Long-term Efficacy and Safety Study of TAK-085 in Participants With Hypertriglyceridemia

NCT01350999 | Completed Phase 3 Results

• 4 other identifiers: TAK-085/OCT-001JapicCTI-090936U1111-1120-7892JapicCTI-R140451
• Study Type: interventional
• Target: 503
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the safety and efficacy 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 (5)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  52 Weeks

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

  52 Weeks

• Number of Participants With TEAEs Associated With Abnormal Changes in Body Weight

  52 Weeks

• Number of Participants With Clinically Significant Findings in Electrocardiogram After Study Drug Administration

  Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure.

  52 Weeks

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

  52 Weeks

Secondary Outcomes (5)

• Percent Change From Baseline in Triglyceride Level

  Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

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

  Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

• Percent Change From Baseline in Total Cholesterol

  Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

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

  Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

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

  Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

Study Arms (3)

TAK-085 2 g

EXPERIMENTAL

TAK-085 2 g, orally, once daily for up to 52 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 52 weeks.

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

EPA-E 1.8 g

ACTIVE COMPARATOR

Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.

Drug: Eicosapentaenoic acid-ethyl (EPA)

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) DRUG

EPA-E capsules

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:

• Visit 1 (Week -4)
• Undergoing lifestyle modification.
• Triglyceride (TG) level (fasting state) 150 mg/dL or higher and less than 750 mg/dL at Visit 1 (Week -4).
• Both genders, aged from 20 to less than 75 years at the time of signing informed consent.
• Outpatient.
• Capable of understanding and complying with protocol requirements.
• Signed a written, informed consent form prior to the initiation of any study procedures.
• A female with childbearing potential (premenopausal and non-sterilized) must have agreed to use routinely adequate contraception from signing of informed consent throughout the duration of the study.
• Visit 2 (Week -2)
• Fasting TG level 150 mg/dL or higher and less than 750 mg/dL at Visit 2 (Week -2).
• Difference in fasting low density lipoprotein-cholesterol (LDL-C) level between Visit 1 (Week -4) and Visit 2 (Week -2) within 25% of the higher value

You may not qualify if:

• Visit 1 (Week -4)
• Any coronary artery diseases (CAD, e.g., confirmed myocardial infarction and angina pectoris) within 6 months prior to Visit 1 (Week -4) or a history of revascularization.
• Received aortic aneurysmectomy or had had aortic aneurysm within 6 months prior to Visit 1 (Week -4).
• History or complication of a clinically significant hemorrhagic disease (e.g., hemophilia, capillary fragility illness, digestive tract ulcer, urinary tract haemorrhage, hemoptysis, vitreous haemorrhage) within 6 months prior to Visit 1 (Week -4).
• Diagnosed with pancreatitis.
• Diagnosed with lipoprotein lipase (LPL) deficiency, apolipoprotein C-II deficiency or type III familial hyperlipidemia.
• Cushing's syndrome, uremia, systemic lupus erythematosus (SLE) or serum dysproteinemia.
• Type 1 diabetes mellitus or with uncontrolled type 2 diabetes mellitus defined by glycosylated hemoglobin (HbA1C) level of 8.0% or higher at Visit 1 (Week -4).
• Stage III hypertension defined by systolic blood pressure of 180 mmHg or higher or diastolic blood pressure of 110 mmHg or higher regardless of the use of antihypertensive medication.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level at Visit 1 (Week -4) was not less than twice the upper limit of the normal reference range.
• If female, was pregnant or lactating.
• Habitual drinking defined by an average daily alcohol intake of 100 mL or more , drug abuse or drug dependency, or a history of any of these conditions.
• Started to take any antihyperlipidemic drugs within 4 weeks prior to Visit 1 (Week -4).
• Received any investigational products (including those for post-marketing clinical study) within 12 weeks prior to Visit 1 (Week -4).
• Received TAK-085 in a clinical study.

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: NONE
• 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: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: September 20, 2016
• Results First Posted: September 20, 2016

Record last verified: 2016-07