Twynsta Study With Lifestyle Modifications in Korean Patients With Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01316419
First received: March 15, 2011
Last updated: June 26, 2015
Last verified: June 2015
  Purpose

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 Intervention
Hypertension
Drug: Telmisartan and amlodipine

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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. [ Time Frame: baseline and 24±2 weeks ] [ Designated as safety issue: No ]

    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:
  • Percentage of Patients Achieving Target Blood Pressure SBP/DBP <140/90 mmHg. [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
    Percentage of patients achieving target blood pressure SBP/DBP <140/90 mmHg is a key secondary endpoint.

  • Percentage of Patients Achieving DBP Response [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 24±2 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: baseline and 24±2 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: baseline and 24±2 weeks ] [ Designated as safety issue: No ]

    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)- Environment Domain [ Time Frame: baseline and 24±2 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: baseline and 24±2 weeks ] [ Designated as safety issue: No ]

    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) [ Time Frame: baseline and 24±2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 24±2 weeks ] [ Designated as safety issue: No ]
    Mean blood lipid change from baseline - low density lipoprotein (LDL)-Cholesterol

  • Mean Blood Lipid Change - High Density Lipoprotein (HDL)-Cholesterol [ Time Frame: baseline and 24±2 weeks ] [ Designated as safety issue: No ]
    Mean blood lipid change from baseline - high density lipoprotein (HDL)-Cholesterol

  • Mean Blood Lipid Change - Triglyceride [ Time Frame: baseline and 24±2 weeks ] [ Designated as safety issue: No ]
    Mean blood lipid change - Triglyceride

  • Mean Blood Lipid Change - Total Cholesterol [ Time Frame: baseline and 24±2 weeks ] [ Designated as safety issue: No ]
    Mean blood lipid change - Total Cholesterol

  • Percentage of Patients Achieving Normal Body Mass Index (BMI) [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12±2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
    Percentage of patients who complied with each category of lifestyle modification recommendations at 12±2 weeks

  • Incidence and Severity of Reported Adverse Events. [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
    Incidence as per the severity of reported adverse events is presented.


Enrollment: 2089
Study Start Date: March 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with essential hypertension Drug: Telmisartan and amlodipine
Telmisartan and amlodipine 40/5mg or 40/10mg or 80/5mg

Detailed Description:

Study Design:

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316419

  Hide Study Locations
Locations
Korea, Republic of
Boehringer Ingelheim Investigational Site 55
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 15
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 54
Chonbuk, Korea, Republic of
Boehringer Ingelheim Investigational Site 18
Chonnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 48
Chungcheong, Korea, Republic of
Boehringer Ingelheim Investigational Site 8
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 46
Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 45
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 31
Daejeon, 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
Deagu, Korea, Republic of
Boehringer Ingelheim Investigational Site 44
Gangwon, Korea, Republic of
Boehringer Ingelheim Investigational Site 32
Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 24
Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 21
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 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, Korea, Republic of
Boehringer Ingelheim Investigational Site 5
Gyeonggi do, Korea, Republic of
Boehringer Ingelheim Investigational Site 35
Gyeongnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 51
Jeju, Korea, Republic of
Boehringer Ingelheim Investigational Site 52
Jeju, Korea, Republic of
Boehringer Ingelheim Investigational Site 1
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 12
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 2
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 7
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 3
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 4
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 27
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 10
Ulan, Korea, Republic of
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01316419     History of Changes
Other Study ID Numbers: 1235.42
Study First Received: March 15, 2011
Results First Received: June 26, 2015
Last Updated: June 26, 2015
Health Authority: South Korea: Ministry of Food and Drug Safety (MFDS)

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

ClinicalTrials.gov processed this record on July 30, 2015