Trial Outcomes & Findings for The Use of TrIple Fixed-dose Combination in the Treatment of Arterial Hypertension (NCT NCT03722524)
NCT ID: NCT03722524
Last Updated: 2021-06-10
Results Overview
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.
COMPLETED
1247 participants
Baseline, 3 months
2021-06-10
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
1247
|
|
Overall Study
COMPLETED
|
1148
|
|
Overall Study
NOT COMPLETED
|
99
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Protocol Violation
|
86
|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Reason is not stated
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Patient's decision (refusal to continue participation)
|
3
|
Baseline Characteristics
No gender was indicated for 10 patients
Baseline characteristics by cohort
| Measure |
Patients With Arterial Hypertension
n=1148 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1148 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
810 Participants
n=1148 Participants
|
|
Age, Categorical
>=65 years
|
338 Participants
n=1148 Participants
|
|
Age, Continuous
|
59.24 years
STANDARD_DEVIATION 10.48 • n=1148 Participants
|
|
Sex: Female, Male
Female
|
687 Participants
n=1138 Participants • No gender was indicated for 10 patients
|
|
Sex: Female, Male
Male
|
451 Participants
n=1138 Participants • No gender was indicated for 10 patients
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1148 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1148 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1148 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1148 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=1148 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1148 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1148 Participants
n=1148 Participants
|
|
Region of Enrollment
Russia
|
1148 participants
n=1148 Participants
|
|
Patients with arterial hypertension
|
1148 Participants
n=1148 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsChanges 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.
Outcome measures
| Measure |
Patients With Arterial Hypertension
n=1148 Participants
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
|
|---|---|
|
The Mean Systolic BP Changes (mm Hg) at the Visit 4 vs. Baseline
|
33.47 mm Hg
Standard Deviation 11.70
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsChanges in the mean office diastolic BP levels (in mm Hg) in the sitting position
Outcome measures
| Measure |
Patients With Arterial Hypertension
n=1148 Participants
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
|
|---|---|
|
The Mean Diastolic BP Changes (mm Hg) at the Visit 4 vs Baseline.
|
14.34 mm Hg
Standard Deviation 8.63
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsThe 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)
Outcome measures
| Measure |
Patients With Arterial Hypertension
n=1148 Participants
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
|
|---|---|
|
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 percentage of patients
Interval 91.74 to 94.72
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsChange 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.
Outcome measures
| Measure |
Patients With Arterial Hypertension
n=1148 Participants
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
|
|---|---|
|
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 score on a scale
Standard Deviation 18.06
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsChange 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.
Outcome measures
| Measure |
Patients With Arterial Hypertension
n=1148 Participants
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
|
|---|---|
|
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 score on a scale
Standard Deviation 13.79
|
Adverse Events
Patients With Arterial Hypertension
Serious adverse events
| Measure |
Patients With Arterial Hypertension
n=1148 participants at risk
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
|
|---|---|
|
Immune system disorders
tooth abscess
|
0.09%
1/1148 • Number of events 1 • 10 months
|
|
Immune system disorders
exacerbation of chronic pyelonephritis
|
0.09%
1/1148 • Number of events 1 • 10 months
|
|
Vascular disorders
unstable angina
|
0.09%
1/1148 • Number of events 1 • 10 months
|
Other adverse events
| Measure |
Patients With Arterial Hypertension
n=1148 participants at risk
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
|
|---|---|
|
Vascular disorders
arterial hypotension with BP of 80/50 mm Hg and weakness
|
0.09%
1/1148 • Number of events 1 • 10 months
|
|
Vascular disorders
treatment inefficacy
|
0.09%
1/1148 • Number of events 1 • 10 months
|
|
Vascular disorders
unstable angina
|
0.09%
1/1148 • Number of events 1 • 10 months
|
|
Cardiac disorders
cough
|
0.44%
5/1148 • Number of events 5 • 10 months
|
|
Vascular disorders
arterial hypotension
|
0.09%
1/1148 • Number of events 1 • 10 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place