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.
Study Design:
Study Type
OBSERVATIONAL
Enrollment
2,089
Telmisartan 40mg or 80mg
amlodipine 5mg or 10mg
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
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
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
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
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
Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Physical Health Domain
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Boehringer Ingelheim Investigational Site 15
Busan, South Korea
Boehringer Ingelheim Investigational Site 37
Busan, South Korea
Boehringer Ingelheim Investigational Site 42
Busan, South Korea
Boehringer Ingelheim Investigational Site 55
Busan, South Korea
Boehringer Ingelheim Investigational Site 54
Chonbuk, South Korea
Boehringer Ingelheim Investigational Site 18
Chonnam, South Korea
Boehringer Ingelheim Investigational Site 48
Chungcheong, South Korea
Boehringer Ingelheim Investigational Site 46
Daegu, South Korea
Boehringer Ingelheim Investigational Site 31
Daejeon, South Korea
Boehringer Ingelheim Investigational Site 39
Daejeon, South Korea
...and 45 more locations
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
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
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
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
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
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
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
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
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
Mean Blood Lipid Change - Triglyceride
Mean blood lipid change - Triglyceride
Time frame: baseline and 24±2 weeks
Mean Blood Lipid Change - Total Cholesterol
Mean blood lipid change - Total Cholesterol
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24±2 weeks
Incidence and Severity of Reported Adverse Events.
Incidence as per the severity of reported adverse events is presented.
Time frame: 24±2 weeks