A Post-marketing Surveillance to Assess Safety and Efficacy of Twotopsplus.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- IlDong Pharmaceutical Co Ltd
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Incidence of adverse event after this drug administration in general medical practice.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Incidence of adverse event after this drug administration in general medical practice.
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported