N/A
N=1,247
The Use of TrIple Fixed-dose Combination in the Treatment of Arterial Hypertension
Arterial Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT03722524 ↗Enrolled (actual)
1,247
Serious AEs
0.3%
Results posted
Mar 2021
Primary outcome: Primary: The Mean Systolic BP Changes (mm Hg) at the Visit 4 vs. Baseline — 33.47 mm Hg
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- amlodipine / indapamide / perindopril arginine FDC (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Servier Russia
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Mean Systolic BP Changes (mm Hg) at the Visit 4 vs. Baseline |
33.47 | — |
| PRIMARY The Mean Diastolic BP Changes (mm Hg) at the Visit 4 vs Baseline. |
14.34 | — |
| SECONDARY Percentage of Patients Who Achieved the Target Office BP Levels (SBP <140 mm Hg and DBP <90 mm Hg) at Visit 4 vs Baseline |
93.38 | — |
| SECONDARY The Mean Standardized Score of the Physical Component of the Quality of Life Questionnaire The Short Form (36) Health Survey at Visit 4 vs Baseline |
13.64 | — |
| SECONDARY The Mean Standardized Score of the Mental Component of the Quality of Life Questionnaire The Short Form (36) Health Survey at Visit 4 vs Baseline |
23.57 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03722524). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.