Hypertension
Conditions
Brief summary
This observational study is designed to evaluate the effects of Twynsta tablets with life style modifications on blood pressure, quality of life, and other risk factors in Korean patients with hypertension in a routine clinical practice setting.
Detailed description
Study Design:
Interventions
DRUGTelmisartan
Telmisartan 40mg or 80mg
DRUGamlodipine
amlodipine 5mg or 10mg
Sponsors
Boehringer Ingelheim
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with essential hypertension whose blood pressure is not adequately controlled by amlodipine or telmisartan monotherapy (=140/90 mmHg, = 130/80 mmHg for those with diabetes or kidney disease) 2. Age = 19 years at enrollment 3. Male or female patient (or legally acceptable representative) willing and able to provide written informed consent
Exclusion criteria
1. Patients with previous exposure to Twynsta 2. Patients with hypersensitivity to the active substances, or to dihydropyridine derivatives 3. Female patients at second and third trimesters of pregnancy 4. Female patients with lactation 5. Patients with biliary obstructive disorders 6. Patients with severe hepatic impairment 7. Patients with high grade aortic stenosis 8. Patients with shock 9. Patients with hereditary conditions such as intolerance with excipient of the products 10. Current participation in other clinical trials or observational studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Blood Pressure Change Systolic Blood Pressure (SBP) From Baseline After 24±2 Weeks of Treatment or at the Last Observation in Case of Early Withdrawal. | baseline and 24±2 weeks | The primary endpoint is the mean blood pressure change SBP from baseline after 24±2 weeks of treatment or at the last observation in case of early withdrawal. Baseline is defined as data collected on baseline visit. |
| Mean Blood Pressure Change Diastolic Blood Pressure (DBP) From Baseline After 24±2 Weeks of Treatment or at the Last Observation in Case of Early Withdrawal. | baseline and 24±2 weeks | The primary endpoint is the mean blood pressure change DBP from baseline after 24±2 weeks of treatment or at the last observation in case of early withdrawal. Baseline is defined as data collected on baseline visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Achieving SBP Response | 24±2 weeks | Percentage of patients achieving SBP response (defined as mean seated SBP \< 140 mmHg or a drop of ≥ 10 mmHg) is a key secondary endpoint. |
| Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Physical Health Domain | baseline and 24±2 weeks | WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life. The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health. |
| Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Psychological Domain | baseline and 24±2 weeks | WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life. The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health. |
| Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Social Relationships Domain | baseline and 24±2 weeks | WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life. The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health. |
| Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Environment Domain | baseline and 24±2 weeks | WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life. The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health. |
| Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Overall | baseline and 24±2 weeks | WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life. The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health. |
| EuroQol (EQ) Visual Analogue Scale (VAS) | baseline and 24±2 weeks | The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'best imaginable health state' and 'worst imaginable health state. The scale goes from 0 to 100, a low value shows better physical health. |
| Percentage of Patients Achieving SBP/DBP < 130/80 mmHg Among Patients With Diabetes or Kidney Disease | 24±2 weeks | Percentage of patients achieving SBP/DBP \< 130/80 mmHg among patients with diabetes or kidney disease |
| Percentage of Patients Achieving Target Blood Pressure SBP/DBP <140/90 mmHg. | 24±2 weeks | Percentage of patients achieving target blood pressure SBP/DBP \<140/90 mmHg is a key secondary endpoint. |
| Mean Blood Lipid Change - High Density Lipoprotein (HDL)-Cholesterol | baseline and 24±2 weeks | Mean blood lipid change from baseline - high density lipoprotein (HDL)-Cholesterol |
| Mean Blood Lipid Change - Triglyceride | baseline and 24±2 weeks | Mean blood lipid change - Triglyceride |
| Mean Blood Lipid Change - Total Cholesterol | baseline and 24±2 weeks | Mean blood lipid change - Total Cholesterol |
| Percentage of Patients Achieving Normal Body Mass Index (BMI) | 24±2 weeks | Percentage of patients achieving normal BMI (18.5 kg/sq.m to 24.9 kg/sq.m) are presented |
| Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 12±2 Weeks | 12±2 weeks | Percentage of patients who complied with each category of lifestyle modification recommendations at 12±2 weeks |
| Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 24±2 Weeks | 24±2 weeks | Percentage of patients who complied with each category of lifestyle modification recommendations at 12±2 weeks |
| Incidence and Severity of Reported Adverse Events. | 24±2 weeks | Incidence as per the severity of reported adverse events is presented. |
| Mean Blood Lipid Change - Low Density Lipoprotein (LDL)-Cholesterol | baseline and 24±2 weeks | Mean blood lipid change from baseline - low density lipoprotein (LDL)-Cholesterol |
| Percentage of Patients Achieving DBP Response | 24±2 weeks | Percentage of patients achieving DBP response (defined as mean seated DBP \< 90 mmHg or a drop of ≥ 10 mmHg) is a key secondary endpoint. |
Countries
South Korea
Participant flow
Recruitment details
This is an observational study to evaluate the effects of Twynsta tablets (Telmisartan and amlodipine fixed dose combination (FDC), once daily (q.d.)) with life style modifications on blood pressure, quality of life, and other risk factors in Korean patients with hypertension
Participants by arm
| Arm | Count |
|---|---|
| Twynsta (Telmisartan and Amlodipine FDC) Tablets Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg. | 1,824 |
| Total | 1,824 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 19 |
| Overall Study | Not treated | 103 |
| Overall Study | Violated inclusion/exclusion criterion | 143 |
Baseline characteristics
| Characteristic | Twynsta (Telmisartan and Amlodipine FDC) Tablets |
|---|---|
| Age, Continuous | 57.65 years STANDARD_DEVIATION 13.38 |
| Sex: Female, Male Female | 778 Participants |
| Sex: Female, Male Male | 1046 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,824 |
| serious Total, serious adverse events | 33 / 1,824 |
Outcome results
Primary
Mean Blood Pressure Change Diastolic Blood Pressure (DBP) From Baseline After 24±2 Weeks of Treatment or at the Last Observation in Case of Early Withdrawal.
The primary endpoint is the mean blood pressure change DBP from baseline after 24±2 weeks of treatment or at the last observation in case of early withdrawal. Baseline is defined as data collected on baseline visit.
Time frame: baseline and 24±2 weeks
Population: All patients with a baseline and an endpoint blood pressure measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Mean Blood Pressure Change Diastolic Blood Pressure (DBP) From Baseline After 24±2 Weeks of Treatment or at the Last Observation in Case of Early Withdrawal. | -13.48 mmHg | Standard Deviation 11.65 |
p-value: <0.0001Paired t test
Primary
Mean Blood Pressure Change Systolic Blood Pressure (SBP) From Baseline After 24±2 Weeks of Treatment or at the Last Observation in Case of Early Withdrawal.
The primary endpoint is the mean blood pressure change SBP from baseline after 24±2 weeks of treatment or at the last observation in case of early withdrawal. Baseline is defined as data collected on baseline visit.
Time frame: baseline and 24±2 weeks
Population: All patients with a baseline and an endpoint blood pressure measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Mean Blood Pressure Change Systolic Blood Pressure (SBP) From Baseline After 24±2 Weeks of Treatment or at the Last Observation in Case of Early Withdrawal. | -21.81 mmHg | Standard Deviation 16.12 |
p-value: <0.0001Paired t test
Secondary
Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Environment Domain
WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life. The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health.
Time frame: baseline and 24±2 weeks
Population: Patients with a baseline and an endpoint WHOQOL-BREF response
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Environment Domain | 0.12 scores on a scale | Standard Deviation 1.97 |
p-value: 0.0152Paired t test
Secondary
Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Overall
WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life. The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health.
Time frame: baseline and 24±2 weeks
Population: Patients with a baseline and an endpoint WHOQOL-BREF response
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Overall | 0.03 scores on a scale | Standard Deviation 0.37 |
p-value: 0.0013Paired t test
Secondary
Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Physical Health Domain
WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life. The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health.
Time frame: baseline and 24±2 weeks
Population: Patients with a baseline and an endpoint WHOQOL-BREF response
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Physical Health Domain | 0.07 scores on a scale | Standard Deviation 1.69 |
p-value: 0.1099Paired t test
Secondary
Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Psychological Domain
WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life. The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health.
Time frame: baseline and 24±2 weeks
Population: All patients with a baseline and an endpoint blood pressure measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Psychological Domain | 0.11 scores on a scale | Standard Deviation 1.75 |
p-value: 0.0197Paired t test
Secondary
Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Social Relationships Domain
WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life. The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health.
Time frame: baseline and 24±2 weeks
Population: Patients with a baseline and an endpoint WHOQOL-BREF response
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Social Relationships Domain | -0.04 scores on a scale | Standard Deviation 2.31 |
p-value: 0.4543Paired t test
Secondary
EuroQol (EQ) Visual Analogue Scale (VAS)
The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'best imaginable health state' and 'worst imaginable health state. The scale goes from 0 to 100, a low value shows better physical health.
Time frame: baseline and 24±2 weeks
Population: Patients with a baseline and an endpoint EQ VAS response
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | EuroQol (EQ) Visual Analogue Scale (VAS) | 4.64 scores on a scale | Standard Deviation 16.24 |
p-value: <0.0001Paired t test
Secondary
Incidence and Severity of Reported Adverse Events.
Incidence as per the severity of reported adverse events is presented.
Time frame: 24±2 weeks
Population: Patients having received at least one dose of Twynsta tablets
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Incidence and Severity of Reported Adverse Events. | Mild | 220 participants |
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Incidence and Severity of Reported Adverse Events. | Moderate | 73 participants |
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Incidence and Severity of Reported Adverse Events. | Severe | 9 participants |
Secondary
Mean Blood Lipid Change - High Density Lipoprotein (HDL)-Cholesterol
Mean blood lipid change from baseline - high density lipoprotein (HDL)-Cholesterol
Time frame: baseline and 24±2 weeks
Population: Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Mean Blood Lipid Change - High Density Lipoprotein (HDL)-Cholesterol | 0.44 mg/dl | Standard Deviation 6.34 |
p-value: 0.4248Paired t test
Secondary
Mean Blood Lipid Change - Low Density Lipoprotein (LDL)-Cholesterol
Mean blood lipid change from baseline - low density lipoprotein (LDL)-Cholesterol
Time frame: baseline and 24±2 weeks
Population: Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Mean Blood Lipid Change - Low Density Lipoprotein (LDL)-Cholesterol | -9.17 mg/dl | Standard Deviation 29.16 |
p-value: 0.0006Paired t test
Secondary
Mean Blood Lipid Change - Total Cholesterol
Mean blood lipid change - Total Cholesterol
Time frame: baseline and 24±2 weeks
Population: Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Mean Blood Lipid Change - Total Cholesterol | -9.62 mg/dl | Standard Deviation 30.19 |
p-value: 0.0006Paired t-test
Secondary
Mean Blood Lipid Change - Triglyceride
Mean blood lipid change - Triglyceride
Time frame: baseline and 24±2 weeks
Population: Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Mean Blood Lipid Change - Triglyceride | -3.76 mg/dl | Standard Deviation 74.12 |
p-value: 0.5579Paired t test
Secondary
Percentage of Patients Achieving DBP Response
Percentage of patients achieving DBP response (defined as mean seated DBP \< 90 mmHg or a drop of ≥ 10 mmHg) is a key secondary endpoint.
Time frame: 24±2 weeks
Population: All patients with a baseline and an endpoint blood pressure measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Percentage of Patients Achieving DBP Response | 88.99 percentage of participants |
Secondary
Percentage of Patients Achieving Normal Body Mass Index (BMI)
Percentage of patients achieving normal BMI (18.5 kg/sq.m to 24.9 kg/sq.m) are presented
Time frame: 24±2 weeks
Population: Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Percentage of Patients Achieving Normal Body Mass Index (BMI) | 45.62 percentage of participants |
Secondary
Percentage of Patients Achieving SBP/DBP < 130/80 mmHg Among Patients With Diabetes or Kidney Disease
Percentage of patients achieving SBP/DBP \< 130/80 mmHg among patients with diabetes or kidney disease
Time frame: 24±2 weeks
Population: All patients with diabetes, kidney disease or both (diabetes + kidney disease)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Percentage of Patients Achieving SBP/DBP < 130/80 mmHg Among Patients With Diabetes or Kidney Disease | Diabetes (N=269) | 41.26 percentage of participants |
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Percentage of Patients Achieving SBP/DBP < 130/80 mmHg Among Patients With Diabetes or Kidney Disease | Kidney Disease (N=20) | 40.00 percentage of participants |
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Percentage of Patients Achieving SBP/DBP < 130/80 mmHg Among Patients With Diabetes or Kidney Disease | Diabetes + Kidney disease (N=10) | 50.00 percentage of participants |
Secondary
Percentage of Patients Achieving SBP Response
Percentage of patients achieving SBP response (defined as mean seated SBP \< 140 mmHg or a drop of ≥ 10 mmHg) is a key secondary endpoint.
Time frame: 24±2 weeks
Population: All patients with a baseline and an endpoint blood pressure measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Percentage of Patients Achieving SBP Response | 87.18 percentage of participants |
Secondary
Percentage of Patients Achieving Target Blood Pressure SBP/DBP <140/90 mmHg.
Percentage of patients achieving target blood pressure SBP/DBP \<140/90 mmHg is a key secondary endpoint.
Time frame: 24±2 weeks
Population: All patients with a baseline and an endpoint blood pressure measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Percentage of Patients Achieving Target Blood Pressure SBP/DBP <140/90 mmHg. | 74.07 percentage of participants |
Secondary
Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 12±2 Weeks
Percentage of patients who complied with each category of lifestyle modification recommendations at 12±2 weeks
Time frame: 12±2 weeks
Population: Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 12±2 Weeks | Physical activity | 71.87 percentage of participants |
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 12±2 Weeks | Well balanced diet | 84.33 percentage of participants |
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 12±2 Weeks | Dietary sodium reduction | 71.08 percentage of participants |
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 12±2 Weeks | Moderation of alcohol consumption | 82.38 percentage of participants |
Secondary
Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 24±2 Weeks
Percentage of patients who complied with each category of lifestyle modification recommendations at 12±2 weeks
Time frame: 24±2 weeks
Population: Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 24±2 Weeks | Physical activity | 77.21 percentage of participants |
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 24±2 Weeks | Well balanced diet | 87.38 percentage of participants |
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 24±2 Weeks | Dietary sodium reduction | 76.09 percentage of participants |
| Twynsta (Telmisartan and Amlodipine FDC) Tablets | Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 24±2 Weeks | Moderation of alcohol consumption | 83.49 percentage of participants |