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Completed

NCT Number: NCT01316419

Twynsta Study With Lifestyle Modifications 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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site 15, Busan, South Korea

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About this study

Study Design:

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telmisartan

Drug

Telmisartan 40mg or 80mg

Amlodipine

Drug

amlodipine 5mg or 10mg

Primary outcomes

  1. 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.

    Time frame: 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.

  2. 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.

    Time frame: 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 outcomes

  1. Percentage of Patients Achieving Target Blood Pressure SBP/DBP <140/90 mmHg.

    Time frame: 24±2 weeks

    Percentage of patients achieving target blood pressure SBP/DBP <140/90 mmHg is a key secondary endpoint.

  2. Percentage of Patients Achieving DBP Response

    Time frame: 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.

  3. Percentage of Patients Achieving SBP Response

    Time frame: 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.

  4. Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Physical Health Domain

    Time frame: 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.

  5. Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Psychological Domain

    Time frame: 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.

  6. Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Social Relationships Domain

    Time frame: 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.

  7. Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Environment Domain

    Time frame: 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.

  8. Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Overall

    Time frame: 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.

  9. EuroQol (EQ) Visual Analogue Scale (VAS)

    Time frame: 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.

  10. Percentage of Patients Achieving SBP/DBP < 130/80 mmHg Among Patients With Diabetes or Kidney Disease

    Time frame: 24±2 weeks

    Percentage of patients achieving SBP/DBP < 130/80 mmHg among patients with diabetes or kidney disease

  11. Mean Blood Lipid Change - Low Density Lipoprotein (LDL)-Cholesterol

    Time frame: baseline and 24±2 weeks

    Mean blood lipid change from baseline - low density lipoprotein (LDL)-Cholesterol

  12. Mean Blood Lipid Change - High Density Lipoprotein (HDL)-Cholesterol

    Time frame: baseline and 24±2 weeks

    Mean blood lipid change from baseline - high density lipoprotein (HDL)-Cholesterol

  13. Mean Blood Lipid Change - Triglyceride

    Time frame: baseline and 24±2 weeks

    Mean blood lipid change - Triglyceride

  14. Mean Blood Lipid Change - Total Cholesterol

    Time frame: baseline and 24±2 weeks

    Mean blood lipid change - Total Cholesterol

  15. Percentage of Patients Achieving Normal Body Mass Index (BMI)

    Time frame: 24±2 weeks

    Percentage of patients achieving normal BMI (18.5 kg/sq.m to 24.9 kg/sq.m) are presented

  16. 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 12±2 weeks

  17. Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 24±2 Weeks

    Time frame: 24±2 weeks

    Percentage of patients who complied with each category of lifestyle modification recommendations at 12±2 weeks

  18. Incidence and Severity of Reported Adverse Events.

    Time frame: 24±2 weeks

    Incidence as per the severity of reported adverse events is presented.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 16, 2011
Registry last updated
Sep 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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