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ACTIVE NOT RECRUITING
NCT07876895

Monitoring the Effectiveness and Safety of Antihypertensive Therapy With a Fixed-Dose Combination of Perindopril and Amlodipine in Patients With Uncontrolled Essential Hypertension

Sponsor: Bosnalijek D.D

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

600

Start Date

2025-01-16

Completion Date

2026-10

Last Updated

2026-10-15

Healthy Volunteers

No

Interventions

DRUG

fixed 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)

Locations (1)

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

Sarajevo, Bosnia and Herzegovina