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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03742544
Recruitment Status : Enrolling by invitation
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
IlDong Pharmaceutical Co Ltd

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

Condition or disease
Hypertension Dyslipidemias

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.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance of Telostop TAB (Telmisartan/Rosuvastatin) for Evaluating the Safety and Efficacy
Actual Study Start Date : June 23, 2015
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Incidence of adverse event after this drug administration in general medical practice [ Time Frame: 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 :
  1. The change from baseline to week 24 in the LDL cholesterol [ Time Frame: 24 weeks ]
    LDL cholesterol is measured before administration of the drug and within 24 weeks after administration.

  2. The change from baseline to week 24 in the blood pressure [ Time Frame: 24 weeks ]
    Blood pressure is measured before administration of the drug and within 24 weeks after administration.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
residents of Korea, in real-world practice
Criteria

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
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Responsible Party: IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT03742544    
Other Study ID Numbers: ID-TERO-401
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases