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A Post-marketing Surveillance to Assess Safety and Efficacy of Rosuvatatin/Ezetimibe

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: NCT03648788
Recruitment Status : Not yet recruiting
First Posted : August 27, 2018
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
IlDong Pharmaceutical Co Ltd

Brief Summary:
Post-marketing surveillance of Rosuvastatin/Ezetimibe

Condition or disease Intervention/treatment
Mixed Dyslipidemia Other: NA (Observation study)

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 Rosuvatatin/Ezetimibe
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Ezetimibe


Intervention Details:
  • Other: NA (Observation study)
    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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patient diagnosed with mixed dyslipidemia
Criteria

Inclusion Criteria:

  • The patient who is first prescribed and administered Rosuvastatin/Ezetimibe

Exclusion Criteria:

  • The patients who are overreacting to this drug or its components
  • The patients with severe renal impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648788


Contacts
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Contact: Sujin Kim 82-2-526-3478 sujinkim@ildong.com

Sponsors and Collaborators
IlDong Pharmaceutical Co Ltd

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Responsible Party: IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT03648788    
Other Study ID Numbers: ID-DRT-401
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: August 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
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents