Twynsta Study With Lifestyle Modifications in Korean Patients With Hypertension

Study Overview
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Brief Summary
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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
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Study Design:

Official Title
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An Observational Study to Evaluate the Effects of Twynsta Tablets (Telmisartan and Amlodipine FDC, q.d.) With Life Style Modifications on Blood Pressure, Quality of Life, and Other Risk Factors in Korean Patients With Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Telmisartan
* Drug: amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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) Age = 19 years at enrollment Male or female patient (or legally acceptable representative) willing and able to provide written informed consent Exclusion criteria: Patients with previous exposure to Twynsta Patients with hypersensitivity to the active substances, or to dihydropyridine derivatives Female patients at second and third trimesters of pregnancy Female patients with lactation Patients with biliary obstructive disorders Patients with severe hepatic impairment Patients with high grade aortic stenosis Patients with shock Patients with hereditary conditions such as intolerance with excipient of the products Current participation in other clinical trials or observational studies

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with essential hypertension<br> | Drug: Telmisartan<br>* Telmisartan 40mg or 80mg<br>Drug: amlodipine<br>* amlodipine 5mg or 10mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline and 24±2 weeks | 
| 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. | baseline and 24±2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24±2 weeks | 
| 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. | 24±2 weeks | 
| 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. | 24±2 weeks | 
| 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. | baseline and 24±2 weeks | 
| 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. | baseline and 24±2 weeks | 
| 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. | baseline and 24±2 weeks | 
| 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. | baseline and 24±2 weeks | 
| 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. | baseline and 24±2 weeks | 
| 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. | baseline and 24±2 weeks | 
| 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 | 24±2 weeks | 
| Mean Blood Lipid Change - Low Density Lipoprotein (LDL)-Cholesterol | Mean blood lipid change from baseline - low density lipoprotein (LDL)-Cholesterol | baseline and 24±2 weeks | 
| Mean Blood Lipid Change - High Density Lipoprotein (HDL)-Cholesterol | Mean blood lipid change from baseline - high density lipoprotein (HDL)-Cholesterol | baseline and 24±2 weeks | 
| Mean Blood Lipid Change - Triglyceride | Mean blood lipid change - Triglyceride | baseline and 24±2 weeks | 
| Mean Blood Lipid Change - Total Cholesterol | Mean blood lipid change - Total Cholesterol | baseline and 24±2 weeks | 
| 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 | 24±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 12±2 weeks | 12±2 weeks | 
| 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 | 24±2 weeks | 
| Incidence and Severity of Reported Adverse Events. | Incidence as per the severity of reported adverse events is presented. | 24±2 weeks |