NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-142457

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedHyperlipidemia
Date of first enrollment29/5/2013
Target sample size3084
Countries of recruitment
Study typeOBSERVATIONAL
Intervention(s)Intervention name : Lotriga Granular Capsules (omega-3 fatty acid ethyl esters) Dosage And administration of the intervention : The usual adult dosage is 2 g of omega-3 fatty acid ethyl esters administered orally once daily after meals. However, the dosage can be increased up to twice daily (at a dose of 2 g) depending on the patient's triglyceride level. Control intervention name : null

Outcome(s)

Primary OutcomeAdverse events Primary timeframe For 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 OutcomeChanges from baseline in lipid parameters Secondary timeframe Baseline 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.

Key inclusion & exclusion criteria

Age minimum
Age maximum
GenderBOTH
Include criteriaPatients with hyperlipidemia
Exclude 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

Related Information

Contact

public contact
Name Takeda Pharmaceutical Company Limited Contact for Clinical Trial Information
Address https://www.takeda.co.jp/contact/form/jp/form/
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