Twynsta Study With Lifestyle Modifications in Korean Patients With Hypertension

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

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 Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Telmisartan; Drug: amlodipine

Detailed Description

Study Design:

• Study Type: Observational
• Enrollment (Actual): 2089

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Korean

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with essential hypertension	Drug: Telmisartan; Telmisartan 40mg or 80mg; Drug: amlodipine; amlodipine 5mg or 10mg

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: March 15, 2011
• First Submitted That Met QC Criteria: March 15, 2011
• First Posted (Estimate): March 16, 2011

Study Record Updates

• Last Update Posted (Estimate): September 21, 2015
• Last Update Submitted That Met QC Criteria: September 8, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Telmisartan
• Other Study ID Numbers: 1235.42