Hypertension Clinical Trial
Official title:
A Post-marketing Surveillance to Assess Safety and Efficacy of Twotopsplus.
NCT number | NCT03655288 |
Other study ID # | ID-TTP-401 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 25, 2017 |
Est. completion date | November 2023 |
Post-marketing surveillance of Twotopsplus.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | November 2023 |
Est. primary completion date | May 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Inha University Hospital | Incheon |
Lead Sponsor | Collaborator |
---|---|
IlDong Pharmaceutical Co Ltd |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of adverse event after this drug administration in general medical practice. | 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. |
12weeks | |
Primary | Incidence of serious adverse event after this drug administration in general medical practice | 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. |
12weeks |
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