A Post-marketing Surveillance to Assess Safety and Efficacy of Telostop Plus Tab.

Post-marketing surveillance of Telostop Plus Tab.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension, Dyslipidemia

Detailed Description

This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of MFDS for market authorization.

• Study Type: Observational
• Enrollment (Anticipated): 600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patient diagnosed with hypertention and dyslipidemia

Description

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 with severe renal impairment

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Hypertention, Dyslipidemia; NA (Observation study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	24 weeks

Collaborators and Investigators

• Sponsor: IlDong Pharmaceutical Co Ltd

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 27, 2018

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: ID-TAR-P401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No