Post Marketing Surveillance of Telostop TAB (Telmisartan/Rosuvastatin) for Evaluating the Safety and Efficacy

Hypertension Clinical Trial

Official title:

Post Marketing Surveillance of Telostop TAB (Telmisartan/Rosuvastatin) for Evaluating the Safety and Efficacy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03742544
• Other study ID #: ID-TERO-401
• Status: Enrolling by invitation
• 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
• 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

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension

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