Trial · NCT01350973

Efficacy of TAK-085 in Participants With Hypertriglyceridemia

NCT01350973, Phase 3, Completed, Takeda; results first posted 2016-09-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy of TAK-085 in Participants With Hypertriglyceridemia. Trials, record NCT01350973. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01350973

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy of TAK-085 in Participants With Hypertriglyceridemia
NCT number: NCT01350973
Status: Completed
Phases: Phase 3
Enrollment: 611 participants, actual
Lead sponsor: Takeda
Conditions: Hypertriglyceridemia
Interventions: Omega-3-acid ethyl esters 90 (TAK-085), Eicosapentaenoic acid-ethyl (EPA-E)
First posted: 2011-05-10
Last updated: 2016-09-20
Results first posted: 2016-09-20

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Change From Baseline in Triglyceride Level at the Final Visit	Baseline and 12 weeks	The percentage change between triglycerides collected at the end of study drug administration (the end of treatment period or discontinuation) relative to Baseline. Analysis of Covariance (ANCOVA) model was employed, using the Baseline triglyceride level as covariate and the treatment group as an independent variable.
Secondary	Percent Change From Baseline in Triglyceride Level Over Time	Baseline and Weeks 4, 8, 10 and 12	The percentage change between triglycerides collected at each study visit relative to Baseline.
Secondary	Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time	Baseline and Weeks 4, 8, 10 and 12	The percentage change between low-density lipoprotein cholesterol collected at each study visit relative to Baseline. Low-density lipoprotein cholesterol particles measured directly by nuclear magnetic resonance.
Secondary	Percent Change From Baseline in Total Cholesterol Over Time	Baseline and Weeks 4, 8, 10 and 12	The percentage change between total cholesterol measured at each study visit relative to Baseline.
Secondary	Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time	Baseline and Weeks 4, 8, 10 and 12	The percentage change between high-density lipoprotein cholesterol collected at each study visit relative to Baseline.
Secondary	Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time	Baseline and Weeks 4, 8, 10 and 12	The percentage change between non-high-density lipoprotein cholesterol collected at each study visit relative to Baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	12 Weeks
Secondary	Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs	12 Weeks
Secondary	Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis	12 Weeks
Secondary	Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings After Study Drug Administration	12 Weeks

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change From Baseline in Triglyceride Level at the Final Visit	Baseline and 12 weeks	Full analysis set including all participants who were randomized and received at least one dose of the investigational product and with available data.	percent change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change From Baseline in Triglyceride Level Over Time	Baseline and Weeks 4, 8, 10 and 12	Full analysis set with available data at each time point (indicated by n).	percent change	MEAN
SECONDARY	Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time	Baseline and Weeks 4, 8, 10 and 12	Full analysis set with available data at each time point (indicated by n).	percent change	MEAN
SECONDARY	Percent Change From Baseline in Total Cholesterol Over Time	Baseline and Weeks 4, 8, 10 and 12	Full analysis set with available data at each time point (indicated by n).	percent change	MEAN
SECONDARY	Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time	Baseline and Weeks 4, 8, 10 and 12	Full analysis set with available data at each time point (indicated by n).	percent change	MEAN
SECONDARY	Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time	Baseline and Weeks 4, 8, 10 and 12	Full analysis set with available data at each time point (indicated by n).	percent change	MEAN
SECONDARY	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	12 Weeks	Safety Analysis Set included all participants who received at least one dose of the investigational product.	participants	NUMBER
SECONDARY	Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs	12 Weeks	Safety Analysis Set included all participants who received at least one dose of the investigational product.	participants	NUMBER
SECONDARY	Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis	12 Weeks	Safety Analysis Set included all participants who received at least one dose of the investigational product.	participants	NUMBER
SECONDARY	Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings After Study Drug Administration	12 Weeks	Safety Analysis Set included all participants who received at least one dose of the investigational product.	participants	NUMBER

Source ClinicalTrials.gov

Results by group75

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percent Change From Baseline in Triglyceride Level at the Final Visit	TAK-085 2 g		-10.93	Standard Error 1.6434	percent change
Percent Change From Baseline in Triglyceride Level at the Final Visit	TAK-085 4 g		-22.65	Standard Error 1.6238	percent change
Percent Change From Baseline in Triglyceride Level at the Final Visit	EPA-E 1.8 g		-11.30	Standard Error 1.6807	percent change
Percent Change From Baseline in Triglyceride Level Over Time	TAK-085 2 g	Week 4 (n=203, 208, 192)	-13.085	Standard Deviation 26.4479	percent change
Percent Change From Baseline in Triglyceride Level Over Time	TAK-085 4 g	Week 4 (n=203, 208, 192)	-26.939	Standard Deviation 20.9540	percent change
Percent Change From Baseline in Triglyceride Level Over Time	EPA-E 1.8 g	Week 4 (n=203, 208, 192)	-11.417	Standard Deviation 27.8599	percent change
Percent Change From Baseline in Triglyceride Level Over Time	TAK-085 2 g	Week 8 (n=199, 205, 191)	-12.055	Standard Deviation 23.5955	percent change
Percent Change From Baseline in Triglyceride Level Over Time	TAK-085 4 g	Week 8 (n=199, 205, 191)	-22.501	Standard Deviation 29.7039	percent change
Percent Change From Baseline in Triglyceride Level Over Time	EPA-E 1.8 g	Week 8 (n=199, 205, 191)	-11.321	Standard Deviation 29.6792	percent change
Percent Change From Baseline in Triglyceride Level Over Time	TAK-085 2 g	Week 10 (n=198, 202, 188)	-9.707	Standard Deviation 25.9148	percent change

1 to 10 of 75Source ClinicalTrials.gov

See all 75 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	TAK-085 2 g	206
Overall Study	STARTED	TAK-085 4 g	210
Overall Study	STARTED	EPA-E 1.8 g	195
Overall Study	Received Treatment	TAK-085 2 g	205
Overall Study	Received Treatment	TAK-085 4 g	210
Overall Study	Received Treatment	EPA-E 1.8 g	195
Overall Study	COMPLETED	TAK-085 2 g	200
Overall Study	COMPLETED	TAK-085 4 g	202
Overall Study	COMPLETED	EPA-E 1.8 g	187
Overall Study	NOT COMPLETED	TAK-085 2 g	6

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events27

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nasopharyngitis	Infections and infestations	TAK-085 2 g	22	205
other	Nasopharyngitis	Infections and infestations	TAK-085 4 g	9	210
other	Nasopharyngitis	Infections and infestations	EPA-E 1.8 g	20	195
serious	Myelofibrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	TAK-085 2 g	1	205
serious	Myelofibrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	TAK-085 4 g	0	210
serious	Myelofibrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EPA-E 1.8 g	0	195
serious	Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	TAK-085 2 g	0	205
serious	Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	TAK-085 4 g	1	210
serious	Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EPA-E 1.8 g	0	195
serious	Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	TAK-085 2 g	0	205

1 to 10 of 27Source ClinicalTrials.gov

See all 27 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	TAK-085 2 g
Total, all-cause mortality	TAK-085 4 g
Total, all-cause mortality	EPA-E 1.8 g
Total, other adverse events	TAK-085 2 g	22	205
Total, other adverse events	TAK-085 4 g	9	210
Total, other adverse events	EPA-E 1.8 g	20	195
Total, serious adverse events	TAK-085 2 g	1	205
Total, serious adverse events	TAK-085 4 g	4	210
Total, serious adverse events	EPA-E 1.8 g	2	195

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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