Status:
COMPLETED
Effects of Prescription Omega-3 on LDL-C in Primary Hypercholesterolemia
Lead Sponsor:
Provident Clinical Research
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Primary Hypercholesterolemia
Eligibility:
All Genders
18-79 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00746811
Start Date
January 1 2010
End Date
October 1 2010
Last Update
May 31 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Provident Clinical Research
Addison, Illinois, United States, 60101