NCT00746811

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 4, 2008

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
13.6 years until next milestone

Results Posted

Study results publicly available

May 8, 2024

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

September 2, 2008

Results QC Date

October 16, 2017

Last Update Submit

May 14, 2024

Conditions

Primary Hypercholesterolemia

Keywords

cholesterolhypercholesterolemiaomega 3

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Percent Changes in Other Lipid and Biomarker Levels

    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).

Study Arms (2)

P-OM3 then Placebo

OTHER

P-OM3 (4 g/d) for the first six weeks of treatment. Placebo (soy oil) for the second six weeks of treatment.

Drug: P-OM3Drug: Placebo

Placebo then P-OM3

OTHER

Placebo (soy oil) for the first six weeks of treatment. P-OM3 (4 g/d) for the second six weeks of treatment.

Drug: P-OM3Drug: Placebo

Interventions

P-OM3DRUG

4 grams/day - 4 one gram capsules

Also known as: Lovaza
P-OM3 then PlaceboPlacebo then P-OM3
PlaceboDRUG

4 grams/day - 4 one gram capsules

P-OM3 then PlaceboPlacebo then P-OM3

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Provident Clinical Research

Addison, Illinois, 60101, United States

Location

Related 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. doi: 10.1097/FJC.0b013e318210fca5.

    PMID: 21297494RESULT

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Omacor

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
John Marshall, General Manager
Organization
Biofortis Research (formerly Provident)
john.marshall@mxns.com
630-748-5339

Study Officials

  • Kevin C. Maki, PhD

    Provident Clinical Research

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director/Chief Science Officer

Study Record Dates

First Submitted

September 2, 2008

First Posted

September 4, 2008

Study Start

January 1, 2010

Primary Completion

July 1, 2010

Study Completion

October 1, 2010

Last Updated

May 31, 2024

Results First Posted

May 8, 2024

Record last verified: 2024-05

Locations

US(1)