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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03742544
Other study ID # ID-TERO-401
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 23, 2015
Est. completion date October 30, 2020

Study information

Verified date November 2018
Source IlDong Pharmaceutical Co Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Post-marketing surveillance of Telostop TAB (Telmisartan/Rosuvastatin)


Description:

Telostop TAB is fixed-dose combination of telmisartan and rosuvastatin, which was approved in 2015 in the Republic of Korea for the treatment of patients with hypertention and dyslipidemia. A post-marketing surveillance was conducted following the approval to obtain data on the safety and efficacy of Telostop TAB in real-world practice.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 600
Est. completion date October 30, 2020
Est. primary completion date October 30, 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 to the "Do not administer to the next patient" section of the approved instructions for use

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
IlDong Pharmaceutical Co Ltd

Outcome

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.
24 weeks
Secondary The change from baseline to week 24 in the LDL cholesterol LDL cholesterol is measured before administration of the drug and within 24 weeks after administration. 24 weeks
Secondary The change from baseline to week 24 in the blood pressure Blood pressure is measured before administration of the drug and within 24 weeks after administration. 24 weeks
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