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

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ClinicalTrials.gov Identifier: NCT00746811
Recruitment Status : Unknown
Verified January 2010 by Provident Clinical Research.
Recruitment status was:  Recruiting
First Posted : September 4, 2008
Last Update Posted : January 28, 2010
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Provident Clinical Research

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.

Condition or disease Intervention/treatment Phase
Primary Hypercholesterolemia Drug: P-OM3 Drug: Placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : January 2010
Estimated Primary Completion Date : July 2010
Estimated Study Completion Date : October 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Other Name: Lovaza

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
Other Name: Lovaza

Drug: Placebo
4 grams/day - 4 one gram capsules




Primary Outcome Measures :
  1. The primary outcome variable will be the percent change from baseline in LDL-C during each treatment. [ Time Frame: Baseline to end of treatment ]

Secondary Outcome Measures :
  1. Changes in other lipid and biomarker levels [ Time Frame: Baseline through end of treatment ]


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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00746811


Locations
United States, Illinois
Provident Clinical Research Recruiting
Addison, Illinois, United States, 60101
Contact: John Marshall, RN, BSN    630-617-2000    research@providentcrc.com   
Sponsors and Collaborators
Provident Clinical Research
GlaxoSmithKline
Investigators
Study Director: Kevin C. Maki, PhD Provident Clinical Research

Responsible Party: Kevin C. Maki, PhD, Chief Science Officer, Provident Clinical Research
ClinicalTrials.gov Identifier: NCT00746811     History of Changes
Other Study ID Numbers: PRV-08007
First Posted: September 4, 2008    Key Record Dates
Last Update Posted: January 28, 2010
Last Verified: January 2010

Keywords provided by Provident Clinical Research:
cholesterol
hypercholesterolemia
omega 3

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases