Text Size

Twynsta Study With Lifestyle Modifications in Korean Patients With Hypertension

This study is currently recruiting participants.
Verified May 2013 by Boehringer Ingelheim Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01316419
First received: March 15, 2011
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Hypertension
 Drug: Telmisartan and 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoint is the mean blood pressure change systolic blood pressure/diastolic blood pressure(SBP/DBP) from baseline after 24±2 weeks of treatment or at the last observation in case of early withdrawal. [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The key secondary endpoints include the percentage of patients achieving target blood pressure SBP/DBP <140/90 mmHg. [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The key secondary endpoints include the percentage of patients achieving DBP response (defined as mean seated DBP < 90 mmHg or a drop of = 10 mmHg). [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The key secondary endpoints include the percentage of patients achieving SBP response (defined as mean seated SBP < 140 mmHg or a drop of = 10 mmHg). [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The key secondary endpoints include the change from baseline of quality of life assessment data measured by World Health Organization Quality of Life Assessment Instrument (WHOQOL-BREF) and EuroQol Visual Analogue Scale (EQ VAS). [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The other secondary endpoints include the mean blood lipid change (High Density Lipoprotein Cholesterol, Low Density Lipoprotein Cholesterol, Triglycerides, and Total Cholesterol). [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The other secondary endpoints include the percentage of patients achieving normal Body Mass Index (18.5 kg/m2 to 24.9 kg/m2). [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The other secondary endpoints include the percentage of patients who complied with each category of lifestyle modification recommendations. [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The other secondary endpoints include the percentage of patient achieving SBP/DBP < 130/80 mmHg among patients with diabetes or kidney disease. [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • Safety will be evaluated by the incidence and severity of reported adverse events. [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: March 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with essential hypertension Drug: Telmisartan and amlodipine
Telmisartan and amlodipine 40/5mg or 40/10mg or 80/5mg

Detailed Description:

Study Design:

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Korean

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01316419

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Hide Study Locations
Locations
Korea, Republic of
Boehringer Ingelheim Investigational Site 15 Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 37 Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 42 Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 55 Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 54 Recruiting
Chonbuk, Korea, Republic of
Boehringer Ingelheim Investigational Site 18 Recruiting
Chonnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 48 Recruiting
Chungcheong, Korea, Republic of
Boehringer Ingelheim Investigational Site 8 Recruiting
Chungnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 17 Recruiting
Chungnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 19 Recruiting
Chungnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 46 Recruiting
Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 39 Recruiting
Daejeon, Korea, Republic of
Boehringer Ingelheim Investigational Site 40 Recruiting
Daejeon, Korea, Republic of
Boehringer Ingelheim Investigational Site 45 Recruiting
Daejeon, Korea, Republic of
Boehringer Ingelheim Investigational Site 31 Recruiting
Daejeon, Korea, Republic of
Boehringer Ingelheim Investigational Site 41 Recruiting
Daejeon, Korea, Republic of
Boehringer Ingelheim Investigational Site 26 Recruiting
Deagu, Korea, Republic of
Boehringer Ingelheim Investigational Site 14 Recruiting
Deagu, Korea, Republic of
Boehringer Ingelheim Investigational Site 25 Recruiting
Deagu, Korea, Republic of
Boehringer Ingelheim Investigational Site 44 Recruiting
Gangwon, Korea, Republic of
Boehringer Ingelheim Investigational Site 24 Recruiting
Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 32 Recruiting
Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 21 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 6 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 23 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 13 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 11 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 9 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 43 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 16 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 30 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 47 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 5 Recruiting
Gyeonggi do, Korea, Republic of
Boehringer Ingelheim Investigational Site 35 Recruiting
Gyeongnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 52 Recruiting
Jeju, Korea, Republic of
Boehringer Ingelheim Investigational Site 51 Recruiting
Jeju, Korea, Republic of
Boehringer Ingelheim Investigational Site 1 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 29 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 2 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 12 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 53 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 7 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 38 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 20 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 3 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 22 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 33 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 34 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 49 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 50 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 4 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 36 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 27 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 28 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 10 Recruiting
Ulan, Korea, Republic of
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01316419     History of Changes
Other Study ID Numbers: 1235.42
Study First Received: March 15, 2011
Last Updated: May 2, 2013
Health Authority: South Korea: Ministry of Food and Drug Safety (MFDS)

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Telmisartan
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013