Efficacy of TAK-085 in Participants With Hypertriglyceridemia

NCT01350973 | Completed Phase 3 Results

• 4 other identifiers: TAK-085/CCT-002JapicCTI-090937U1111-1120-7801JapicCTI-R140452
• Study Type: interventional
• Target: 611
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertriglyceridemia

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 12 weeks

Secondary Outcomes (9)

• Percent Change From Baseline in Triglyceride Level Over Time

  Baseline and Weeks 4, 8, 10 and 12

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

  Baseline and Weeks 4, 8, 10 and 12

• Percent Change From Baseline in Total Cholesterol Over Time

  Baseline and Weeks 4, 8, 10 and 12

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

  Baseline and Weeks 4, 8, 10 and 12

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

  Baseline and Weeks 4, 8, 10 and 12

Study Arms (3)

TAK-085 2 g

EXPERIMENTAL

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

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

TAK-085 4 g

EXPERIMENTAL

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

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

EPA-E 1.8 g

EXPERIMENTAL

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

Drug: Eicosapentaenoic acid-ethyl (EPA-E)

Interventions

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

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.

Also known as: LOVAZA, Omacor

TAK-085 2 g; TAK-085 4 g

Eicosapentaenoic acid-ethyl (EPA-E) DRUG

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

Also known as: Atheropan®

EPA-E 1.8 g

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

TAK-085; Omacor; eicosapentaenoic acid ethyl ester

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Associate Professor, Clinical Cell Biology and Medicine

  Graduate School of Medicine, Chiba University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2011
• First Posted: May 10, 2011
• Study Start: November 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 20, 2016
• Results First Posted: September 20, 2016

Record last verified: 2016-07