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

• Conditions: Hypertension; Dyslipidemias

• Registration Number: NCT03742544
• Lead Sponsor: IlDong Pharmaceutical Co Ltd

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2015-06-23
• Status Verified: 2018-11
• Study First Submitted: 2018-11-12
• Study First Submitted QC: 2018-11-14
• Last Update Submitted: 2018-11-14
• Study First Posted: 2018-11-15
• Last Update Posted: 2018-11-15
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30

Recruitment & Eligibility

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

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

• 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	24 weeks	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.

Secondary Outcome Measures

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