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
December 14, 2017 updated by: Boehringer Ingelheim
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.
Study Overview
Detailed Description
Study Design:
PMS Observational study
Study Type
Observational
Enrollment (Actual)
674
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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One Or Multiple Sites, Korea, Republic of
- NISND Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Korean patients wtih essential hypertension
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with essential hypertension
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Telmisartan and Amlodipine T40/A5, T80/A5 and T40/A10
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Subjects With Adverse Events
Time Frame: Short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks)
|
Percentage of subjects with adverse events is presented.
Results are reported for short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks)
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Short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Subjects Who Had Achieved Normal Blood Pressure (Systolic Blood Pressure (SBP)/ Diastolic Blood Pressure (DBP) < 140/90 mmHg)
Time Frame: 8±2 weeks
|
Percentage of subjects who had achieved normal blood pressure (SBP/DBP < 140/90 millimeters of mercury (mmHg))is presented
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8±2 weeks
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Percentage of Subjects Who Achieved DBP Response (Defined as Mean Sitting DBP < 90 mmHg or a Reduction of Over 10 mmHg)
Time Frame: 8±2 weeks
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Percentage of subjects who achieved DBP response (defined as mean sitting DBP < 90 mmHg or a reduction of over 10 mmHg) is presented
|
8±2 weeks
|
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Percentage of Subjects Who Achieved SBP Response (Defined as Mean Sitting SBP < 140 mmHg or a Reduction of Over 10 mmHg)
Time Frame: 8±2 weeks
|
Percentage of subjects who achieved SBP response (defined as mean sitting SBP < 140 mmHg or a reduction of over 10 mmHg) is presented
|
8±2 weeks
|
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Percentage of Subjects With Diabetes or Renal Impairment Who Achieved SBP/DBP < 130/80 mmHg.
Time Frame: 8±2 weeks
|
Percentage of subjects with diabetes or renal impairment who achieved SBP/DBP < 130/80 mmHg is presented
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8±2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 21, 2010
Primary Completion (Actual)
June 27, 2016
Study Completion (Actual)
August 18, 2016
Study Registration Dates
First Submitted
November 17, 2010
First Submitted That Met QC Criteria
November 17, 2010
First Posted (Estimate)
November 18, 2010
Study Record Updates
Last Update Posted (Actual)
October 22, 2018
Last Update Submitted That Met QC Criteria
December 14, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1235.40
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.