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Efficacy of TAK-085 in Participants With Hypertriglyceridemia

Primary Purpose

Hypertriglyceridemia

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Omega-3-acid ethyl esters 90 (TAK-085)

Eicosapentaenoic acid-ethyl (EPA-E)

About this trial

This is an interventional treatment trial for Hypertriglyceridemia focused on measuring Drug Therapy

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants with values of fasting triglyceride level at Visit 2 (Week -4) and Visit 3 (Week -2) are 150 mg/dL or higher and less than 750 mg/dL, and the difference between these 2 values is within 30% of the higher one.
Participants with differences between 2 values of fasting Low density lipoprotein - cholesterol level measured at Visit 2 (Week -4) and Visit 3 (Week -2) are within 25% of the higher one.

Exclusion Criteria:

Participants who have coronary artery diseases (eg, confirmed myocardial infarction and angina pectoris) within 6 months prior to Visit 1 (Week -8) or participants with a history of revascularization.
Participants who received aortic aneurysmectomy or is complicated with aortic aneurysm within 6 months prior to Visit 1 (Week -8).
Participants who have a history or complication of a clinically significant hemorrhagic disease (eg, hemophilia, capillary fragility illness, digestive tract ulcer, urinary tract hemorrhage, hemoptysis, vitreous haemorrhage and so forth) within 6 months prior to Visit 1 (Week -8).
Participants who have been diagnosed with pancreatitis.
Participants who have been diagnosed with lipoprotein lipase (LPL) deficiency, apolipoprotein C-II deficiency or type III familial hyperlipidemia.
Participants with complication of Cushing's syndrome, uremia, systemic lupus erythematosus (SLE) or serum dysproteinemia.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

TAK-085 2 g

TAK-085 4 g

EPA-E 1.8 g

Arm Description

TAK-085 2 g, orally, once daily for up to 12 weeks.

TAK-085 2 g, orally, twice daily for up to 12 weeks.

Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Triglyceride Level at the Final Visit

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 Outcome Measures

Percent Change From Baseline in Triglyceride Level Over Time

The percentage change between triglycerides collected at each study visit relative to Baseline.

Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time

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.

Percent Change From Baseline in Total Cholesterol Over Time

The percentage change between total cholesterol measured at each study visit relative to Baseline.

Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time

The percentage change between high-density lipoprotein cholesterol collected at each study visit relative to Baseline.

Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time

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.

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs

Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis

Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings After Study Drug Administration

Full Information

NCT ID

NCT01350973

First Posted

May 9, 2011

Last Updated

July 28, 2016

Sponsor

Takeda

1. Study Identification

Unique Protocol Identification Number

NCT01350973

Brief Title

Efficacy of TAK-085 in Participants With Hypertriglyceridemia

Official Title

A Phase 3, Multicenter, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of TAK-085 in Subjects With Hypertriglyceridemia.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Takeda

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study was to determine the efficacy and safety of TAK-085, once daily (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily (TID) in participants with hypertriglyceridemia undergoing lifestyle modification.

Detailed Description

TAK-085 is an oral capsule medicine licensed to Takeda Pharmaceutical Company Ltd. TAK-085 contains omega-3 fatty acid ethyl (mainly, ethyl eicosapentaenoate (EPA-E) and ethyl docosahexaenoic acid (DHA-E)). This is a phase 3, double-blind, randomized study to evaluate the efficacy and safety of TAK-085 compared to EPA-E in participants with hypertriglyceridemia who are undergoing lifestyle modification. The study period is a total of 20 weeks, comprised of an 8- week screening period and 12 weeks of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertriglyceridemia

Keywords

Drug Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

611 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TAK-085 2 g

Arm Type

Experimental

Arm Description

TAK-085 2 g, orally, once daily for up to 12 weeks.

Arm Title

TAK-085 4 g

Arm Type

Experimental

Arm Description

TAK-085 2 g, orally, twice daily for up to 12 weeks.

Arm Title

EPA-E 1.8 g

Arm Type

Experimental

Arm Description

Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Omega-3-acid ethyl esters 90 (TAK-085)

Other Intervention Name(s)

LOVAZA, Omacor

Intervention Description

Omega-3-acid ethyl esters 90 (TAK-085) capsules. Each one gram of fatty acid in TAK-085 contains approximately 465 mg of EPA plus 375 mg of docosahexaenoic acid-ethyl as ethyl esters.

Intervention Type

Drug

Intervention Name(s)

Eicosapentaenoic acid-ethyl (EPA-E)

Other Intervention Name(s)

Atheropan®

Intervention Description

EPA-E, 0.6 g, orally, three-times daily for up to 12 weeks.

Primary Outcome Measure Information:

Title

Percent Change From Baseline in Triglyceride Level at the Final Visit

Description

Time Frame

Baseline and 12 weeks

Secondary Outcome Measure Information:

Title

Percent Change From Baseline in Triglyceride Level Over Time

Description

The percentage change between triglycerides collected at each study visit relative to Baseline.

Time Frame