NCT07876895Active, not recruiting
Monitoring the Effectiveness and Safety of Antihypertensive Therapy With a Fixed-Dose Combination of Perindopril and Amlodipine in Patients With Uncontrolled Essential Hypertension
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 9 Oct 2026
- Start date
- Jan 2025
- Primary completion date
- Oct 2026
- Lead sponsor
- Bosnalijek D.D
- Diseases
- High blood pressure
- NCT number
- NCT07876895
What you commit to
- Study type: Observational
- Planned participants: 600
- From Jan 2025 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Development of serious adverse events requiring discontinuation of therapy
Other illness
- Hypersensitivity to the components of the drug
- Positive history of angioneurotic edema
- 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
- 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 another disease that affects the course of research
Lab values
- Simultaneous use with drugs containing aliskiren in patients with diabetes mellitus or with renal impairment (GFR \<60 ml/min/1.73 m2)
Other
- 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
- Simultaneous use with sacubitril/valsartan
- Patients with primary hyperaldosteronism
- Severe liver damage
- Withdrawal Criteria:
- Occurrence of pregnancy
Who the study is looking for
- Patients older than 18 and younger than 75 years
- Patients with essential hypertension with blood pressure values ≥ 140/90 mmHg
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinic for diseases of the heart, blood vessels and rheumatism, Clinical Center University of Sarajevo (KCUS) Coordinator of this site? Confirm its status | Sarajevo | Bosnia and Herzegovina | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.