Exploratory Study of the Effect of Omega-3-acid Ethyl Est... | NCT02824432

ID	Type	Description	Link
U1111-1182-6745	Other Identifier	WHO
JapicCTI-163269	Registry Identifier	JapicCTI

Label	Type	Description	Intervention Names
TAK-085 2g	Experimental	A dose of 2 grams of omega-3-acid ethyl esters (TAK-085) will be orally administered once a day immediately after meal.	Drug: TAK-085
TAK-085 4g	Experimental	A dose of 4 grams of omega-3-acid ethyl esters (TAK-085) will be orally administered twice a day immediately after meal.	Drug: TAK-085

Name	Type	Description	Arm Group Labels	Other Names
TAK-085	Drug	TAK-085 capsules	TAK-085 2g TAK-085 4g

Measure	Description	Time Frame
Flow-mediated Dilation (FMD) With Fasting State at Baseline, Week 4 and Week 8	FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.	Prior to meal at Baseline, Week 4, and Week 8
Change From Baseline in FMD With Fasting State at Week 4 and Week 8	FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.	Prior to meal at Baseline and Week 4, and Week 8
Percent Change From Baseline in FMD With Fasting State at Baseline, Week 4 and Week 8	FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.	Prior to meal at Baseline and Week 4, and Week 8

Measure	Description	Time Frame
FMD With 4-Hours Postprandial State at Baseline and Week 8	FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.

Name	Affiliation	Role
Study Director	Takeda	Study Director

PubMed Identifier	Type	Citation	Retractions
32200533	Derived	Teramoto T, Shibata H, Suzaki Y, Matsui S, Uemura N, Tomiyama H, Yamashina A. Discrepancy Between Fasting Flow-Mediated Dilation and Parameter of Lipids in Blood: A Randomized Exploratory Study of the Effect of Omega-3 Fatty Acid Ethyl Esters on Vascular Endothelial Function in Patients With Hyperlipidemia. Adv Ther. 2020 May;37(5):2169-2183. doi: 10.1007/s12325-020-01286-1. Epub 2020 Mar 21.

ID	Title	Description
FG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
FG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 7, 2016	Aug 10, 2018

Primary

Flow-mediated Dilation (FMD) With Fasting State at Baseline, Week 4 and Week 8

FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

Percentage of dilation

Prior to meal at Baseline, Week 4, and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants	OG00018 OG00119

Title

Denominators

Categories

Baseline

- ParticipantsOG00017
- ParticipantsOG00117

Title	Measurements
	OG0006.71± 3.466

Primary

Change From Baseline in FMD With Fasting State at Week 4 and Week 8

FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

Percentage of dilation

Prior to meal at Baseline and Week 4, and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants

Primary

Percent Change From Baseline in FMD With Fasting State at Baseline, Week 4 and Week 8

FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

Percent of Change

Prior to meal at Baseline and Week 4, and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants

Secondary

FMD With 4-Hours Postprandial State at Baseline and Week 8

FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

Percentage of dilation

4-hours after meal at Baseline and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants

Secondary

Change From Baseline in FMD With 4-Hours Postprandial State at Week 8

FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

Percentage of dilation

4-hours after meal at Baseline and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants

Secondary

Percent Change From Baseline in FMD With 4-Hours Postprandial State at Week 8

FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

Percent of Change

4-hours after meal at Baseline and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants

Secondary

Triglyceride (TG) Level With Fasting State at Baseline, Week 4, and Week 8

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

mg/dL

Prior to meal at Baseline, Week 4, and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in TG Level With Fasting State at Week 4 and Week 8

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

mg/dL

Prior to meal at Baseline and Week 4, and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in TG Level With Fasting State at Week 4 and Week 8

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

Percent of Change

Prior to meal at Baseline and Week 4, and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants	OG000

Secondary

TG Level With 4-Hours Postprandial State at Baseline, Week 4 and Week 8

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

mg/dL

4-hours after meal at Baseline, Week 4, and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

mg/dL

4-hours after meal at Baseline and Week 4, and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

Percent of Change

4-hours after meal at Baseline and Week 4, and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants	OG000

Secondary

Dihomo-gamma-linolenic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

microgram (μg)/milliliter (mL)

Prior to meal at Baseline, Week 4 and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants

Secondary

Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Dihomo-gamma-linolenic acid at each time point.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

μg/mL

Prior to meal at Baseline and Week 4, and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants

Secondary

Percent Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Dihomo-gamma-linolenic acid at each time point.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

Percent of Change

Prior to meal at Baseline and Week 4, and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants

Secondary

Arachidonic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

μg/mL

Prior to meal at Baseline, Week 4 and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants

Secondary

Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Arachidonic acid at each time point.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

μg/mL

Prior to meal at Baseline and Week 4, and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants

Secondary

Percent Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Arachidonic acid at each time point.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

Percent of Change

Prior to meal at Baseline and Week 4, and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants

Secondary

Eicosapentaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

μg/mL

Prior to meal at Baseline, Week 4 and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants

Secondary

Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Eicosapentaenoic acid at each time point.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

μg/mL

Prior to meal at Baseline and Week 4, and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants

Secondary

Percent Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Eicosapentaenoic acid at each time point.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

Percent of Change

Prior to meal at Baseline and Week 4, and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants

Secondary

Docosahexaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

μg/mL

Prior to meal at Baseline, Week 4 and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants

Secondary

Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Docosahexaenoic acid at each time point.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

μg/mL

Prior to meal at Baseline and Week 4, and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants

Secondary

Percent Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Docosahexaenoic acid at each time point.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

Percent of Change

Prior to meal at Baseline and Week 4, and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants

Secondary

Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

Ratio

Prior to meal at Baseline, Week 4 and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants

Secondary

Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in EPA/AA Ratio at each time point.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

Ratio

Prior to meal at Baseline and Week 4, and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants

Secondary

Percent Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in EPA/AA Ratio at each time point.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

Percent of Change

Prior to meal at Baseline and Week 4, and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants

Secondary

Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

Ratio

Prior to meal at Baseline, Week 4 and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants

Secondary

Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in DHA/AA ratio at each time point.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

Ratio

Prior to meal at Baseline and Week 4, and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants

Secondary

Percent Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in DHA/AA ratio at each time point.

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Mean

Standard Deviation

Percent of Change

Prior to meal at Baseline and Week 4, and Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants

Secondary

Number of Participants Reporting One or More Adverse Events (AEs)

Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.

Posted

Count of Participants

Participants

Up to Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants	OG000

Secondary

Number of Participants Reporting One or More AEs Related to Body Weight

Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.

Posted

Count of Participants

Participants

Up to Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants	OG000

Secondary

Number of Participants Reporting One or More AEs Related to Blood Pressure in the Sitting Position

Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.

Posted

Count of Participants

Participants

Up to Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants	OG000

Secondary

Number of Participants Reporting One or More AEs Related to Pulse in the Sitting Position

Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.

Posted

Count of Participants

Participants

Up to Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants	OG000

Secondary

Number of Participants Reporting One or More AEs Related to Laboratory Tests of Fasting Plasma Glucose

Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.

Posted

Count of Participants

Participants

Up to Week 8

ID	Title	Description
OG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
OG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.

Units	Counts
Participants	OG000

Facility	Status	City	State	ZIP	Country	Contacts
		Yufu	Oita Prefecture		Japan

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk
Diarrhoea	Gastrointestinal disorders	20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk
Vomiting	Gastrointestinal disorders	20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk
Pharyngitis	Infections and infestations	20.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk
Upper respiratory tract infection	Infections and infestations	20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk
Viral upper respiratory tract infection	Infections and infestations	20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	20.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk

ID	Term
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Title	Description
BG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.
BG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	TAK-085 2 g	A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	0	18	0	18	4	18
EG001	TAK-085 4 g	A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.	0	19	0	19	2	19