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Twynsta Study With Lifestyle Modifications in Korean Patients With Hypertension

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ClinicalTrials.gov Identifier: NCT01316419
Recruitment Status : Completed
First Posted : March 16, 2011
Results First Posted : July 27, 2015
Last Update Posted : September 21, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Hypertension Drug: Telmisartan Drug: amlodipine

Detailed Description:
Study Design:

Study Design
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Study Type : Observational
Actual Enrollment : 2089 participants
Time Perspective: Prospective
Official 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
Study Start Date : March 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with essential hypertension Drug: Telmisartan
Telmisartan 40mg or 80mg
Drug: amlodipine
amlodipine 5mg or 10mg


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Korean
Criteria

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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01316419


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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01316419     History of Changes
Other Study ID Numbers: 1235.42
First Posted: March 16, 2011    Key Record Dates
Results First Posted: July 27, 2015
Last Update Posted: September 21, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Amlodipine
Antihypertensive Agents
 Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists