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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 through end of treatment
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to end of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The variable will be the percent change from baseline in LDL-C during each treatment.
Secondary outcome measures
Body Weight Changes
Trial Design
2Treatment groups
Experimental Treatment
Group I: 2Experimental Treatment2 Interventions
Placebo for the first six weeks of treatment. P-OM3 for the second six weeks of treatment.
Group II: 1Experimental Treatment2 Interventions
P-OM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineIndustry Sponsor
4,753 Previous Clinical Trials
8,069,656 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
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