Twynsta Study With Lifestyle Modifications in Korean Patients With Hypertension
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Purpose
| Condition | Intervention |
|---|---|
|
Hypertension |
Drug: Telmisartan Drug: 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 |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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
- Mean Blood Lipid Change - Triglyceride [ Time Frame: baseline and 24±2 weeks ]Mean blood lipid change - Triglyceride
- Mean Blood Lipid Change - Total Cholesterol [ Time Frame: baseline and 24±2 weeks ]Mean blood lipid change - Total Cholesterol
- 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
- 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
- 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
- Incidence and Severity of Reported Adverse Events. [ Time Frame: 24±2 weeks ]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
Telmisartan 40mg or 80mg
Drug: amlodipine
amlodipine 5mg or 10mg
|
Detailed Description:
Eligibility| Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01316419
Show 55 Study Locations
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
More Information
Additional Information:
| 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: | September 8, 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 |
ClinicalTrials.gov processed this record on May 25, 2017