Twynsta Study With Lifestyle Modifications in Korean Patients With Hypertension

An observational study of Hypertension, run by Boehringer Ingelheim at 55 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Hypertension
What is being tested?: Telmisartan and amlodipine
How many people: 2,089 participants
Where: 55 sitesSouth Korea
Study dates: Mar 2011to Jun 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Korean

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

55 sites in 1 country.

City, postcode or hospital

55 sites in 1 country

South Korea55 sites

Boehringer Ingelheim Investigational Site 15
Busan
Boehringer Ingelheim Investigational Site 37
Busan
Boehringer Ingelheim Investigational Site 42
Busan
Boehringer Ingelheim Investigational Site 55
Busan
Boehringer Ingelheim Investigational Site 54
Chonbuk
Boehringer Ingelheim Investigational Site 18
Chonnam
Boehringer Ingelheim Investigational Site 48
Chungcheong
Boehringer Ingelheim Investigational Site 46
Daegu
Boehringer Ingelheim Investigational Site 31
Daejeon
Boehringer Ingelheim Investigational Site 39
Daejeon
Boehringer Ingelheim Investigational Site 40
Daejeon
Boehringer Ingelheim Investigational Site 41
Daejeon
Boehringer Ingelheim Investigational Site 45
Daejeon
Boehringer Ingelheim Investigational Site 14
Deagu
Boehringer Ingelheim Investigational Site 25
Deagu
Boehringer Ingelheim Investigational Site 26
Deagu
Boehringer Ingelheim Investigational Site 44
Gangwon
Boehringer Ingelheim Investigational Site 24
Gwangju
Boehringer Ingelheim Investigational Site 32
Gwangju
Boehringer Ingelheim Investigational Site 11
Gyeonggi-do
Boehringer Ingelheim Investigational Site 13
Gyeonggi-do
Boehringer Ingelheim Investigational Site 16
Gyeonggi-do
Boehringer Ingelheim Investigational Site 21
Gyeonggi-do
Boehringer Ingelheim Investigational Site 23
Gyeonggi-do
Boehringer Ingelheim Investigational Site 30
Gyeonggi-do
Boehringer Ingelheim Investigational Site 43
Gyeonggi-do
Boehringer Ingelheim Investigational Site 47
Gyeonggi-do
Boehringer Ingelheim Investigational Site 5
Gyeonggi-do
Boehringer Ingelheim Investigational Site 6
Gyeonggi-do
Boehringer Ingelheim Investigational Site 9
Gyeonggi-do
Boehringer Ingelheim Investigational Site 35
Gyeongnam
Boehringer Ingelheim Investigational Site 51
Jeju City
Boehringer Ingelheim Investigational Site 52
Jeju City
Boehringer Ingelheim Investigational Site 17
Jungnam
Boehringer Ingelheim Investigational Site 19
Jungnam
Boehringer Ingelheim Investigational Site 8
Jungnam
Boehringer Ingelheim Investigational Site 12
Seoul
Boehringer Ingelheim Investigational Site 1
Seoul
Boehringer Ingelheim Investigational Site 20
Seoul
Boehringer Ingelheim Investigational Site 22
Seoul
Boehringer Ingelheim Investigational Site 27
Seoul
Boehringer Ingelheim Investigational Site 28
Seoul
Boehringer Ingelheim Investigational Site 29
Seoul
Boehringer Ingelheim Investigational Site 2
Seoul
Boehringer Ingelheim Investigational Site 33
Seoul
Boehringer Ingelheim Investigational Site 34
Seoul
Boehringer Ingelheim Investigational Site 36
Seoul
Boehringer Ingelheim Investigational Site 38
Seoul
Boehringer Ingelheim Investigational Site 3
Seoul
Boehringer Ingelheim Investigational Site 49
Seoul
Boehringer Ingelheim Investigational Site 4
Seoul
Boehringer Ingelheim Investigational Site 50
Seoul
Boehringer Ingelheim Investigational Site 53
Seoul
Boehringer Ingelheim Investigational Site 7
Seoul
Boehringer Ingelheim Investigational Site 10
Ulan

Other trials in South Korea

About this study

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

Read the detailed description

Study Design:

Conditions: Hypertension
Being tested: Telmisartan, amlodipine
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TelmisartanDrug
Telmisartan 40mg or 80mg
amlodipineDrug
amlodipine 5mg or 10mg

Study groups in NCT01316419
Study group	Role	What they receive
Patients with essential hypertension		Not described Receives: Drug: Telmisartan; Drug: amlodipine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
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.
Measured: baseline and 24±2 weeks
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.
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.
Measured: baseline and 24±2 weeks

Secondary outcomes (18)

Percentage of Patients Achieving Target Blood Pressure SBP/DBP <140/90 mmHg.
Percentage of patients achieving target blood pressure SBP/DBP <140/90 mmHg is a key secondary endpoint.
Measured: 24±2 weeks
Percentage of Patients Achieving DBP Response
Percentage of patients achieving DBP response (defined as mean seated DBP < 90 mmHg or a drop of ≥ 10 mmHg) is a key secondary endpoint.
Measured: 24±2 weeks
Percentage of Patients Achieving SBP Response
Percentage of patients achieving SBP response (defined as mean seated SBP < 140 mmHg or a drop of ≥ 10 mmHg) is a key secondary endpoint.
Measured: 24±2 weeks
Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Physical Health Domain
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.
Measured: baseline and 24±2 weeks
Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Psychological Domain
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.
Measured: baseline and 24±2 weeks
Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Social Relationships Domain
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.
Measured: baseline and 24±2 weeks
Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Environment Domain
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.
Measured: baseline and 24±2 weeks
Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Overall
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.
Measured: baseline and 24±2 weeks
EuroQol (EQ) Visual Analogue Scale (VAS)
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.
Measured: baseline and 24±2 weeks
Percentage of Patients Achieving SBP/DBP < 130/80 mmHg Among Patients With Diabetes or Kidney Disease
Percentage of patients achieving SBP/DBP < 130/80 mmHg among patients with diabetes or kidney disease
Measured: 24±2 weeks
Mean Blood Lipid Change - Low Density Lipoprotein (LDL)-Cholesterol
Mean blood lipid change from baseline - low density lipoprotein (LDL)-Cholesterol
Measured: baseline and 24±2 weeks
Mean Blood Lipid Change - High Density Lipoprotein (HDL)-Cholesterol
Mean blood lipid change from baseline - high density lipoprotein (HDL)-Cholesterol
Measured: baseline and 24±2 weeks
Mean Blood Lipid Change - Triglyceride
Mean blood lipid change - Triglyceride
Measured: baseline and 24±2 weeks
Mean Blood Lipid Change - Total Cholesterol
Mean blood lipid change - Total Cholesterol
Measured: baseline and 24±2 weeks
Percentage of Patients Achieving Normal Body Mass Index (BMI)
Percentage of patients achieving normal BMI (18.5 kg/sq.m to 24.9 kg/sq.m) are presented
Measured: 24±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 12±2 weeks
Measured: 12±2 weeks
Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 24±2 Weeks
Percentage of patients who complied with each category of lifestyle modification recommendations at 12±2 weeks
Measured: 24±2 weeks
Incidence and Severity of Reported Adverse Events.
Incidence as per the severity of reported adverse events is presented.
Measured: 24±2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Jun 2014

First posted16 Mar 2011 (estimated)
Study startMar 2011
Primary completionJun 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 2,089 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01316419
Sponsor's protocol ID: 1235.42
Status last verified: Sep 2015
First submitted: 15 Mar 2011
Last updated: 21 Sep 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01316419
Acronym / sponsor ID: 1235.42
Conditions: Hypertension
Study type: Observational
Recruitment status: Completed
Enrolment: 2,089 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 16 Mar 2011 (estimated)
Results: Posted 27 Jul 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Design:

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with essential hypertension	–	Drug: Telmisartan, Drug: amlodipine

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Korean

Key inclusion criteria (3 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TelmisartanTelmisartan 40mg or 80mg	Drug	Patients with essential hypertension
amlodipineamlodipine 5mg or 10mg	Drug	Patients with essential hypertension

Primary outcome

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.

18 secondary outcomes

Percentage of Patients Achieving Target Blood Pressure SBP/DBP <140/90 mmHg.
Time frame: 24±2 weeks
Percentage of Patients Achieving DBP Response
Time frame: 24±2 weeks
Percentage of Patients Achieving SBP Response
Time frame: 24±2 weeks
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
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
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
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
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
EuroQol (EQ) Visual Analogue Scale (VAS)
Time frame: baseline and 24±2 weeks
Percentage of Patients Achieving SBP/DBP < 130/80 mmHg Among Patients With Diabetes or Kidney Disease
Time frame: 24±2 weeks
Mean Blood Lipid Change - Low Density Lipoprotein (LDL)-Cholesterol
Time frame: baseline and 24±2 weeks
Mean Blood Lipid Change - High Density Lipoprotein (HDL)-Cholesterol
Time frame: baseline and 24±2 weeks
Mean Blood Lipid Change - Triglyceride
Time frame: baseline and 24±2 weeks
Mean Blood Lipid Change - Total Cholesterol
Time frame: baseline and 24±2 weeks
Percentage of Patients Achieving Normal Body Mass Index (BMI)
Time frame: 24±2 weeks
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 24±2 Weeks
Time frame: 24±2 weeks
Incidence and Severity of Reported Adverse Events.
Time frame: 24±2 weeks

Results and safety

Results posted to the registry on 27 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Twynsta (Telmisartan and Amlodipine FDC) Tablets	2,089	1,824

Primary outcome: 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. Mean (Standard Deviation). Unit: mmHg

Measure	Twynsta (Telmisartan and Amlodipine FDC) Tablets n = 1662
Value	-21.81 (16.12)

Twynsta (Telmisartan and Amlodipine FDC) Tablets: p <0.0001, Paired t test

Population analysed: All patients with a baseline and an endpoint blood pressure measurement.

Primary outcome: 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. Mean (Standard Deviation). Unit: mmHg

Measure	Twynsta (Telmisartan and Amlodipine FDC) Tablets n = 1662
Value	-13.48 (11.65)

Twynsta (Telmisartan and Amlodipine FDC) Tablets: p <0.0001, Paired t test

Population analysed: All patients with a baseline and an endpoint blood pressure measurement.

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Twynsta (Telmisartan and Amlodipine FDC) Tablets	33 of 1,824 (1.8%)	0 of 1,824 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Hypertension

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

55 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, run by Boehringer Ingelheim at 55 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01316419.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2015.