Post Marketing Surveillance of Telostop TAB (Telmisartan/Rosuvastatin) for Evaluating the Safety and Efficacy

IlDong Pharmaceutical Co Ltd600 enrolled

Overview

Post-marketing surveillance of Telostop TAB (Telmisartan/Rosuvastatin)

Telostop TAB is fixed-dose combination of telmisartan and rosuvastatin, which was approved in 2015 in the Republic of Korea for the treatment of patients with hypertention and dyslipidemia. A post-marketing surveillance was conducted following the approval to obtain data on the safety and efficacy of Telostop TAB in real-world practice.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Hypertension Dyslipidemias

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patient who is first prescribed and administered Telostop plus Tab. Exclusion Criteria: * The patients who are overreacting to this drug or its components * The patients to the "Do not administer to the next patient" section of the approved instructions for use

Outcomes

Primary Outcomes

Incidence of adverse event after this drug administration in general medical practice

Any adverse events occurred after this drug dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events.

Time frame: 24 weeks

Secondary Outcomes

The change from baseline to week 24 in the LDL cholesterol

LDL cholesterol is measured before administration of the drug and within 24 weeks after administration.

Time frame: 24 weeks

The change from baseline to week 24 in the blood pressure

Blood pressure is measured before administration of the drug and within 24 weeks after administration.

Time frame: 24 weeks

Data from ClinicalTrials.gov

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