[E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL

Cardiovascular Disease Clinical Trial

— ESPRIT  

Official title:

A 6-Week, Randomized, Double-Blind, Placebo(Olive Oil)-Controlled Study to Assess the Efficacy and Safety of Add-On Epanova® to Statin Therapy in Subjects With Persistent Hypertriglyceridemia and High Risk for Cardiovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408303
• Other study ID #: OM-EPA-004
• Secondary ID: OM-EPA-004
• Status: Completed
• Phase: Phase 3
• First received: August 1, 2011
• Last updated: November 27, 2014
• Start date: August 2011
• Est. completion date: June 2012

Study information

• Verified date: November 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective is to evaluate the efficacy of adding Epanova (2 g or 4 g daily) to an optimal statin monotherapy for lowering non-high-density lipoprotein (non-HDL) cholesterol in subjects with persistent hypertriglyceridemia and high risk for cardiovascular disease.

Description:

The primary efficacy variable is serum non-HDL cholesterol. The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in non-HDL cholesterol between placebo and the 2g/day and 4g/day Epanova groups. Baseline is defined as the average of Visits 2, 3 and 4 (Weeks -2, -1 and 0) and end-of-treatment is the average of Visits 5 and 6 (Weeks 5 and 6).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 646
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Men or women, =18 years of age.

2. Fasting triglyceride (TG) level =200 mg/dL and <500 mg/dL.

3. The subject is a high risk for a future cardiovascular event.

4. The subject is treated with a statin and at or near LDL-C goal.

Exclusion Criteria:

1. Allergy or intolerance to omega-3 fatty acids and omega-3-acid ethyl esters.

2. Use of fibrates, bile acid sequestrants, or niacin or its analogues (greater than 200 mg/d) during screening.

3. Use of simvastatin 80 mg or Vytorin10/80 mg during screening.

4. Use of any eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA) products.

5. Use of any supplement for the purpose of lowering plasma cholesterol during screening.

6. Use of weight loss drugs or programs during screening.

7. Use of erythromycin, telithromycin, clarithromycin, cyclosporine, itraconazole, ketoconazole, protease inhibitors, or nefazodone during screening.

8. Use of anticoagulants during screening.

9. Use of oral or injected corticosteroids during screening.

10. Use of tamoxifen, estrogens, progestins, or testosterone, that has not been stable for >4 weeks at Visit 1, or is unstable during screening.

11. Use of >750 mL/d grapefruit juice during screening.

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

13. History of pancreatitis.

14. Type I diabetes mellitus, use of insulin, or HbA1c >10% at Visit 1.

15. Poorly controlled hypertension

16. Uncontrolled hypothyroidism, or thyroid stimulating hormone (TSH) >1.5xULN at Visit 2.

17. Recent history or current significant nephrotic syndrome, pulmonary, hepatic, biliary, gastrointestinal or immunologic disease.

18. History of cancer (except non-melanoma skin cancer, or carcinoma in situ of cervix) within the previous two years.

19. Females who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are not using an acceptable method of contraception.

20. Creatine kinase >5.0 times upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times ULN at Visit 2.

21. Current or recent history (past 12 months) of drug or alcohol abuse.

22. Exposure to any investigational agent within 4 weeks prior to Visit 1.

23. 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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Hypertriglyceridemia

Intervention

Drug:
• Olive oil, 4g
Olive oil: 4 x 1 g capsule daily for 6 weeks + prescription statin
• omega-3-carboxylic acids, 2g
Epanova: 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks + prescription statin
• omega-3-carboxylic acids, 4g
Epanova: 4 x 1 g capsule daily for 6 weeks + prescription statin

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
AstraZeneca	Medpace, Inc., Omthera Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Non-HDL Cholesterol	The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in non-HDL cholesterol between placebo and the 2g/day and 4g/day Epanova groups.	6 weeks	No