The Use of TrIple Fixed-dose Combination in the Treatment of Arterial Hypertension
TRICOLOR
Multinational Observational Uncontrolled Open Programme "The Use of TRIple Fixed-dose COmbination in the Treatment of arteriaL Hypertension: Opportunity for Effective BP Control With cOmbined Antihypertensive Therapy"
1 other identifier
observational
1,247
1 country
51
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2018
Shorter than P25 for all trials
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2018
CompletedFirst Submitted
Initial submission to the registry
October 22, 2018
CompletedFirst Posted
Study publicly available on registry
October 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2019
CompletedResults Posted
Study results publicly available
March 30, 2021
CompletedJune 10, 2021
May 1, 2021
10 months
October 22, 2018
December 4, 2020
May 27, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
The Mean Systolic BP Changes (mm Hg) at the Visit 4 vs. Baseline
Changes in the mean office systolic BP levels (in mm Hg) in the sitting position Blood pressure was measured in accordance with the guidelines of the European Society of Hypertension (ESH) using the auscultatory or oscillometric method and a semi-automated sphygmomanometer. Before taking measurements, the patient remained in a sitting position for 3-5 minutes. Blood pressure was determined on each arm, and the arm with the highest value was taken as the reference. Measurements were taken thrice in the sitting position of a patient, and the average of the second and third BP measurements on the reference arm with an interval of at least 1-2 minutes was recorded.
Baseline, 3 months
The Mean Diastolic BP Changes (mm Hg) at the Visit 4 vs Baseline.
Changes in the mean office diastolic BP levels (in mm Hg) in the sitting position
Baseline, 3 months
Secondary Outcomes (3)
Percentage of Patients Who Achieved the Target Office BP Levels (SBP <140 mm Hg and DBP <90 mm Hg) at Visit 4 vs Baseline
Baseline, 3 months
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
Baseline, 3 months
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
Baseline, 3 months
Study Arms (1)
Patients with arterial hypertension
The patient is included in the program if prior to the study his/her doctor decided to adjust treatment, targeted at the BP control improvement, by prescription of a triple FDC of amlodipine / indapamide / perindopril arginine. The prescription of the triple FDC of amlodipine / indapamide / perindopril arginine during the program is made by the doctor's decision according to the instructions for medical use of this FDC. Presumably, each doctor will include 4 patients in average. It is planned to include 1,300 patients.
Interventions
CCB / diuretic / ACE inhibitor
Eligibility Criteria
Patients with uncontrolled arterial hypertension who needs triple antihypertensive combinations in a single tablet
You may qualify if:
- Age 18 to 79 years
- Essential hypertension
- Patient's consent to participate in the program
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Servier Russialead
Study Sites (51)
City Policlinic #3
Al'met'yevsk, Russia
City Policlinic # 9
Barnaul, Russia
City Policlinic # 7
Belgorod, Russia
City Hospital # 2
Bryansk, Russia
City Policlinic # 8
Chelyabinsk, Russia
City Policlinic # 2
Cherepovets, Russia
City Policlinic # 8
Irkutsk, Russia
City Policlinic # 5
Ivanovo, Russia
City Hospital # 1
Izhevsk, Russia
City Policlinic # 18
Kazan', Russia
City Policlinic # 5
Kemerovo, Russia
City Policlinic # 15
Khabarovsk, Russia
City Policlinic # 2
Kirov, Russia
City Policlinic # 7
Krasnoyarsk, Russia
City Policlinic # 7
Kursk, Russia
FSBI NMIC of Cardiology of the Ministry of Health of Russia
Moscow, 121552, Russia
City Policlinic # 70
Moscow, Russia
City Policlinic # 2
Murmansk, Russia
City Policlinic # 17
Nizhny Novgorod, Russia
City Hospital # 2
Novokuznetsk, Russia
City Policlinic # 14
Novosibirsk, Russia
City Policlinic # 2
Omsk, Russia
Clinic PROM-MED
Orenburg, Russia
City Policlinic # 2
Oryol, Russia
Policlinic of Regional Clinic Hospital
Penza, Russia
Medical Center "Alfa-Center"
Perm, Russia
City Policlinic # 4
Petrozavodsk, Russia
City Policlinic # 3
Pskov, Russia
City Policlinic # 42
Rostov-on-Don, Russia
City Policlinic # 2
Ryazan, Russia
City Policlinic # 27
Saint Petersburg, Russia
City Policlinic # 8
Samara, Russia
City Policlinic # 2
Saratov, Russia
City Policlinic # 2
Sevastopol’, Russia
Policlinic of Russian railway
Smolensk, Russia
City Policlinic # 2
Stary Oskol, Russia
City Policlinic # 3
Syktyvkar, Russia
City Policlinic # 6
Tambov, Russia
City Policlinic # 2
Tolyatti, Russia
City Policlinic # 2
Tomsk, Russia
Policlinic VIRMED
Tula, Russia
City Policlinic # 3
Tyumen, Russia
City Policlinic # 46
Ufa, Russia
City Policlinic # 4
Veliky Novgorod, Russia
City Policlinic # 4
Vladimir, Russia
City Policlinic # 4
Vladivostok, Russia
City Policlinic # 15
Volgograd, Russia
City Policlinic # 3
Vologda, Russia
City Policlinic # 7
Voronezh, Russia
City Policlinic # 1
Yaroslavl, Russia
City Policlinic # 3
Yekaterinburg, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Natalya LOGUNOVA
- Organization
- AO Servier
Study Officials
- STUDY CHAIR
Natatya LOGUNOVA
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2018
First Posted
October 29, 2018
Study Start
October 1, 2018
Primary Completion
July 17, 2019
Study Completion
July 17, 2019
Last Updated
June 10, 2021
Results First Posted
March 30, 2021
Record last verified: 2021-05