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

Primary Hypercholesterolemia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746811
• Other study ID #: PRV-08007
• Status: Completed
• Phase: Phase 4
• Start date: January 2010
• Est. completion date: October 2010

Study information

• Verified date: May 2024
• Source: Provident Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypercholesterolemia
• Primary Hypercholesterolemia

Intervention

Drug:
• P-OM3
4 grams/day - 4 one gram capsules
• Placebo
4 grams/day - 4 one gram capsules

Locations

Country	Name	City	State
United States	Provident Clinical Research	Addison	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Provident Clinical Research	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Maki KC, Lawless AL, Kelley KM, Dicklin MR, Kaden VN, Schild AL, Rains TM, Marshall JW. Effects of prescription omega-3-acid ethyl esters on fasting lipid profile in subjects with primary hypercholesterolemia. J Cardiovasc Pharmacol. 2011 Apr;57(4):489-94 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in LDL-C During Each Treatment	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.	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).
Secondary	Percent Changes in Other Lipid and Biomarker Levels	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.	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).