A Post-marketing Surveillance to Assess Safety and Efficacy of Twotopsplus.

• Conditions: Hypertension

• Registration Number: NCT03655288
• Lead Sponsor: IlDong Pharmaceutical Co Ltd

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 Timeline

• Study Start: 2017-07-25
• Status Verified: 2018-08
• Study First Submitted: 2018-08-29
• Study First Submitted QC: 2018-08-29
• Last Update Submitted: 2018-08-30
• Study First Posted: 2018-08-31
• Last Update Posted: 2018-09-04
• Primary Completion: 2023-05
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of