Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01242527
Other study ID # OM-EPA-003
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received November 15, 2010
Last updated June 27, 2013
Start date January 2011
Est. completion date April 2012

Study information

Verified date June 2013
Source Omthera Pharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationHungary: National Institute of PharmacyDenmark: Ethics CommitteeNetherlands: Medical Ethics Review Committee (METC)Russia: Ministry of Health of the Russian FederationIndia: Drugs Controller General of India
Study type Interventional

Clinical Trial Summary

The primary objective of the study is to determine the efficacy of Epanova (omefas) compared to placebo in lowering serum triglycerides in subjects with severe hypertriglyceridemia.


Recruitment information / eligibility

Status Completed
Enrollment 399
Est. completion date April 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Men or women, >=18 years of age.

- Very high serum TG values in the range >=500 mg/dL and <2000 mg/dL (>=5.65 mmol/L and <22.60 mmol/L)

Exclusion Criteria:

- Allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, or fish.

- Known lipoprotein lipase impairment or deficiency or apolipoprotein C-II deficiency or familial dysbetalipoproteinemia.

- Unable to discontinue use of omega-3 drugs/supplements.

- Unable to discontinue use of bile acid sequestrants, fibrates or niacin (other than niacin-containing vitamins <200 mg), or any supplement used to alter lipid metabolism.

- Women who are pregnant, lactating, or planning to become pregnant. Women of childbearing potential who are not using acceptable contraceptive methods.

- Use of tamoxifen, estrogens or progestins that has not been stable for >4 weeks prior to Visit 1.

- Use of oral or injected corticosteroids or anabolic steroids.

- History of pancreatitis.

- History of symptomatic gallstone disease, unless treated with cholecystectomy.

- Uncontrolled diabetes.

- Uncontrolled hypothyroidism or thyroid stimulating hormone (TSH).

- History of cancer (other than basal cell carcinoma) in the past 2 years.

- Cardiovascular event (i.e., myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient ischemic attack, unstable congestive heart failure requiring a change in treatment) or revascularization procedure within six months prior to Visit 1.

- Use of anticoagulants (e.g. warfarin [Coumadin®], coumarin, heparin, enoxaparin, clopidogrel).

- Presence of an aortic aneurysm or resection of an aortic aneurysm within six months prior to Visit 1.

- Recent history (within six months prior to Visit 1) or current significant nephrotic syndrome, pulmonary, hepatic, biliary, gastrointestinal or immunologic disease.

- Poorly controlled hypertension.

- Any of the following laboratory criteria: serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST), glucose, glomerular filtration rate (GFR), platelet count,or hemoglobin outside of study range.

- Recent history (past 12 months) of drug abuse or alcohol abuse.

- Exposure to any investigational product, within 4 weeks prior to Visit 1.

- Presence of any other condition the Investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
placebo
4 capsules (1g) daily for 12 weeks
omefas
2 capsules (1g) + 2 placebo daily for 12 weeks
omefas
3 capsules (1g) + 1 placebo daily for 12 weeks
omefas
4 capsules (1g)daily for 12 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Omthera Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Denmark,  Hungary,  India,  Netherlands,  Russian Federation,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fasting Serum Triglycerides The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in triglycerides between placebo and the 2g/day, 3g/day and 4g/day Epanova groups. 12 weeks No
See also
  Status Clinical Trial Phase
Completed NCT01208961 - Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation Phase 2
Completed NCT04541186 - Study to Explore the Efficacy and Safety of BIO89-100 in Subjects With Severe Hypertriglyceridemia Phase 2
Active, not recruiting NCT05079919 - A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia Phase 3
Completed NCT02189252 - An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis Phase 1
Active, not recruiting NCT01229566 - Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia Phase 3
Completed NCT03001817 - Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function Phase 3
Completed NCT03011450 - Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment Phase 3
Completed NCT05355402 - A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia Phase 2
Completed NCT04720534 - Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia Phase 2
Recruiting NCT06347016 - Study of Plozasiran in Adults With Severe Hypertriglyceridemia Phase 3
Recruiting NCT06347003 - Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia Phase 3
Withdrawn NCT04662528 - Safety and Efficacy of MAT9001(Omega-3-pentaenoic Acid) in Subjects With Triglycerides ≥500 mg/dL and <2000 mg/dL Phase 3
Recruiting NCT05852431 - To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia Phase 3
Completed NCT02944383 - A 12-Week Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects With Severe Hypertriglyceridemia Phase 2
Recruiting NCT05681351 - A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG) Phase 3
Recruiting NCT05552326 - A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia Phase 3
Withdrawn NCT01997268 - The Efficacy of EPA+DHA (SC401B) for Lowering Triglyceride Levels (≥ 500 mg/dL) Phase 3