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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amlodipine / indapamide / perindopril arginine FDC | Drug | CCB / diuretic / ACE inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline, 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with uncontrolled arterial hypertension who needs triple antihypertensive combinations in a single tablet
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| Name | Affiliation | Role |
|---|---|---|
| Natatya LOGUNOVA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City Policlinic #3 | Al'met'yevsk | Russia | ||||
| City Policlinic # 9 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. amlodipine / indapamide / perindopril arginine FDC: CCB / diuretic / ACE inhibitor |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2018 |
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| 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. |
| 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. | Baseline, 3 months |
| 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. amlodipine / indapamide / perindopril arginine FDC: CCB / diuretic / ACE inhibitor |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | No gender was indicated for 10 patients | Count of Participants | Participants |
| |||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Patients with arterial hypertension | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mm Hg | Baseline, 3 months |
|
|
| ||||||||||||||||||||||||||
| Primary | 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 | Posted | Mean | Standard Deviation | mm Hg | Baseline, 3 months |
|
| |||||||||||||||||||||||||||
| 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 | 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) | Posted | Number | 95% Confidence Interval | percentage of patients | Baseline, 3 months |
|
| |||||||||||||||||||||||||||
| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months |
|
| |||||||||||||||||||||||||||
| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months |
|
|
10 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. amlodipine / indapamide / perindopril arginine FDC: CCB / diuretic / ACE inhibitor | 0 | 1,148 | 3 | 1,148 | 9 | 1,148 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| tooth abscess | Immune system disorders | Systematic Assessment | for which the surgical treatment was performed |
| |
| exacerbation of chronic pyelonephritis | Immune system disorders | Systematic Assessment | which was stopped by administration of antibiotics) |
| |
| unstable angina | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| arterial hypotension with BP of 80/50 mm Hg and weakness | Vascular disorders | Systematic Assessment |
| ||
| treatment inefficacy | Vascular disorders | Systematic Assessment |
| ||
| unstable angina | Vascular disorders | Systematic Assessment |
| ||
| cough | Cardiac disorders | Systematic Assessment |
| ||
| arterial hypotension | Vascular disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natalya LOGUNOVA | AO Servier | +7 495 9370700 | Natalya.LOGUNOVA@servier.com |
| Dec 4, 2020 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 25, 2018 | Dec 4, 2020 | ICF_001.pdf |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| D007190 | Indapamide |
| D002121 | Calcium Channel Blockers |
| D004232 | Diuretics |
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000077264 | Calcium-Regulating Hormones and Agents |
| D045505 | Physiological Effects of Drugs |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D045283 | Natriuretic Agents |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
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| >=65 years |
|
| Male |
|
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
| Participants |
|
|