Active, not recruitingNCT07876895Updated Oct 15, 2026

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 in Essential Hypertension, sponsored by Bosnalijek D.D. Active, not recruiting at 1 site in Bosnia and Herzegovina. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Bosnalijek D.D · Observational

Updated Oct 15, 2026Newly registeredGo to Updates ↓

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 600
Ages: 18 Years to 75 Years
Sex: All

Study 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. 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 studied

Essential Hypertension

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Essential Hypertension 538

In context

Essential Hypertension

538 studies on the registry are indexed under Essential Hypertension; 76 are open to participants now.

This study's planned enrollment of 600 is below the median of 718 across 73 observational studies indexed under Essential Hypertension.

Browse Essential Hypertension studies →

Lead sponsor

Bosnalijek D.D is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Patients from Bosnia and Herzegovina

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients older than 18 and younger than 75 years
Patients with essential hypertension with blood pressure values ≥ 140/90 mmHg

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 600 participants (estimated)
Patient registry: No

Interventions

Drugfixed combination of perindopril + amlodipine
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 researchers measure

Primary outcomes

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
Time frame: 12 months

Secondary outcomes

Therapy adherence
Evaluation of therapy adherence during therapy with fixed combination of perindopril + amlodipine in patients with essential hypertension
Time frame: 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
Time frame: 12 months

Study locations

1 site

Clinic for diseases of the heart, blood vessels and rheumatism, Clinical Center University of Sarajevo (KCUS)
Sarajevo, 71000, Bosnia and Herzegovina

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

1 registry update since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Oct 2026, 21 months after the start.

Of 26 observational studies under Essential Hypertension, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 52. This study's planned 21 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 9, 2026
First posted: Oct 15, 2026
StartActual: Jan 16, 2025
Primary completionEst.: Oct 2026
CompletionEst.: Oct 2026
Last update: Oct 15, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Registered

First appeared on the registry. No changes since

Oct 15, 2026

Show all 1 update

Oct 15, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07876895
Lead sponsor: Bosnalijek D.D
Responsible party: Sponsor
First posted: Oct 15, 2026
Start date: Jan 16, 2025
Primary completion: Oct 2026 (estimated)
Completion: Oct 2026 (estimated)
Last update: Oct 15, 2026

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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