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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
Approved for 5 Other Conditions
All Individual Drugs Already Approved
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
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 • NCT012425279%
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
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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
4,394 Previous Clinical Trials
289,120,893 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
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