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

Boehringer Ingelheim674 enrolled

Overview

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 Design: PMS Observational study

Study Type

OBSERVATIONAL

Enrollment

674

Conditions

Hypertension

Interventions

Twynsta tabletDRUG

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

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (1)

NISND Center

One Or Multiple Sites, South Korea

Outcomes

Primary Outcomes

Percentage of Subjects With Adverse Events

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)

Time frame: Short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks)

Secondary Outcomes

Percentage of Subjects Who Had Achieved Normal Blood Pressure (Systolic Blood Pressure (SBP)/ Diastolic Blood Pressure (DBP) < 140/90 mmHg)

Percentage of subjects who had achieved normal blood pressure (SBP/DBP \< 140/90 millimeters of mercury (mmHg))is presented

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)

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

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)

Percentage of subjects who achieved SBP response (defined as mean sitting SBP \< 140 mmHg or a reduction of over 10 mmHg) is presented

Time frame: 8±2 weeks

Percentage of Subjects With Diabetes or Renal Impairment Who Achieved SBP/DBP < 130/80 mmHg.

Percentage of subjects with diabetes or renal impairment who achieved SBP/DBP \< 130/80 mmHg is presented

Time frame: 8±2 weeks

Data from ClinicalTrials.gov

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