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Omega-3 Fatty Acid

Epanova 2 g for Hypertriglyceridemia (EVOLVE Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

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.

Eligible Conditions
  • Hypertriglyceridemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fasting Serum Triglycerides

Side effects data

From 2012 Phase 2 & 3 trial • 399 Patients • NCT01242527
9%
Nausea
6%
Diarrhoea
3%
Nasopharyngitis
1%
Angina pectoris
1%
Pulmonary embolism
1%
Coronary artery disease
1%
Implantable defibrillator insertion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olive Oil (Placebo)
Epanova 3 g
Epanova 4 g
Epanova 2 g

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Epanova 4 gExperimental Treatment1 Intervention
Group II: Epanova 3 gExperimental Treatment1 Intervention
Group III: Epanova 2 gExperimental Treatment1 Intervention
Group IV: placeboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omega-3-carboxylic acids
FDA approved

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,368 Previous Clinical Trials
288,736,300 Total Patients Enrolled
12 Trials studying Hypertriglyceridemia
15,674 Patients Enrolled for Hypertriglyceridemia
Michael H Davidson, MD, FACCStudy DirectorOmthera Pharmaceuticals, Inc
4 Previous Clinical Trials
890 Total Patients Enrolled
3 Trials studying Hypertriglyceridemia
750 Patients Enrolled for Hypertriglyceridemia
~27 spots leftby Oct 2025
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