Twynsta Study With Lifestyle Modifications in Korean Patients With Hypertension

NCT01316419 | Completed Results

• 1 other identifier: 1235.42
• Study Type: observational
• Target: 2,089
• Locations: 1 country
• Sites: 55

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  baseline and 24±2 weeks

Secondary Outcomes (18)

• Percentage of Patients Achieving Target Blood Pressure SBP/DBP <140/90 mmHg.

  24±2 weeks

• Percentage of Patients Achieving DBP Response

  24±2 weeks

• Percentage of Patients Achieving SBP Response

  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

  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

  baseline and 24±2 weeks

Study Arms (1)

Patients with essential hypertension

Drug: Telmisartan; Drug: amlodipine

Interventions

Telmisartan DRUG

Telmisartan 40mg or 80mg

Patients with essential hypertension

amlodipine DRUG

amlodipine 5mg or 10mg

Patients with essential hypertension

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Korean

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (55)

Boehringer Ingelheim Investigational Site 15

Busan, South Korea

Location

Boehringer Ingelheim Investigational Site 37

Busan, South Korea

Location

Boehringer Ingelheim Investigational Site 42

Busan, South Korea

Location

Boehringer Ingelheim Investigational Site 55

Busan, South Korea

Location

Boehringer Ingelheim Investigational Site 54

Chonbuk, South Korea

Location

Boehringer Ingelheim Investigational Site 18

Chonnam, South Korea

Location

Boehringer Ingelheim Investigational Site 48

Chungcheong, South Korea

Location

Boehringer Ingelheim Investigational Site 46

Daegu, South Korea

Location

Boehringer Ingelheim Investigational Site 31

Daejeon, South Korea

Location

Boehringer Ingelheim Investigational Site 39

Daejeon, South Korea

Location

Boehringer Ingelheim Investigational Site 40

Daejeon, South Korea

Location

Boehringer Ingelheim Investigational Site 41

Daejeon, South Korea

Location

Boehringer Ingelheim Investigational Site 45

Daejeon, South Korea

Location

Boehringer Ingelheim Investigational Site 14

Deagu, South Korea

Location

Boehringer Ingelheim Investigational Site 25

Deagu, South Korea

Location

Boehringer Ingelheim Investigational Site 26

Deagu, South Korea

Location

Boehringer Ingelheim Investigational Site 44

Gangwon, South Korea

Location

Boehringer Ingelheim Investigational Site 24

Gwangju, South Korea

Location

Boehringer Ingelheim Investigational Site 32

Gwangju, South Korea

Location

Boehringer Ingelheim Investigational Site 11

Gyeonggi-do, South Korea

Location

Boehringer Ingelheim Investigational Site 13

Gyeonggi-do, South Korea

Location

Boehringer Ingelheim Investigational Site 16

Gyeonggi-do, South Korea

Location

Boehringer Ingelheim Investigational Site 21

Gyeonggi-do, South Korea

Location

Boehringer Ingelheim Investigational Site 23

Gyeonggi-do, South Korea

Location

Boehringer Ingelheim Investigational Site 30

Gyeonggi-do, South Korea

Location

Boehringer Ingelheim Investigational Site 43

Gyeonggi-do, South Korea

Location

Boehringer Ingelheim Investigational Site 47

Gyeonggi-do, South Korea

Location

Boehringer Ingelheim Investigational Site 5

Gyeonggi-do, South Korea

Location

Boehringer Ingelheim Investigational Site 6

Gyeonggi-do, South Korea

Location

Boehringer Ingelheim Investigational Site 9

Gyeonggi-do, South Korea

Location

Boehringer Ingelheim Investigational Site 35

Gyeongnam, South Korea

Location

Boehringer Ingelheim Investigational Site 51

Jeju City, South Korea

Location

Boehringer Ingelheim Investigational Site 52

Jeju City, South Korea

Location

Boehringer Ingelheim Investigational Site 17

Jungnam, South Korea

Location

Boehringer Ingelheim Investigational Site 19

Jungnam, South Korea

Location

Boehringer Ingelheim Investigational Site 8

Jungnam, South Korea

Location

Boehringer Ingelheim Investigational Site 12

Seoul, South Korea

Location

Boehringer Ingelheim Investigational Site 1

Seoul, South Korea

Location

Boehringer Ingelheim Investigational Site 20

Seoul, South Korea

Location

Boehringer Ingelheim Investigational Site 22

Seoul, South Korea

Location

Boehringer Ingelheim Investigational Site 27

Seoul, South Korea

Location

Boehringer Ingelheim Investigational Site 28

Seoul, South Korea

Location

Boehringer Ingelheim Investigational Site 29

Seoul, South Korea

Location

Boehringer Ingelheim Investigational Site 2

Seoul, South Korea

Location

Boehringer Ingelheim Investigational Site 33

Seoul, South Korea

Location

Boehringer Ingelheim Investigational Site 34

Seoul, South Korea

Location

Boehringer Ingelheim Investigational Site 36

Seoul, South Korea

Location

Boehringer Ingelheim Investigational Site 38

Seoul, South Korea

Location

Boehringer Ingelheim Investigational Site 3

Seoul, South Korea

Location

Boehringer Ingelheim Investigational Site 49

Seoul, South Korea

Location

Boehringer Ingelheim Investigational Site 4

Seoul, South Korea

Location

Boehringer Ingelheim Investigational Site 50

Seoul, South Korea

Location

Boehringer Ingelheim Investigational Site 53

Seoul, South Korea

Location

Boehringer Ingelheim Investigational Site 7

Seoul, South Korea

Location

Boehringer Ingelheim Investigational Site 10

Ulan, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2011
• First Posted: March 16, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 21, 2015
• Results First Posted: July 27, 2015

Record last verified: 2015-09

Locations

KR (55)