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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03742544

Enrollment

600

Registered

2018-11-15

Start date

2015-06-23

Completion date

2020-10-30

Last updated

2018-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemias, Hypertension

Brief summary

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

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of adverse event after this drug administration in general medical practice	24 weeks	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.

Secondary

Measure	Time frame	Description
The change from baseline to week 24 in the LDL cholesterol	24 weeks	LDL cholesterol is measured before administration of the drug and within 24 weeks after administration.
The change from baseline to week 24 in the blood pressure	24 weeks	Blood pressure is measured before administration of the drug and within 24 weeks after administration.

Outcome results