Clinical trial NCT00746811: Effects of Prescription Omega-3 on LDL-C in Primary Hypercholesterolemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Hypercholesterolemia
Keywords: cholesterol
hypercholesterolemia
omega 3
Lead sponsor: Provident Clinical Research
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2008-09-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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)

Primary outcomes:
measure: Percent Change From Baseline in LDL-C During Each Treatment
timeFrame: 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 outcomes:
measure: Percent Changes in Other Lipid and Biomarker Levels
timeFrame: 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).
Other outcomes:
Locations:
city: Addison
country: United States
facility: Provident Clinical Research
state: Illinois
Study officials:
affiliation: Provident Clinical Research
name: Kevin C. Maki, PhD
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1097/FJC.0b013e318210fca5.