Evaluation of the Safety and Efficacy of Long-term Use of Lotriga
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|ClinicalTrials.gov Identifier: NCT02153073|
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : July 7, 2017
|Condition or disease||Intervention/treatment|
|Hyperlipidemia||Drug: Omega-3 fatty acid ethyl esters|
|Study Type :||Observational|
|Actual Enrollment :||3084 participants|
|Official Title:||Lotriga Granular Capsules Special Drug Use Surveillance (Long-term Use Survey)|
|Actual Study Start Date :||May 29, 2013|
|Actual Primary Completion Date :||May 31, 2017|
|Actual Study Completion Date :||May 31, 2017|
Omega-3 fatty acid ethyl esters 2 g
Omega-3 fatty acid ethyl esters 2 g, administered orally once or twice daily after meals
Drug: Omega-3 fatty acid ethyl esters
Omega-3 fatty acid ethyl esters granular capsules
Other Name: Lotriga Granular Capsules
- Frequency of adverse events [ Time Frame: 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.
- Changes from baseline in lipid parameters [ Time Frame: From Baseline and Month12 ]For lipid parameters such as triglycerides (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 valuesare tabulated at each observational point.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153073
|Study Chair:||Postmarketing Group Manager||Takeda|