Twynsta Study With Lifestyle Modifications in Korean Patients With Hypertension

Completed

Conditions: Hypertension

Interventions: Drug: Telmisartan
Drug: amlodipine

Registration Number: NCT01316419

Lead Sponsor: Boehringer Ingelheim

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:

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2089

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with essential hypertension	Telmisartan	-
Patients with essential hypertension	amlodipine	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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
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.
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)- 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
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
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.

Trial Locations

Locations (55): Boehringer Ingelheim Investigational Site 51
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Jeju, Korea, Republic of
Boehringer Ingelheim Investigational Site 54
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Chonbuk, Korea, Republic of
Boehringer Ingelheim Investigational Site 55
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Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 42
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Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 15
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Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 49
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Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 20
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Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 27
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Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 39
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Daejeon, Korea, Republic of
Boehringer Ingelheim Investigational Site 25
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Deagu, Korea, Republic of
Boehringer Ingelheim Investigational Site 37
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Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 18
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Chonnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 48
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Chungcheong, Korea, Republic of
Boehringer Ingelheim Investigational Site 17
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Chungnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 19
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Chungnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 40
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Daejeon, Korea, Republic of
Boehringer Ingelheim Investigational Site 8
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Chungnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 46
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Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 31
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Daejeon, Korea, Republic of
Boehringer Ingelheim Investigational Site 14
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Deagu, Korea, Republic of
Boehringer Ingelheim Investigational Site 26
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Deagu, Korea, Republic of
Boehringer Ingelheim Investigational Site 44
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Gangwon, Korea, Republic of
Boehringer Ingelheim Investigational Site 24
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Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 32
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Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 5
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Gyeonggi do, Korea, Republic of
Boehringer Ingelheim Investigational Site 11
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Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 13
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Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 16
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Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 21
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Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 23
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Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 30
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Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 43
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Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 35
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Gyeongnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 47
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Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 6
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Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 9
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Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 12
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Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 52
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Jeju, Korea, Republic of
Boehringer Ingelheim Investigational Site 1
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Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 22
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Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 28
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Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 29
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Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 33
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Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 2
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Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 36
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Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 34
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Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 3
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Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 38
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Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 4
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Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 10
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Ulan, Korea, Republic of
Boehringer Ingelheim Investigational Site 7
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Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 50
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Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 53
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Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 41
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Daejeon, Korea, Republic of
Boehringer Ingelheim Investigational Site 45
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Daejeon, Korea, Republic of