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P-OM3 for High Cholesterol

Phase 4
Waitlist Available
Research Sponsored by Provident Clinical Research
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 baseline (average of weeks -1 and 0) and after 5 or 6 weeks of intervention (average of weeks 5 and 6 for the first treatment phase; average of weeks 11 and 12 for the second treatment phase).
Awards & highlights

Study Summary

The objectives of this study are to assess the effects of 4 g/d P-OM3, compared with placebo, on LDL-C and other aspects of the fasting lipid profile in subjects with primary hypercholesterolemia.

Eligible Conditions
  • High Cholesterol

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (average of weeks -1 and 0) and after 5 or 6 weeks of intervention (average of weeks 5 and 6 for the first treatment phase; average of weeks 11 and 12 for the second treatment phase).
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (average of weeks -1 and 0) and after 5 or 6 weeks of intervention (average of weeks 5 and 6 for the first treatment phase; average of weeks 11 and 12 for the second treatment phase). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change From Baseline in LDL-C During Each Treatment
Secondary outcome measures
Percent Changes in Other Lipid and Biomarker Levels

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo then P-OM3Experimental Treatment2 Interventions
Placebo (soy oil) for the first six weeks of treatment. P-OM3 (4 g/d) for the second six weeks of treatment.
Group II: P-OM3 then PlaceboExperimental Treatment2 Interventions
P-OM3 (4 g/d) for the first six weeks of treatment. Placebo (soy oil) for the second six weeks of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omega-3-acid ethyl esters
FDA approved
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineIndustry Sponsor
4,763 Previous Clinical Trials
8,104,681 Total Patients Enrolled
2 Trials studying High Cholesterol
112 Patients Enrolled for High Cholesterol
Provident Clinical ResearchLead Sponsor
14 Previous Clinical Trials
1,157 Total Patients Enrolled
Kevin C. Maki, PhDStudy DirectorProvident Clinical Research
3 Previous Clinical Trials
69 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Effects of Prescription Omega-3 on LDL-C in Primary Hypercholesterolemia
Kevin C. Maki, PhD 2010. "Effects of Prescription Omega-3 on LDL-C in Primary Hypercholesterolemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00746811.
~2 spots leftby May 2025
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