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Phase 4 N=32 Randomized Double-blind Treatment

Effects of Prescription Omega-3 on LDL-C in Primary Hypercholesterolemia

Primary Hypercholesterolemia

Bottom Line

View on ClinicalTrials.gov: NCT00746811 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Percent Change From Baseline in LDL-C During Each Treatment — 3.4; -0.7 Percent change from baseline

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
P-OM3 (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Provident Clinical Research
Primary completion
Jul 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Percent Change From Baseline in LDL-C During Each Treatment		 3.4; -0.7 —
SECONDARY
Percent Changes in Other Lipid and Biomarker Levels		 0.5; -0.7; -16.7; 2.0; 1.5; -1.7 —

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.

Eligibility Criteria

Inclusion Criteria

  • Men and women, ages 18-79 inclusive
  • Fasting, untreated low-density lipoprotein cholesterol (LDL-C)level in the borderline high to very high range
  • Fasting, untreated triglyceride (TG)level in the normal range
  • Provide written informed consent and authorization for protected health information

Exclusion Criteria

  • CHD or CHD risk equivalent
  • Pregnancy
  • Use of lipid altering medications which cannot be stopped
  • Body mass index over 45 kg per square meter
  • Allergy or sensitivity to omega-3 fatty acids
  • Certain muscle, liver, kidney, lung or gastrointestinal conditions
  • Poorly controlled hypertension
  • Certain medications
  • Active cancers treated within prior 2 years (except non-melanoma skin cancer)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00746811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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