A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorBoryung Pharmaceutical Co., Ltd
About this trial
The purpose of this study is to evaluate the efficacy and safety of fixed-Dose combination of Pitavastatin/Ezetimibe under the real-world condition
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Those who taking statins or statins and ezetimibe in addition to dietary and exercise therapy for primary hypercholesterolemia or mixed hyperlipidemia
Those who are judged to need administration of a fixed-dose combination of pitavastatin/ezetimibe for change of statin's formulation or change of statin's dose, addition of ezetimibe
Disqualifiers
Those who are taking a fixed-dose combination of pitavastatin/ezetimibe at study enrollment
Those with hypersensitivity reactions or relevant medical history to pitavastatin or ezetimibe
Those who have been administered an investigational product within 12 weeks of the enrollment date or are planning to participate in another clinical trial during this study participation period.
Trial population
Patients who require administration of a fixed-dose combination of pitavastatin/ezetimibe for the treatment of primary hypercholesterolemia or mixed dyslipidemia
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Rate of reaching the target LDL Cholesterol level
Time frame
12 weeks after administrationSponsors and contacts
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Source ClinicalTrials.gov