Trial to Assess the Effects of P-OM3 on LDL-C in Subjects With Primary Hypercholesterolemia - Full Text View

Sponsors and Collaborators:	Provident Clinical Research GlaxoSmithKline
Information provided by:	Provident Clinical Research
ClinicalTrials.gov Identifier:	NCT00746811

Purpose

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.

Condition	Intervention	Phase
Primary Hypercholesterolemia	Drug: P-OM3 Drug: Placebo	Phase IV

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Omacor Cholest-5-en-3-ol (3beta)- Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	A Double-Blind, Randomized, Placebo-Controlled, Two-Period Crossover Trial to Assess the Effects of 4 g/d P-OM3 on LDL-C and Other Aspects of the Fasting Lipid Profile in Subjects With Primary Hypercholesterolemia

Further study details as provided by Provident Clinical Research:

Primary Outcome Measures:

The primary outcome variable will be the percent change from baseline in LDL-C during each treatment. [ Time Frame: Baseline to end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in other lipid and biomarker levels [ Time Frame: Baseline through end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	July 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 P-OM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment.	Drug: P-OM3 4 grams/day - 4 one gram capsules Drug: Placebo 4 grams/day - 4 one gram capsules
2 Placebo for the first six weeks of treatment. P-OM3 for the second six weeks of treatment.	Drug: P-OM3 4 grams/day - 4 one gram capsules Drug: Placebo 4 grams/day - 4 one gram capsules

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

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746811

Locations

United States, Illinois
Provident Clinical Research
Addison, Illinois, United States, 60101
United States, Indiana
Provident Clinical Research
Bloomington, Indiana, United States, 47403

Sponsors and Collaborators

Provident Clinical Research

GlaxoSmithKline

Investigators

Study Director:

Kevin C. Maki, PhD

Provident Clinical Research

More Information

Responsible Party:	Provident Clinical Research ( Kevin C. Maki, PhD, Chief Science Officer )
Study ID Numbers:	PRV-08007
Study First Received:	September 2, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00746811
Health Authority:	United States: Institutional Review Board

Keywords provided by Provident Clinical Research:

cholesterol
hypercholesterolemia
omega 3

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Metabolic disorder

Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on January 14, 2009