Trials / Completed
CompletedNCT02285166
Specified Drug-use Survey of the Granular Capsule Formulation of Omega-3 Fatty Acid Ethyl Esters: OCEAN3
Specified Drug-use Survey of Lotriga Granular Capsules: OCEAN3 (Outcome Prevention on Cardiovascular Events by Antihyperlipidemic Therapy With N3-fatty Acid in Japan)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 15,330 (actual)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this survey is to determine the incidence rate of cardiovascular (CV) events associated with long-term treatment with and without omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) in high-risk hyperlipidemic patients treated by statin in daily medical practice.
Detailed description
This survey is planned to determine the incidence rate of cardiovascular (CV) events associated with long-term treatment with omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) in high-risk hyperlipidemic patients treated by statin in daily medical practice. The incidence rate of CV events in the participants who are treated by the standard anti-hyperlipidemic therapies other than omega-3 fatty acid ethyl esters is investigated in this survey so as to compare the events rates between two participant groups just for information. For adults, 2 g of omega-3 fatty acid ethyl esters is usually administered orally once daily immediately after meals. However, the dose can be increased up to twice daily (to a dose of 2 g) depending on participant's triglyceride (TG) level.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Omega-3 fatty acid ethyl esters | Omega-3 fatty acid ethyl esters granular capsules |
| DRUG | Standard antihyperlipidemic therapy other than administration of omega-3 fatty acid ethyl esters (Lotriga). |
Timeline
- Start date
- 2014-10-21
- Primary completion
- 2020-07-14
- Completion
- 2020-07-14
- First posted
- 2014-11-06
- Last updated
- 2022-02-18
- Results posted
- 2022-02-18
Locations
2 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02285166. Inclusion in this directory is not an endorsement.