Clinical trial NCT01316419: Twynsta Study With Lifestyle Modifications in Korean Patients With Hypertension
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-03-16
Enrollment: 2089
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Korean

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.

Detailed description: Study Design:

Eligibility 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

Primary outcomes:
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.
timeFrame: baseline and 24±2 weeks
measure: 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.
timeFrame: baseline and 24±2 weeks
Secondary outcomes:
measure: Percentage of Patients Achieving Target Blood Pressure SBP/DBP <140/90 mmHg.
timeFrame: 24±2 weeks
measure: Percentage of Patients Achieving DBP Response
timeFrame: 24±2 weeks
measure: Percentage of Patients Achieving SBP Response
timeFrame: 24±2 weeks
measure: Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Physical Health Domain
timeFrame: baseline and 24±2 weeks
measure: Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Psychological Domain
timeFrame: baseline and 24±2 weeks
measure: Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Social Relationships Domain
timeFrame: baseline and 24±2 weeks
measure: Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Environment Domain
timeFrame: baseline and 24±2 weeks
measure: Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Overall
timeFrame: baseline and 24±2 weeks
measure: EuroQol (EQ) Visual Analogue Scale (VAS)
timeFrame: baseline and 24±2 weeks
measure: Percentage of Patients Achieving SBP/DBP < 130/80 mmHg Among Patients With Diabetes or Kidney Disease
timeFrame: 24±2 weeks
measure: Mean Blood Lipid Change - Low Density Lipoprotein (LDL)-Cholesterol
timeFrame: baseline and 24±2 weeks
measure: Mean Blood Lipid Change - High Density Lipoprotein (HDL)-Cholesterol
timeFrame: baseline and 24±2 weeks
measure: Mean Blood Lipid Change - Triglyceride
timeFrame: baseline and 24±2 weeks
measure: Mean Blood Lipid Change - Total Cholesterol
timeFrame: baseline and 24±2 weeks
measure: Percentage of Patients Achieving Normal Body Mass Index (BMI)
timeFrame: 24±2 weeks
measure: Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 12±2 Weeks
timeFrame: 12±2 weeks
measure: Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 24±2 Weeks
timeFrame: 24±2 weeks
measure: Incidence and Severity of Reported Adverse Events.
timeFrame: 24±2 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 15
city: Busan
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 37
city: Busan
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 42
city: Busan
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 55
city: Chonbuk
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 54
city: Chonnam
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 18
city: Chungcheong
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 48
city: Chungnam
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 17
city: Chungnam
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 19
city: Chungnam
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 8
city: Daegu
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 46
city: Daejeon
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 31
city: Daejeon
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 39
city: Daejeon
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 40
city: Daejeon
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 41
city: Daejeon
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 45
city: Deagu
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 14
city: Deagu
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 25
city: Deagu
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 26
city: Gangwon
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 44
city: Gwangju
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 24
city: Gwangju
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 32
city: Gyeonggi do
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 5
city: Gyeonggi
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 11
city: Gyeonggi
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 13
city: Gyeonggi
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 16
city: Gyeonggi
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 21
city: Gyeonggi
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 23
city: Gyeonggi
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 30
city: Gyeonggi
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 43
city: Gyeonggi
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 47
city: Gyeonggi
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 6
city: Gyeonggi
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 9
city: Gyeongnam
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 35
city: Jeju
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 51
city: Jeju
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 52
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 12
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 1
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 20
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 22
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 27
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 28
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 29
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 2
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 33
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 34
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 36
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 38
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 3
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 49
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 4
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 50
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 53
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 7
city: Ulan
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 10
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: