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A Regulatory Requirement Post-Marketing Surveillance Study to Monitor the Safety and Efficacy of Twynsta (Telmisartan + Amlodipine SPC, q.d.) in Korean Hypertensive Patients Requiring Combination Therapy

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:
NCT01243268
First received: November 17, 2010
Last updated: May 29, 2013
Last verified: May 2013
History of Changes
  Purpose

This is a prospective, observational, open-label, multi-center study, which will provide detailed information about the safety and efficacy of Twynsta tablets in Korean hypertensive patients requiring combination therapy. This will present a convenient treatment option for hypertension in Korean patients.


Condition Intervention
Hypertension
 Drug: Twynsta tablet

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Regulatory Requirement Post-Marketing Surveillance Study to Monitor the Safety and Efficacy of Twynsta (Telmisartan + Amlodipine SPC, q.d.) in Korean Hypertensive Patients Requiring Combination Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Safety endpoint All adverse events in patients who take at least one dose of Twynsta tablets will be noted [ Time Frame: 8+/-2weeks ] [ Designated as safety issue: No ]
  • Safety endpoint All adverse events in patients who take at least one does of Twynsta tablets will be noted [ Time Frame: 16+/-2weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy endpoint Percentage of patients achieving normal blood pressure (SBP/DBP < 140/90mmHg) [ Time Frame: 8+/-2weeks ] [ Designated as safety issue: No ]
  • Efficacy endpoint Percentage of patients achieving normal blood pressure (SBP/DBP < 140/90mmHg) [ Time Frame: 16+/-2weeks ] [ Designated as safety issue: No ]
  • Efficacy endpoint Percentage of patients achieving DBP response (defined as mean seated DBP < 90mmHg or a drop of more than 10mmHg) [ Time Frame: 8+/-2weeks ] [ Designated as safety issue: No ]
  • Efficacy endpoint Percentage of patients achieving DBP response (defined as mean seated DBP < 90mmHg or a drop of more than 10mmHg) [ Time Frame: 16+/-2weeks ] [ Designated as safety issue: No ]
  • Efficacy endpoint Percentage of patients achieving SBP response (defined as mean seated SBP < 140mmHg or a drop of more than 10mmHg) [ Time Frame: 8+/-2weeks ] [ Designated as safety issue: No ]
  • Efficacy endpoint Percentage of patients achieving SBP response (defined as mean seated SBP < 140mmHg or a drop of more than 10mmHg) [ Time Frame: 16+/-2weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: December 2010
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with essential hypertension Drug: Twynsta tablet
Telmisartan and Amlodipine T40/A5, T80/A5 and T40/A10

Detailed Description:

Study Design:

PMS Observational study

  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 patients wtih essential hypertension

Criteria

Inclusion criteria:

No specific inclusion and exclusion criteria will be provided due to the exploratory character of the study. Patients who have initiated Twynsta tablets according to the recommended and approved usage in Korea will be consecutively enrolled.

Exclusion criteria:

No specific inclusion and exclusion criteria will be provided due to the exploratory character of the study. Patients who have initiated Twynsta tablets according to the recommended and approved usage in Korea will be consecutively enrolled.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243268

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

Locations
Korea, Republic of
Boehringer Ingelheim Investigational Site 1 Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 33 Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 6 Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 23 Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 36 Recruiting
Choongnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 32 Recruiting
Choongnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 39 Recruiting
Choongnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 40 Recruiting
Chungnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 3 Recruiting
Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 7 Recruiting
Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 22 Recruiting
Daejun, Korea, Republic of
Boehringer Ingelheim Investigational Site 10 Recruiting
Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 9 Recruiting
Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 12 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 25 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 30 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 13 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 19 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 26 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 15 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 37 Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 4 Recruiting
Gyeonggi do, Korea, Republic of
Boehringer Ingelheim Investigational Site 34 Recruiting
Gyeongpook, Korea, Republic of
Boehringer Ingelheim Investigational Site 28 Recruiting
Incheon, Korea, Republic of
Boehringer Ingelheim Investigational Site 5 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 16 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 27 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 17 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 29 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 18 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 21 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 11 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 20 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 8 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 35 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 2 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 14 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 38 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 24 Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 31 Recruiting
Seoul, 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: NCT01243268     History of Changes
Other Study ID Numbers: 1235.40
Study First Received: November 17, 2010
Last Updated: May 29, 2013
Health Authority: South Korea: Ministry of Food and Drug Safety (MFDS)

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Telmisartan
Benzoates
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
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on June 18, 2013