Hyperlipidemia
Conditions
Interventions
investigational material(s)
Generic name etc : Lotriga Granular Capsules (omega-3 fatty acid ethyl esters)
INN of investigational material :
Therapeutic category code : 218 Agents for hyperlipidemias
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with hyperlipidemia
Exclusion criteria
Exclusion criteria: (1) Patients with hemorrhage (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage) (2) Patients with a history of hypersensitivity to ingredients in Lotriga Granular Capsules
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events Primary timeframeFor 12 months The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in lipid parameters Secondary timeframeBaseline and month 12 For lipid parameters such as triglyceride (TG), total cholesterol (TC), LDL cholesterol (LDL-C), HDL cholesterol (HDL-C), non-HDL-C, observed values (or converted values) and percent changes (%) from baseline in these values are tabulated at each observational point. | — |
Outcome results
None listed