The Use of TrIple Fixed-dose Combination in the Treatment of Arterial Hypertension (NCT03722524) | Clinical Trial Compass
CompletedNot Applicable
The Use of TrIple Fixed-dose Combination in the Treatment of Arterial Hypertension
Russia1,247 participantsStarted 2018-10-01
Plain-language summary
The use of TRIple fixed-dose COmbination in the treatment of arteriaL hypertension: opportunity for effective BP control with cOmbined antihypertensive therapy.
The main aim of this study to assess the antihypertensive effectiveness effect on the 24-hour BP profile, as well as tolerability of and compliance to the treatment with a triple FDC of amlodipine / indapamide / perindopril arginine in hypertensive patients in the real clinical practice.
Type of program: Multicenter, observational, non-controlled, open-label program.
Investigators: Cardiologists and outpatient (primary care) physicians (general practitioners).
Number of patients: 1,300 hypertensive patients.
Who can participate
Age range
18 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 to 79 years
* Essential hypertension
* Patient's consent to participate in the program
* Doctor's decision to prescribe FDC of amlodipine / indapamide / perindopril arginine, according to the instruction for use, prior to the inclusion in the program.
Exclusion Criteria:
* Symptomatic, or secondary arterial hypertension
* Office BP ≥ 180/110 mm Hg on treatment (at V0 visit)
* History of myocardial infarction, unstable angina, or cerebrovascular accident within the past 1 year
* CHF of class III-IV NYHA
* Type I diabetes or decompensated type 2 diabetes
* Diseases with severe organ dysfunction (hepatic failure, renal failure, etc.)
* Contraindications to or known intolerance of dihydropyridine calcium channel blockers (including amlodipine) and/or indapamide and/or ACE inhibitors (including perindopril) and/or their fixed combination
* Inability to understand the nature of the program and/or to follow the doctor's recommendations, including ones for the BP self-monitoring.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Mean Systolic BP Changes (mm Hg) at the Visit 4 vs. Baseline
Timeframe: Baseline, 3 months
2
The Mean Diastolic BP Changes (mm Hg) at the Visit 4 vs Baseline.