Back to resultsTrial to Assess the Effects of P-OM3 on LDL-C in Subjects With Primary Hypercholesterolemia
Primary Purpose
Primary Hypercholesterolemia
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
P-OM3
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hypercholesterolemia focused on measuring cholesterol, hypercholesterolemia, omega 3
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)
Sites / Locations
- Provident Clinical ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1
2
Arm Description
P-OM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment.
Placebo for the first six weeks of treatment. P-OM3 for the second six weeks of treatment.
Outcomes
Primary Outcome Measures
The primary outcome variable will be the percent change from baseline in LDL-C during each treatment.
Secondary Outcome Measures
Changes in other lipid and biomarker levels
Full Information
NCT ID
NCT00746811
First Posted
September 2, 2008
Last Updated
January 26, 2010
Sponsor
Provident Clinical Research
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00746811
Brief Title
Trial to Assess the Effects of P-OM3 on LDL-C in Subjects With Primary Hypercholesterolemia
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 Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
October 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Provident Clinical Research
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypercholesterolemia
Keywords
cholesterol, hypercholesterolemia, omega 3
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
P-OM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment.
Arm Title
2
Arm Type
Other
Arm Description
Placebo for the first six weeks of treatment. P-OM3 for the second six weeks of treatment.
Intervention Type
Drug
Intervention Name(s)
P-OM3
Other Intervention Name(s)
Lovaza
Intervention Description
4 grams/day - 4 one gram capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
4 grams/day - 4 one gram capsules
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Changes in other lipid and biomarker levels
Time Frame
Baseline through end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin C. Maki, PhD
Organizational Affiliation
Provident Clinical Research
Official's Role
Study Director
Facility Information:
Facility Name
Provident Clinical Research
City
Addison
State/Province
Illinois
ZIP/Postal Code
60101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Marshall, RN, BSN
Phone
630-617-2000
Email
research@providentcrc.com
12. IPD Sharing Statement
Learn more about this trial
Trial to Assess the Effects of P-OM3 on LDL-C in Subjects With Primary Hypercholesterolemia
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