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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

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ClinicalTrials.gov Identifier: NCT01243268
Recruitment Status : Completed
First Posted : November 18, 2010
Results First Posted : October 22, 2018
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Hypertension Drug: Twynsta tablet

Detailed Description:

Study Design:

PMS Observational study

Study Design
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Study Type : Observational
Actual Enrollment : 674 participants
Observational Model: Other
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
Actual Study Start Date : December 21, 2010
Actual Primary Completion Date : June 27, 2016
Actual Study Completion Date : August 18, 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with essential hypertension Drug: Twynsta tablet
Telmisartan and Amlodipine T40/A5, T80/A5 and T40/A10


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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 ]
    Percentage of subjects who achieved DBP response (defined as mean sitting DBP < 90 mmHg or a reduction of over 10 mmHg) is presented

  3. 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

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243268


Locations
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Korea, Republic of
NISND Center
One Or Multiple Sites, Korea, Republic of
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01243268    
Other Study ID Numbers: 1235.40
First Posted: November 18, 2010    Key Record Dates
Results First Posted: October 22, 2018
Last Update Posted: October 22, 2018
Last Verified: December 2017
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan amlodipine combination
 Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action