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

NCT03742544 | Unknown

• 1 other identifier: ID-TERO-401
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hypertension; Dyslipidemias

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The change from baseline to week 24 in the LDL cholesterol

  24 weeks

• The change from baseline to week 24 in the blood pressure

  24 weeks

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

residents of Korea, in real-world practice

You may qualify if:

• The patient who is first prescribed and administered Telostop plus Tab.

You may not qualify if:

• 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

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead

MeSH Terms

Conditions

Hypertension; Dyslipidemias

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 15, 2018
• Study Start: June 23, 2015
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: November 15, 2018

Record last verified: 2018-11