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Twynsta Study With Lifestyle Modifications in Korean Patients With Hypertension

NCT ID: NCT01316419

Last Updated: 2015-09-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2089 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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Study Design:

Conditions

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Hypertension

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with essential hypertension

Telmisartan

Intervention Type DRUG

Telmisartan 40mg or 80mg

amlodipine

Intervention Type DRUG

amlodipine 5mg or 10mg

Interventions

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Telmisartan

Telmisartan 40mg or 80mg

Intervention Type DRUG

amlodipine

amlodipine 5mg or 10mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site 15

Busan, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 37

Busan, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 42

Busan, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 55

Busan, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 54

Chonbuk, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 18

Chonnam, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 48

Chungcheong, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 46

Daegu, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 31

Daejeon, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 39

Daejeon, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 40

Daejeon, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 41

Daejeon, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 45

Daejeon, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 14

Deagu, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 25

Deagu, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 26

Deagu, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 44

Gangwon, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 24

Gwangju, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 32

Gwangju, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 11

Gyeonggi-do, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 13

Gyeonggi-do, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 16

Gyeonggi-do, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 21

Gyeonggi-do, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 23

Gyeonggi-do, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 30

Gyeonggi-do, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 43

Gyeonggi-do, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 47

Gyeonggi-do, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 5

Gyeonggi-do, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 6

Gyeonggi-do, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 9

Gyeonggi-do, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 35

Gyeongnam, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 51

Jeju City, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 52

Jeju City, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 17

Jungnam, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 19

Jungnam, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 8

Jungnam, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 12

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 1

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 20

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 22

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 27

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 28

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 29

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 2

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 33

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 34

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 36

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 38

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 3

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 49

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 4

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 50

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 53

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 7

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 10

Ulan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1235.42

Identifier Type: -

Identifier Source: org_study_id

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