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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Provident Clinical Research.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Provident Clinical Research
ClinicalTrials.gov Identifier:
NCT00746811
First received: September 2, 2008
Last updated: January 26, 2010
Last verified: January 2010
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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: January 2010
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: July 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
Other Name: Lovaza
Drug: Placebo
4 grams/day - 4 one gram capsules
Other Name: Placebo
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
Other Name: Placebo

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 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
  More Information

No publications provided

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
Study First Received: September 2, 2008
Last Updated: January 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Provident Clinical Research:
cholesterol
hypercholesterolemia
omega 3

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

ClinicalTrials.gov processed this record on April 17, 2014