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

NCT03648801 — Unknown, 600 participants, IlDong Pharmaceutical Co Ltd

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RegistryNCT03648801
StatusUnknown
Study typeObservational
Enrollment600 (Estimated)
SponsorIlDong Pharmaceutical Co Ltd (Industry)
ConditionsHypertension, Dyslipidemia
Datesstart 2018-09-01 (estimated), primary completion 2024-05-01 (estimated), completion 2024-08-01 (estimated), first posted 2018-08-27, last updated 2018-08-31

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-Summary

Post-marketing surveillance of Telostop Plus Tab.

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+Detailed description

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

+Arms and interventions

ArmTypeInterventionsDescription
Hypertention, DyslipidemiaNA (Observation study)

+Outcome measures

Primary outcomes

  • 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.

+Eligibility

Sex: 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

My Notes