A Post-marketing Surveillance to Assess Safety and Efficacy of Telostop Plus Tab.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03648801

Enrollment

600

Registered

2018-08-27

Start date

2018-09-30

Completion date

2024-08-31

Last updated

2018-08-31

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

Conditions

Hypertension, Dyslipidemia

Brief summary

Post-marketing surveillance of Telostop Plus Tab.

Detailed description

This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of MFDS for market authorization.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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 with severe renal impairment

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.
Incidence of serious adverse event after this drug administration in general medical practice	24 weeks	Any serious adverse events occurred after this drug dosing will be recorded. Description of serious adverse event(s) including type of serious adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the serious 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 serious adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be serious adverse events.

Outcome results