Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02009865 | Epanova® for Lowering Very High Triglycerides II (EVOLVE II) | PHASE3 | COMPLETED | 379 | — | — | Dec 16, 2013 | Dec 23, 2014 | Sep 10, 2019 | 40 | United States, Canada +5 |
| NCT02859129 | Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®) | PHASE1 | COMPLETED | 114 | — | — | Sep 1, 2013 | Nov 1, 2013 | Aug 17, 2016 | 1 | United States |
This primary endpoint was tested in parallel together with the first of the secondary endpoints, each at 0.025 Type I error rate.
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 (primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total EPA+DHA using a linear mixed effect model.
| Arm | Type | Description |
|---|---|---|
| Epanova 2 g/day | EXPERIMENTAL | Arm 1 |
| Olive Oil 2 g/day | PLACEBO_COMPARATOR | Arm 2 |
| Rosuvastatin | EXPERIMENTAL | Single oral dose of 40 mg (1 x 40 mg tablet) rosuvastatin (Crestor®) (Day 1). |
| Epanova® | EXPERIMENTAL | Multiple oral doses of 2 g (2 x 1 g capsules) Epanova® QD for 10 consecutive days (Days 4 to 13) |
| Epanova® + Crestor® | EXPERIMENTAL | Epanova® multiple oral doses of 4 g (4 x 1 g capsules) QD for 13 consecutive days (Days 14 to 26) with coadministration of single 40 mg (1 x 40 mg tablet) oral dose of rosuvastatin (Crestor®) with the 11th dose of 4 g Epanova® on Day 24 |
| Vascepa® | ACTIVE_COMPARATOR | Vascepa® multiple oral doses of 2 g (2 x 1 g capsules) every 12 hours for 20 consecutive days (Days 1 to 20). |
| Name | Type | Description |
|---|---|---|
| Epanova | DRUG | Epanova will be provided in 1 g polyacrylate-coated soft gel capsules. Two capsules will be taken once per day, without regard to meals, for 12 weeks. At clinic visits, study drug will be administered at the clinic after fasting blood draws are complete. |
| Olive Oil | DRUG | Olive oil will be provided in 1 g polyacrylate-coated soft gel capsules. Two capsules will be taken once per day, without regard to meals, for 12 weeks. At clinic visits, study drug will be administered at the clinic after fasting blood draws are complete. |
| rosuvastatin 40 mg tablet | DRUG | Single oral dose of 40 mg (1 x 40 mg tablet) rosuvastatin (Crestor®) (Day 1). |
| Epanova™ QD (2 x 1 g capsules) | DRUG | Multiple oral doses of 2 g (2 x 1 g capsules) Epanova™ QD for 10 consecutive days (Days 4 to 13) |
| Multiple doses of 4 g Epanova™ with single of rosuvastatin 40 mg dose | DRUG | Multiple oral doses of 4 g Epanova™ QD for 13 consecutive days with coadministration of single 40 mg oral dose of rosuvastatin (Crestor®) with the 11th dose of Epanova™ on Day 24 |
| Multiple (20) oral doses of 2 g Vascepa® every 12 hours | DRUG | Multiple oral doses of 2 g (2 x 1 g capsules) Vascepa® every 12 hours for 20 consecutive days (Days 1 to 20). |
Inclusion Criteria: 1. Understanding of the study procedures, willingness to adhere to the study schedule, and agreement to participate in the study by giving written informed consent prior to screening; 2. Willing to use an appropriate and effective method of contraception; 3. Qualifying (average ...