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

(ESPRIT Trial)

Recruiting in Palo Alto (17 mi)

+81 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Michael H Davidson, MD, FACC

Principal Investigator

Omthera Pharmaceuticals, Inc

Eligibility Criteria

Inclusion Criteria

Men or women, ≥18 years of age.

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

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

Treatment Details

Interventions

• Olive oil (Other)
• Omega-3-carboxylic acids (Omega-3 Fatty Acid)

Participant Groups

Group I: Epanova, 4 g Experimental Treatment 1 Intervention

omega-3-carboxylic acids, 4g/day + prescription statin

Group II: Epanova, 2 g Experimental Treatment 1 Intervention

omega-3-carboxylic acids, 2g/day + prescription statin

Group III: Olive Oil Placebo Group 1 Intervention

olive oil: 4 g/day + prescription statin

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

NCT01408303 Lyndhurst, OH

NCT01408303 Harleysville, PA

NCT01408303 Oxon Hill, MD

NCT01408303 Tulsa, OK

More Trial Locations

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4491

Patients Recruited

290,540,000+

Medpace, Inc.

Industry Sponsor

Trials

98

Patients Recruited

30,400+

Omthera Pharmaceuticals, Inc

Industry Sponsor

Trials

1

Patients Recruited

650+