Mixed DyslipidemiaNCT03648788
A Post-marketing Surveillance to Assess Safety and Efficacy of Rosuvatatin/Ezetimibe
An observational study of Mixed Dyslipidemia, run by IlDong Pharmaceutical Co Ltd.
Trial summary
Post-marketing surveillance of Rosuvastatin/Ezetimibe Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mixed Dyslipidemia
- What is being tested?
- NA (Observation study)
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patient diagnosed with mixed dyslipidemia
Who may be able to join
- The patient who is first prescribed and administered Rosuvastatin/Ezetimibe
Who cannot join
- The patients who are overreacting to this drug or its components
- The patients with severe renal impairment
Trial locations and contacts
No sites are listed yet.
About this study
Post-marketing surveillance of Rosuvastatin/Ezetimibe
Read the detailed description
This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of MFDS for market authorization.
- Conditions
- Mixed Dyslipidemia
- Being tested
- NA (Observation study)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NA (Observation study)Other
NA (Observation study)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study startSep 2018 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648788
- Sponsor's protocol ID
- ID-DRT-401
- Status last verified
- Aug 2018
- First submitted
- 14 Aug 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-marketing Surveillance to Assess Safety and Efficacy of Rosuvatatin/Ezetimibe
- ClinicalTrials.gov ID
- NCT03648788
- Acronym / sponsor ID
- ID-DRT-401
- Conditions
- Mixed Dyslipidemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2018 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-marketing surveillance of Rosuvastatin/Ezetimibe
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patient diagnosed with mixed dyslipidemia
Key inclusion criteria (1 listed)
- The patient who is first prescribed and administered Rosuvastatin/Ezetimibe
Key exclusion criteria (2 listed)
- The patients who are overreacting to this drug or its components
- The patients with severe renal impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NA (Observation study)NA (Observation study) | Other | – |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Mixed Dyslipidemia, run by IlDong Pharmaceutical Co Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sujin Kim (82-2-526-3478, sujinkim@ildong.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse event after this drug administration in general medical practice (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.