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

March 15, 2011
June 26, 2015
March 2011
June 2014   (final data collection date for primary outcome measure)
  • 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.

The primary endpoint is the mean blood pressure change systolic blood pressure/diastolic blood pressure(SBP/DBP) from baseline after 24±2 weeks of treatment or at the last observation in case of early withdrawal (i.e. last observation carried forward). [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01316419 on ClinicalTrials.gov Archive Site
  • 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.
  • The key secondary endpoints include the percentage of patients achieving target blood pressure SBP/DBP <140/90 mmHg. [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The key secondary endpoints include the percentage of patients achieving DBP response (defined as mean seated DBP < 90 mmHg or a drop of = 10 mmHg). [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The key secondary endpoints include the percentage of patients achieving SBP response (defined as mean seated SBP < 140 mmHg or a drop of = 10 mmHg). [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The key secondary endpoints include the change from baseline of quality of life assessment data measured by World Health Organization Quality of Life Assessment Instrument (WHOQOL-BREF) and EuroQol Visual Analogue Scale (EQ VAS). [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The other secondary endpoints include the mean blood lipid change (High Density Lipoprotein Cholesterol, Low Density Lipoprotein Cholesterol, Triglycerides, and Total Cholesterol). [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The other secondary endpoints include the percentage of patients achieving normal Body Mass Index (18.5 kg/m2 to 24.9 kg/m2). [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The other secondary endpoints include the percentage of patients who completely complied, partially complied, or who did not comply with lifestyle modification recommendations. [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • Safety will be evaluated by the incidence and severity of reported adverse events. [ Time Frame: 54±2 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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 Design:

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Korean

Hypertension
Drug: Telmisartan and amlodipine
Telmisartan and amlodipine 40/5mg or 40/10mg or 80/5mg
Patients with essential hypertension
Intervention: Drug: Telmisartan and amlodipine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2089
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01316419
1235.42
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP