Essential HypertensionNCT07876895
Monitoring the Effectiveness and Safety of Antihypertensive Therapy With a Fixed-Dose Combination of Perindopril and Amlodipine in Patients With Uncontrolled Essential Hypertension
An observational study of Essential Hypertension, run by Bosnalijek D.D at 1 site in Bosnia and Herzegovina.
Trial summary
The aim of this observational study is to monitor the effectiveness of therapy, adherence and safety of a fixed combination of perindopril + amlodipine in patients with essential hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- fixed combination of perindopril + amlodipine
- Type of treatment
- Pill or oral medicine
- How many people
- 600 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 16 Jan 2025to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from Bosnia and Herzegovina
Who may be able to join
- Patients older than 18 and younger than 75 years
- Patients with essential hypertension with blood pressure values ≥ 140/90 mmHg
Who cannot join
- Hypersensitivity to the components of the drug
- Positive history of angioneurotic edema
- Pregnancy
- Breastfeeding
- Patients who are planning to become pregnant in the near future
- Significant bilateral renal artery stenosis or renal artery stenosis in one functional kidney
Show all 18Show fewer
- Severe hypotension
- Obstruction of the outflow tract of the left ventricle of the heart (eg, high-grade aortic stenosis)
- Hemodynamically unstable heart failure after acute myocardial infarction
- Simultaneous use with drugs containing aliskiren in patients with diabetes mellitus or with renal impairment (GFR <60 ml/min/1.73 m2)
- Simultaneous use with sacubitril/valsartan
- Patients with primary hyperaldosteronism
- Severe liver damage
- Withdrawal Criteria:
- Deterioration of the clinical picture of the underlying disease that requires discontinuation of the study therapy and the introduction of additional diuretic therapy with indapamide and/or hospitalization
- Development of serious adverse events requiring discontinuation of therapy
- Occurrence of pregnancy
- Development of another disease that affects the course of research
Trial locations and contacts
1 site in 1 country.
Bosnia and Herzegovina1 site
Clinic for diseases of the heart, blood vessels and rheumatism, Clinical Center University of Sarajevo (KCUS)
Sarajevo, 71000
About this study
The aim of this observational study is to monitor the effectiveness of therapy, adherence and safety of a fixed combination of perindopril + amlodipine in patients with essential hypertension. The main questions it aims to answer are:
- What is the proportion of patients who achieved reduction of blood pressure to normal values according to ESC guidelines or reduction of systolic pressure by 10 to 15 mmHg and diastolic pressure by 5 to 10 mmHg?
- What is therapy adherence during therapy with fixed combination of perindopril + amlodipine in patients with essential hypertension?
- What is the frequency and types of adverse reactions during therapy with fixed combination of perindopril + amlodipine in patients with essential hypertension? Participants will be followed for twelve months through five measurements (baseline and one, three, six and twelve months after baseline). Values of heart rate and blood pressure, laboratory data (neutrophils, platelets, triglycerides, total cholesterol, HDL, LDL, AST, ALT, urea, creatinine, sodium, potassium, blood glucose), therapy adherence, adverse drug reactions and concomitant therapy will be recorded at each visit.
- Conditions
- Essential Hypertension
- Being tested
- fixed combination of perindopril + amlodipine
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fixed combination of perindopril + amlodipineDrug
Once daily application of fixed combination of perindopril + amlodipine (AMLOPRESSIN® 4mg/ 5mg, tablets AMLOPRESSIN® 4mg/ 10mg, tablets AMLOPRESSIN® 8mg/ 5mg, tablets AMLOPRESSIN® 8mg/ 10mg, tablets)
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapy effectiveness
Monitoring the effectiveness of therapy with the aim of reducing blood pressure to normal values according to 2018 ESC/ESH Guidelines for the Management of Arterial Hypertension or to reducing systolic pressure by 10 to 15 mmHg and diastolic pressure by 5 to 10 mmHg
Measured: 12 months
Secondary outcomes (2)
Therapy adherence
Evaluation of therapy adherence during therapy with fixed combination of perindopril + amlodipine in patients with essential hypertension
Measured: 12 months
Therapy safety
Monitoring the frequency and types of adverse reactions during therapy with fixed combination of perindopril + amlodipine in patients with essential hypertension
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start16 Jan 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bosnalijek D.D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876895
- Sponsor's protocol ID
- AML-01-PMI
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Effectiveness and Safety of Antihypertensive Therapy With a Fixed-Dose Combination of Perindopril and Amlodipine in Patients With Uncontrolled Essential Hypertension
- ClinicalTrials.gov ID
- NCT07876895
- Acronym / sponsor ID
- AML-01-PMI
- Conditions
- Essential Hypertension
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Bosnalijek D.DIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 15 Oct 2026 (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.
The aim of this observational study is to monitor the effectiveness of therapy, adherence and safety of a fixed combination of perindopril + amlodipine in patients with essential hypertension. The main questions it aims to answer are:
- What is the proportion of patients who achieved reduction of blood pressure to normal values according to ESC guidelines or reduction of systolic pressure by 10 to 15 mmHg and diastolic pressure by 5 to 10 mmHg?
- What is therapy adherence during therapy with fixed combination of perindopril + amlodipine in patients with essential hypertension?
- What is the frequency and types of adverse reactions during therapy with fixed combination of perindopril + amlodipine in patients with essential hypertension? Participants will be followed for twelve months through five measurements (baseline and one, three, six and twelve months after baseline). Values of heart rate and blood pressure, laboratory data (neutrophils, platelets, triglycerides, total cholesterol, HDL, LDL, AST, ALT, urea, creatinine, sodium, potassium, blood glucose), therapy adherence, adverse drug reactions and concomitant therapy will be recorded at each visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from Bosnia and Herzegovina
Key inclusion criteria (2 listed)
- Patients older than 18 and younger than 75 years
- Patients with essential hypertension with blood pressure values ≥ 140/90 mmHg
Key exclusion criteria (18 listed)
- Hypersensitivity to the components of the drug
- Positive history of angioneurotic edema
- Pregnancy
- Breastfeeding
- Patients who are planning to become pregnant in the near future
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 |
|---|---|---|
| fixed combination of perindopril + amlodipineOnce daily application of fixed combination of perindopril + amlodipine (AMLOPRESSIN® 4mg/ 5mg, tablets AMLOPRESSIN® 4mg/ 10mg, tablets AMLOPRESSIN® 8mg/ 5mg, tablets AMLOPRESSIN® 8mg/ 10mg, tablets) | Drug | – |
Primary outcome
Therapy effectiveness
Time frame: 12 months
Monitoring the effectiveness of therapy with the aim of reducing blood pressure to normal values according to 2018 ESC/ESH Guidelines for the Management of Arterial Hypertension or to reducing systolic pressure by 10 to 15 mmHg and diastolic pressure by 5 to 10 mmHg
2 secondary outcomes
Therapy adherence
Time frame: 12 months
Therapy safety
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Hypertension, run by Bosnalijek D.D at 1 site in Bosnia and Herzegovina.
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 2 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bosnia and Herzegovina. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Therapy effectiveness (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.