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Completed

NCT Number: NCT00746811

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

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.

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Key information

Conditions

Primary Hypercholesterolemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Provident Clinical Research

Addison, Illinois, 60101, United States

About this study

This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 2 (Week 0), subjects meeting all entry criteria will be randomized to one of two treatment sequences: placebo or P-OM3 for the first 6 week phase followed by the study product they did not receive during the first phase (P-OM3 or placebo) for the second 6 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

P-OM3

Drug

4 grams/day - 4 one gram capsules

Other names: Lovaza

Placebo

Drug

4 grams/day - 4 one gram capsules

Primary outcomes

  1. Percent Change From Baseline in LDL-C During Each Treatment

    Time frame: 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).

    The primary outcome variable will be the percent change from baseline in LDL-C during each treatment.

    Baseline will be considered the average of values obtained at weeks -1 and 0. On-treatment values will be the average of values collected at weeks 5 and 6 for phase 1, and the average of values collected at weeks 11 and 12 for phase 2.

Secondary outcomes

  1. Percent Changes in Other Lipid and Biomarker Levels

    Time frame: 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).

    Percent changes from baseline in the levels of TC, HDL-C, non-HDL-C, VLDL-C, TG, TC/ HDL-C ratio and Apo AI and B.

    Baseline and on-treatment values for TC, HDL-C, non-HDL-C, VLDL-C, TG, TC/ HDL-C ratio will be calculated as described for LDL-C.

    Baseline values for Apo AI and B will include the average of values obtained at weeks -1 and 0. On-treatment values for Apo AI and B will be the average of values collected at weeks 6 and 12.

Sponsors and collaborators

Lead sponsor

Provident Clinical Research

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

A Double-blind, Randomized, Placebo-controlled, Two-period Crossover Trial to Assess the Effects of 4 g/d Prescription Omega-3 Ethyl Esters on Low-density Lipoprotein Cholesterol in Subjects With Primary Hypercholesterolemia

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 4, 2008
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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