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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03648801
Recruitment Status : Not yet recruiting
First Posted : August 27, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
IlDong Pharmaceutical Co Ltd

Brief Summary:
Post-marketing surveillance of Telostop Plus Tab.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Post-marketing Surveillance to Assess Safety and Efficacy of Telostop Plus Tab.
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Group/Cohort
Hypertention, Dyslipidemia
NA (Observation study)



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.


  2. Incidence of serious adverse event after this drug administration in general medical practice [ Time Frame: 24 weeks ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The patient diagnosed with hypertention and dyslipidemia
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 with severe renal impairment
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Responsible Party: IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT03648801    
Other Study ID Numbers: ID-TAR-P401
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

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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