Arterial HypertensionTRICOLORNCT03722524
The Use of TrIple Fixed-dose Combination in the Treatment of Arterial Hypertension
An observational study of Arterial Hypertension, run by Servier Russia at 51 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Arterial Hypertension
- What is being tested?
- amlodipine / indapamide / perindopril arginine FDC
- How many people
- 1,247 participants
- Where
- 51 sitesRussia
- Study dates
- 1 Oct 2018to 17 Jul 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with uncontrolled arterial hypertension who needs triple antihypertensive combinations in a single tablet
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
Russia51 sites
City Policlinic #3
Al'met'yevsk
City Policlinic # 9
Barnaul
City Policlinic # 7
Belgorod
City Hospital # 2
Bryansk
City Policlinic # 8
Chelyabinsk
City Policlinic # 2
Cherepovets
City Policlinic # 8
Irkutsk
City Policlinic # 5
Ivanovo
City Hospital # 1
Izhevsk
City Policlinic # 18
Kazan'
City Policlinic # 5
Kemerovo
City Policlinic # 15
Khabarovsk
City Policlinic # 2
Kirov
City Policlinic # 7
Krasnoyarsk
City Policlinic # 7
Kursk
FSBI NMIC of Cardiology of the Ministry of Health of Russia
Moscow, 121552
City Policlinic # 70
Moscow
City Policlinic # 2
Murmansk
City Policlinic # 17
Nizhny Novgorod
City Hospital # 2
Novokuznetsk
City Policlinic # 14
Novosibirsk
City Policlinic # 2
Omsk
Clinic PROM-MED
Orenburg
City Policlinic # 2
Oryol
Policlinic of Regional Clinic Hospital
Penza
Medical Center "Alfa-Center"
Perm
City Policlinic # 4
Petrozavodsk
City Policlinic # 3
Pskov
City Policlinic # 42
Rostov-on-Don
City Policlinic # 2
Ryazan
City Policlinic # 27
Saint Petersburg
City Policlinic # 8
Samara
City Policlinic # 2
Saratov
City Policlinic # 2
Sevastopol’
Policlinic of Russian railway
Smolensk
City Policlinic # 2
Stary Oskol
City Policlinic # 3
Syktyvkar
City Policlinic # 6
Tambov
City Policlinic # 2
Tolyatti
City Policlinic # 2
Tomsk
Policlinic VIRMED
Tula
City Policlinic # 3
Tyumen
City Policlinic # 46
Ufa
City Policlinic # 4
Velikiy Novgorod
City Policlinic # 4
Vladimir
City Policlinic # 4
Vladivostok
City Policlinic # 15
Volgograd
City Policlinic # 3
Vologda
City Policlinic # 7
Voronezh
City Policlinic # 1
Yaroslavl
City Policlinic # 3
Yekaterinburg
About this study
Official title: 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"
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.
Read the detailed description
It is multicenter, observational, non-controlled, open-label program. The baseline characteristics will be analyzed in all the patients who started the treatment (intention-to-treat [ITT] population). In case of significant differences between two treatment groups, the baseline characteristics will be provided for both of them.
Changes in the SBP and DBP (with the corresponding confidence intervals) will be assessed in the patients who completed the program without major deviations from protocol (per-protocol population [PPP]).
The analysis of parameters with normal distribution will be performed using the Student's t-test for paired measurements; otherwise the non-parametric Wilcoxon test will be used. The percentage of patients with normalized BP, as well as the percentage of patients who responded to treatment (with 95% confidence intervals), will be calculated.
Questionnaires: The score for each scale will be calculated as the sum of scores for questions constituting the scale.
Assessment of the AEs will be carried out in all the patients who started the treatment (ITT population).
- Conditions
- Arterial Hypertension
- Being tested
- amlodipine / indapamide / perindopril arginine FDC
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amlodipine / indapamide / perindopril arginine FDCDrug
Also called CCB / diuretic / ACE inhibitor
CCB / diuretic / ACE inhibitor
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: amlodipine / indapamide / perindopril arginine FDC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
The assessment of the target office BP levels (SBP <140 mm Hg and DBP <90 mm Hg) was performed in accordance with ESC Guidelines for the management of arterial hypertension (2013)
Measured: 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
Change in the mean score of the of the physical component of the The Short Form (36) Health Survey (SF-36) survey.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: 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
Change in the mean score of the of the physical component of the SF-36 survey Change in the mean score of the of the physical component of the The Short Form (36) Health Survey (SF-36) survey.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start1 Oct 2018
- Primary completion17 Jul 2019
- Study completion17 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servier Russia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natatya LOGUNOVA, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722524
- Sponsor's protocol ID
- IC4-06593-057-RUS
- Acronym
- TRICOLOR
- Status last verified
- May 2021
- First submitted
- 22 Oct 2018
- Last updated
- 10 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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"
- ClinicalTrials.gov ID
- NCT03722524
- Acronym / sponsor ID
- TRICOLOR / IC4-06593-057-RUS
- Conditions
- Arterial Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,247 participants (actual)
- Lead sponsor
- Servier RussiaIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 17 Jul 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 29 Oct 2018 (actual)
- Results
- Posted 30 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It is multicenter, observational, non-controlled, open-label program. The baseline characteristics will be analyzed in all the patients who started the treatment (intention-to-treat [ITT] population). In case of significant differences between two treatment groups, the baseline characteristics will be provided for both of them.
Changes in the SBP and DBP (with the corresponding confidence intervals) will be assessed in the patients who completed the program without major deviations from protocol (per-protocol population [PPP]).
The analysis of parameters with normal distribution will be performed using the Student's t-test for paired measurements; otherwise the non-parametric Wilcoxon test will be used. The percentage of patients with normalized BP, as well as the percentage of patients who responded to treatment (with 95% confidence intervals), will be calculated.
Questionnaires: The score for each scale will be calculated as the sum of scores for questions constituting the scale.
Assessment of the AEs will be carried out in all the patients who started the treatment (ITT population).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with arterial hypertension | – | Drug: amlodipine / indapamide / perindopril arginine FDCThe 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with uncontrolled arterial hypertension who needs triple antihypertensive combinations in a single tablet
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amlodipine / indapamide / perindopril arginine FDCAlso: CCB / diuretic / ACE inhibitorCCB / diuretic / ACE inhibitor | Drug | Patients with arterial hypertension |
Primary outcome
The Mean Systolic BP Changes (mm Hg) at the Visit 4 vs. Baseline
Time frame: Baseline, 3 months
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.
The Mean Diastolic BP Changes (mm Hg) at the Visit 4 vs Baseline.
Time frame: Baseline, 3 months
Changes in the mean office diastolic BP levels (in mm Hg) in the sitting position
3 secondary outcomes
Percentage of Patients Who Achieved the Target Office BP Levels (SBP <140 mm Hg and DBP <90 mm Hg) at Visit 4 vs Baseline
Time frame: 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
Time frame: 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
Time frame: Baseline, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natatya LOGUNOVA study chair
51 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Hypertension, run by Servier Russia at 51 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Mean Systolic BP Changes (mm Hg) at the Visit 4 vs. Baseline (time frame: Baseline, 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.