Exploratory Study of the Effects of Omega-3-acid Ethyl Esters on the Lipid and Lipoprotein Profile in the Blood

NCT02839902 | Completed Phase 4 Results

• 3 other identifiers: TAK-085-4002U1111-1185-0054JapicCTI-163322
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to explore the effects of 8-week treatment with omega-3-acid ethyl esters on the lipid and lipoprotein profile in the blood in hyperlipidemic patients receiving a HMG-CoA reductase inhibitor by use of HPLC in comparison with the control group of patients not treated with omega-3-acid ethyl esters.

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (3)

• Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction

  Major 4 lipid constituents refer to cholesterol, triglycerides, free cholesterol, and phospholipid. The reported data are percent of change from baseline in concentration of the each lipid constituents in sdLDL fraction at Week 4 and Week 8.

  Baseline, Week 4 and Week 8

• Percent Changes From Baseline in Triglycerides (TG) to Cholesterol Ratio in sdLDL Fraction

  Reported data are percent of change from baseline in in TG to cholesterol ratio in sdLDL fraction at Week 4 and Week 8.

  Baseline, Week 4, and Week 8

• Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents

  Reported data are percent of change from baseline in mean particle sizes of sdLDL-C and LDL-C monitored by major 4 lipid constituents (cholesterol, triglycerides, free cholesterol, and phospholipid) at Week 4 and Week 8. Here the data were consolidated from results of the two outcome measures ("Change in mean particle sizes of sdLDL-C" and "Change in mean particle sizes of LDL-C") on initial registration information (see History of Change of registration) because sdLDL-C refers to LDL-C which is smaller particle size and heavier density.

  Baseline, Week 4, and Week 8

Secondary Outcomes (13)

• Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction

  Baseline, Week 4 and Week 8

• Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction

  Baseline, Week 4 and Week 8

• Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction

  Baseline, Week 4 and Week 8

• Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction

  Baseline, Week 4 and Week 8

• Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids

  Baseline, Week 4 and Week 8

Study Arms (2)

TAK-085 4g

EXPERIMENTAL

A dose of 2 g of omega-3-acid ethyl esters (TAK-085) capsule is orally administered immediately after meal twice a daily (totally 4g per a day) for 8 weeks, plus a stable HMG-CoA reductase inhibitor regimen (started ≥4 weeks prior to informed consent) at a consistent dose.

Drug: TAK-085

Control Group

EXPERIMENTAL

Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.

Other: Not treated with omega-3-acid ethyl esters

Interventions

TAK-085 DRUG

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

TAK-085 4g

Not treated with omega-3-acid ethyl esters OTHER

Not treated with omega-3-acid ethyl esters

Control Group

Eligibility Criteria

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

You may qualify if:

• Participants diagnosed as hyperlipidemia.
• Participants constantly receiving a HMG-CoA reductase inhibitor at a stable dose for at least 4 weeks at the start of the observation period.
• Participants with fasting TG of 150≤ to \<400 mg/dL measured at the start of the observation period at Visit 1 (Week -4).
• Participants who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical study and complying with the study protocol requirements.
• Participants who can provide written informed consent prior to the conduction of the clinical study procedures.
• Participants aged ≥20 years at the time of informed consent at Visit 1 (Week -4).

You may not qualify if:

• Participants who had clinically significant hemorrhagic disorders (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, and vitreous hemorrhage) within 24 weeks prior to the start of the observation period, or those who concurrently have the above disorders.
• Participants who had thyroid disorders (hyperthyroidism or hypothyroidism) within 24 weeks prior to the start of the observation period, those who concurrently have the above disorders, or those who are orally receiving a therapeutic drug for thyroid disorder.
• Participants in whom the type of HMG-CoA reductase inhibitors was changed within 12 weeks prior to the start of observation period.
• Participants who received an eicosapentaenoic acid (EPA) preparation or an EPA/docosahexaenoic acid (DHA) preparation (including supplements) within 12 weeks prior to the start of observation period.
• Participants who started antidyslipidemic agents within 4 weeks prior to the start of observation period.
• Participants with severe hepatic impairment (e.g., Child-Pugh classification C).
• Participants who were previously diagnosed as lipoprotein lipase deficiency or apoprotein C-II deficiency.
• Participants who are concurrently having Cushing's syndrome, uremia, systemic lupus erythematosus (SLE), or serum dysproteinemia.
• Diabetic participants who are currently receiving thiazolidine or insulin.
• Participants who are concurrently having hypertension of grade IIINote 1). Note 1: Participants with systolic blood pressure of ≥180 mm Hg or diastolic blood pressure of ≥110 mm Hg regardless of treatment with antihypertensive drugs.
• Participants who are habitual drinkers drinking an average of over 100 mL per day (expressed in terms of quantity of alcohol), or participants with or with a history of drug abuse or addiction.
• Pregnant, lactating or postmenopausal women.
• Participants with a history of hypersensitivity or allergy for omega-3-acid ethyl esters.
• Participants participating in other clinical studies.
• Participants assessed ineligible in the study by the principal investigator or the investigator.

Sponsors & Collaborators

• Takeda: lead

Study Sites (7)

Unknown Facility

Noda, Chiba, Japan

Location

Unknown Facility

Koga, Ibaragi, Japan

Location

Unknown Facility

Moriguchi, Osaka, Japan

Location

Unknown Facility

Suita, Osaka, Japan

Location

Unknown Facility

Fujimi, Saitama, Japan

Location

Unknown Facility

Mitaka, Tokyo, Japan

Location

Unknown Facility

Saitama, Japan

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

TAK-085; Omacor

Condition Hierarchy (Ancestors)

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

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 21, 2016
• Study Start: December 27, 2016
• Primary Completion: August 30, 2017
• Study Completion: August 30, 2017
• Last Updated: February 11, 2019
• Results First Posted: February 11, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

JP (7)