Who is sponsoring ECLIPSEIII?

ECLIPSEIII is sponsored by AstraZeneca.

What condition does ECLIPSEIII study?

ECLIPSEIII studies Hypertriglyceridemia.

What drugs are being tested in ECLIPSEIII?

Interventions: rosuvastatin 40 mg tablet, Epanova™ QD (2 x 1 g capsules), Multiple doses of 4 g Epanova™ with single of rosuvastatin 40 mg dose, Multiple (20) oral doses of 2 g Vascepa® every 12 hours.

What is the status of ECLIPSEIII?

ECLIPSEIII is currently COMPLETED.

Last reviewed 2016-08-16 · How we verify

An Open-Label, 2-Cohort Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®), to Assess the Dose Proportionality of Epanova™, and to Compare the Systemic Exposure of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) Following Multiple Doses of Epanova™ and Vascepa® in Healthy Normal Subjects (ECLIPSEIII)

NCT02859129 Phase 1 COMPLETED

This study is intended to evaluate the potential 2-way reciprocal interaction between multiple doses of Epanova™ and a single dose of rosuvastatin

Details

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	COMPLETED
Enrolment	114
Start date	2013-09
Completion	2013-11

Conditions

Hypertriglyceridemia

Interventions

rosuvastatin 40 mg tablet
Epanova™ QD (2 x 1 g capsules)
Multiple doses of 4 g Epanova™ with single of rosuvastatin 40 mg dose
Multiple (20) oral doses of 2 g Vascepa® every 12 hours

Primary outcomes

ln-transformed Cmax,ss of baseline-adjusted total EPA, total DHA, and total EPA+DHA — Days 1 and 24
ln-transformed Cmax,ss of baseline-adjusted (primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total EPA+DHA using a linear mixed effect model.
ln-transformed AUC0-tau of baseline-adjusted total EPA, total DHA, and total EPA+DHA — Days 1 and 24
ln-transformed AUC0-tau of baseline-adjusted (primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total EPA+DHA using a linear mixed effect model.

Countries

United States