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

NCT ID: NCT01243268

Last Updated: 2018-10-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

674 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-21

Study Completion Date

2016-08-18

Brief Summary

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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.

Detailed Description

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Study Design:

PMS Observational study

Conditions

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Hypertension

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with essential hypertension

Twynsta tablet

Intervention Type DRUG

Telmisartan and Amlodipine T40/A5, T80/A5 and T40/A10

Interventions

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Twynsta tablet

Telmisartan and Amlodipine T40/A5, T80/A5 and T40/A10

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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NISND Center

One Or Multiple Sites, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1235.40

Identifier Type: -

Identifier Source: org_study_id

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