Saint Petersburg State Medical University L'va Tolstogo str. 6-8
Saint Pertersburg, 197022
LLC "Medicinskie tekhnologii", Nevzorova street, 6/191025, Saint-Petersburg, Vosstania street, 8 lit A
Saint Petersburg, 192148
LLC "Strategicheskie Medicinskie Sistemy", Nevzorova street, 6
Saint Petersburg, 192148
Saint-Petersburg State Budgetary Healthcare Institution "City outpatient clinic №109" 8 bld. 2 Oleko Dundicha
Saint Petersburg, 192283
Limited Liability Company "Medical Research Institute" 25 Let. A 3 Kolya Tomchak St.
Saint Petersburg, 196084
Federal State Budgetary Institution "North-West Federal Medical Research Center n.a. V.A. Almazov" of the Ministry of Health of the Russian Federation 2 Akkuratova St.
Saint Petersburg, 197341
The Federal State Budgetary Institute "The Nikiforov Russian Center of Emergency and Radiation Medicine" The Ministry of Russian Federation for Civil Defense, Emergencies and Elimination of Consequences of Natural Disasters
Saint Petersburg, 197374
St. Petersburg State Budgetary Healthcare Institution "City Consulting and Diagnostic Center No. 85" 89 bld. 3 Let. A Prospekt Veteranov
Saint Petersburg, 198260
Limited Liability Company "MART" 54 bld. 3 Let. J Maly Prospekt V.O
Saint Petersburg, 1991788

Other trials in Russia

About this study

Official title: Evaluation of the Clinical Efficacy and Safety of Amlodipine 5mg/ Bisoprolol Fumarate 5mg /Perindopril Arginine 5mg Fixed-dose Combination in Capsule and Free Monotherapy at the Same Dose in Patients With Uncontrolled Essential Hypertension. A Multicentre, Randomized, Open-label, 12-weeks Study.

Read the detailed description

This was a phase III, multicenter, randomized, open-label, controlled study, over a 12-week treatment period with a single-capsule of fixed dose combination (FDC) of Amlodipine 5 mg/ Bisoprolol fumarate 5 mg / Perindopril arginine 5 mg and free monocomponents of Amlodipine 5 mg, Bisoprolol fumarate 5 mg and Perindopril arginine 5 mg given concomitantly, in 150 patients with uncontrolled essential HT.

Patients without any non-selection criteria, already treated by anti-hypertensive monotherapy at maximal dose or either by a dual therapy at minimum dose, other than study treatment, having an uncontrolled HT defined by SBP (Systolic Blood Pressure) ≥ 140 and <160 mmHg and DBP (Diastolic Blood Pressure) ≥ 90 and <100 mmHg (in supine position) at 2 different visits (selection and inclusion) were to be selected in this study and randomized to one of two treatment groups: single-capsule combination or free therapy without any wash-out period.

For all patients, controlled blood pressure (BP) was defined as SBP < 140 mmHg and DBP < 90 mmHg.

Conditions: Essential Hypertension
Being tested: Amlodipine 5mg + bisoprolol fumarate 5mg + perindopril arginine 5mg, Norvasc 5mg tablet, Concor 5mg tablet, Coversyl 5mg tablet
Medical subject headings: Essential Hypertension

What participants receive

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

Amlodipine 5mg + bisoprolol fumarate 5mg + perindopril arginine 5mgCombination product
1 capsule/day Oral administration
Norvasc 5mg tabletDrug
Norvasc (amlodipine) 5mg, 1 tablet/day
Concor 5mg tabletDrug
Concor (bisoprolol fumarate) 5mg, 1 tablet/day
Coversyl 5mg tabletDrug
Coversyl (perindopril arginine) 5mg, 1 tablet/day

Study groups in NCT05288400
Study group	Role	What they receive
Group A	Experimental	single-capsule of fixed dosed combination (FDC) of amlodipine 5 mg / bisoprolol fumarate 5 mg / perindopril arginine 5 mg Receives: Combination Product: Amlodipine 5mg + bisoprolol fumarate 5mg + perindopril arginine 5mg
Group B	Active comparator	Free triple therapy of amlodipine 5 mg + bisoprolol fumarate 5 mg + perindopril arginine 5 mg, given concomitantly Receives: Drug: Norvasc 5mg tablet; Drug: Concor 5mg tablet; Drug: Coversyl 5mg tablet

What is being measured

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

Change from baseline of blood pressure (SBP and DBP)
Measured: at baseline, 4, 8 and 12 weeks

Secondary outcomes (3)

Blood pressure control rate (SBP < 140 mmHg and DBP < 90 mmHg)
Measured: at 4, 8 and 12 weeks
Response rate for antihypertensive therapy
Rate of patients with supine blood pressure normalized (SBP <140 mmHg and DBP <90 mmHg) or decrease of SBP ≥20 mmHg and/or decrease of DBP ≥10 mmHg from baseline
Measured: at 4, 8 and 12 weeks
Assessment of patient treatment satisfaction TSQM-9 questionnaire
Measured: 12 weeks

Timeline

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

14 May 201818 Dec 2018

First posted21 Mar 2022
Study start14 May 2018
Primary completion18 Dec 2018
Study completion18 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Essential HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Model description: This was a phase III, multicenter, randomized, open-label, controlled study, over a 12-week treatment period with a single-capsule of fixed dose combination (FDC) of Amlodipine 5 mg/ Bisoprolol fumarate 5 mg / Perindopril arginine 5 mg and free monocomponents of Amlodipine 5 mg, Bisoprolol Fumarate 5 mg and Perindopril arginine 5 mg given concomitantly, in 150 patients with uncontrolled essential HT.
Masking: None (open label)
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05288400
Sponsor's protocol ID: CL3-05166-003
Status last verified: Jun 2025
First submitted: 25 Feb 2022
Last updated: 5 Jun 2025
Results posted: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
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Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension

All Essential Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Clinical Efficacy and Safety of Amlodipine 5mg/ Bisoprolol Fumarate 5mg /Perindopril Arginine 5mg Fixed-dose Combination in Capsule and Free Monotherapy at the Same Dose in Patients With Uncontrolled Essential Hypertension. A Multicentre, Randomized, Open-label, 12-weeks Study.
ClinicalTrials.gov ID: NCT05288400
Acronym / sponsor ID: CL3-05166-003
Conditions: Essential Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: ServierIndustry (pharma, biotech, devices)
Study start: 14 May 2018 (actual)
Primary completion: 18 Dec 2018 (actual)
Study completion: 18 Dec 2018 (actual)
First posted: 21 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

For all patients, controlled blood pressure (BP) was defined as SBP < 140 mmHg and DBP < 90 mmHg.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This was a phase III, multicenter, randomized, open-label, controlled study, over a 12-week treatment period with a single-capsule of fixed dose combination (FDC) of Amlodipine 5 mg/ Bisoprolol fumarate 5 mg / Perindopril arginine 5 mg and free monocomponents of Amlodipine 5 mg, Bisoprolol Fumarate 5 mg and Perindopril arginine 5 mg given concomitantly, in 150 patients with uncontrolled essential HT.

Arm	Type	Receives
Group A	Experimental	Combination Product: Amlodipine 5mg + bisoprolol fumarate 5mg + perindopril arginine 5mgsingle-capsule of fixed dosed combination (FDC) of amlodipine 5 mg / bisoprolol fumarate 5 mg / perindopril arginine 5 mg
Group B	Active comparator	Drug: Norvasc 5mg tablet, Drug: Concor 5mg tablet, Drug: Coversyl 5mg tabletFree triple therapy of amlodipine 5 mg + bisoprolol fumarate 5 mg + perindopril arginine 5 mg, given concomitantly

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Respect of the previous selection and non-selection criteria.
Confirmed essential uncontrolled HT under patient's current treatment at W000 visit, defined as SBP ≥140 and < 160 mmHg and DBP ≥90 and < 100 mmHg, measured with a validated automatic device in supine position after at least 10 minutes of rest. There were 3 BP measurements at 2-3 minutes of an interval between each measurement. The mean of the two last values of the three measurements was taken.
Normal or without any clinically significant abnormality 12-lead ECG (left ventricular hypertrophy and post-MI ECG-changes are authorized at selection and during the study).
Normal or without clinically significant abnormality of laboratory examinations. Microalbuminuria was authorized.
As per non-selection criteria.

Key exclusion criteria (6 listed)

Patients whose BP was still uncontrolled at two consecutive visits (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg) or whose SBP/DBP was above 160/100 mmHg (confirmed with 2 consecutive visits starting W004, at least 14 days apart).
Onset of an adverse event (AE) which required prescription of a treatment incompatible with the protocol.
Onset of an AE which, according to the investigator, makes it unsafe for the patient to continue with the study treatment. This includes clinically significant abnormal biochemical and haematological parameters, or clinically significant ECG abnormality.
Pregnancy.
Major protocol deviation preventing the analysis of the main endpoint, or which, in the opinion of the investigator, makes it unsafe for the patient to continue to take the study medication and to stay in the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Amlodipine 5mg + bisoprolol fumarate 5mg + perindopril arginine 5mg1 capsule/day Oral administration	Combination product	Group A
Norvasc 5mg tabletNorvasc (amlodipine) 5mg, 1 tablet/day	Drug	Group B
Concor 5mg tabletConcor (bisoprolol fumarate) 5mg, 1 tablet/day	Drug	Group B
Coversyl 5mg tabletCoversyl (perindopril arginine) 5mg, 1 tablet/day	Drug	Group B

Primary outcome

Change from baseline of blood pressure (SBP and DBP)
Time frame: at baseline, 4, 8 and 12 weeks

3 secondary outcomes

Blood pressure control rate (SBP < 140 mmHg and DBP < 90 mmHg)
Time frame: at 4, 8 and 12 weeks
Response rate for antihypertensive therapy
Time frame: at 4, 8 and 12 weeks
Assessment of patient treatment satisfaction TSQM-9 questionnaire
Time frame: 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
Individual participant dataSharing planned: 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.

Related trials for Essential Hypertension

Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alexandra Konradi principal investigator

Almazov National Medical Research Centre - Department of Hypertension, Saint Petersburg, Russia

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 inclusion and 6 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: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Russia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from baseline of blood pressure (SBP and DBP) (time frame: at baseline, 4, 8 and 12 weeks). 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 NCT05288400.

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 5 Jun 2025.