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Completed

NCT Number: NCT01243268

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 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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NISND Center

One Or Multiple Sites, South Korea

About this study

Study Design:

PMS Observational study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Twynsta tablet

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Nov 18, 2010
Registry last updated
Oct 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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