Hypertension
Conditions
Brief summary
Post-marketing surveillance of Twotopsplus.
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
Sponsors
IlDong Pharmaceutical Co Ltd
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* The patient diagnosed with hypertension. * The patient who is first prescribed and administered Twotopsplus 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. | 12weeks | 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 | 12weeks | 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. |
Countries
South Korea
Contacts
Primary Contactilondg ildong
Outcome results
None listed