- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03648788
A Post-marketing Surveillance to Assess Safety and Efficacy of Rosuvatatin/Ezetimibe
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sujin Kim
- Phone Number: 82-2-526-3478
- Email: sujinkim@ildong.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
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
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. |
24 weeks
|
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. |
24 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID-DRT-401
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mixed Dyslipidemia
-
Addpharma Inc.Recruiting
-
University of GuadalajaraCompleted
-
AbbottCompletedMixed DyslipidemiaUnited States
-
Hanlim Pharm. Co., Ltd.RecruitingMixed DyslipidemiaKorea, Republic of
-
Arrowhead PharmaceuticalsCompletedMixed DyslipidemiaUnited States, Australia, Poland, New Zealand, Canada, Hungary
-
Provident Clinical ResearchReliant PharmaceuticalsCompleted
-
Arrowhead PharmaceuticalsActive, not recruitingMixed DyslipidemiaUnited States, Australia, Canada, New Zealand
-
Provident Clinical ResearchReliant PharmaceuticalsUnknown
-
Kowa Research Institute, Inc.CompletedMixed Dyslipidemia | Primary DyslipidemiaUnited States
-
Merck Sharp & Dohme LLCTerminatedHypercholesterolemia | Mixed Dyslipidemia
Clinical Trials on NA (Observation study)
-
IlDong Pharmaceutical Co LtdCompletedIdiopathic Pulmonary Fibrosis
-
Wageningen UniversityNexira; Roquette Freres; Netherlands: Ministry of Health, Welfare and Sports; B... and other collaboratorsCompletedIrritable Bowel Syndrome | Microbial Colonization | Dietary HabitsNetherlands
-
National Taiwan University HospitalNational Taiwan University Hospital Hsin-Chu Branch; National Taiwan University...RecruitingHeart Failure With Preserved Ejection Fraction | Amyloidosis CardiacTaiwan
-
Assistance Publique - Hôpitaux de ParisNational Conservatory of Arts and Crafts (Cnam) of ParisUnknownFatigue | Stress | Occupational Exposure to Blood | Healthcare-associated Related InfectionsFrance
-
Rennes University HospitalCompleted
-
University of Texas Southwestern Medical CenterNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Recruiting
-
Swalife BiotechNot yet recruitingSmoking | Blood Sugar; High | Blood Pressure, High | Weight, BirthIndia
-
Hospices Civils de LyonCompletedStudy of Practices of Surgeons on Surgical Management of Asymptomatic Hernias | Comparison With International RecommendationsFrance
-
Kyunghee University Medical CenterHangang Sacred Heart Hospital; Samsung Medical Center; Pusan National University... and other collaboratorsUnknown
-
Charite University, Berlin, GermanyRecruiting