Hypercholesterolemia Clinical Trial
Official title:
Can Cholesterol Lowering Drugs Influence Circulating Omega-3 Fatty Acid Levels
The objective of this study is to determine if the administration of a cholesterol lowering
drug like ezetimibe will reduce circulating omega-3 fatty acid (ALA) levels in patients with
heart disease and hypercholesterolemia.
The investigators hypothesize that their data will discover that patients receiving
ezetimibe require additional dietary supplementation with omega-3 supplements to insure that
these beneficial fatty acids are available to these patients.
All patients will undergo drug therapy as required to treat their clinical symptoms
including the use of other classes of cholesterol-lowering drugs like statins (that will not
interfere with intestinal cholesterol levels). One group of patients will be those who in
addition to there existing drug therapy are prescribed ezetimibe to lower circulating
cholesterol concentrations. A second group of patients will be those who are not prescribed
ezetimibe as part of their normal course of therapy. Blood samples will be taken from all
patients at the study baseline. All patients will be fasted for 12 hours prior to the blood
sample being taken. After 6 weeks a second blood sample will be taken. This will determine
if the drug intervention (ezetimibe) influenced the circulating omega-3 fatty acid
concentration.
It will also be of interest to determine if drug administration (ezetimibe) will influence
this process when higher levels of omega-3 fatty acids are given to the patients by dietary
supplements of ALA. Two additional groups of patients will consume a flaxseed oil supplement
containing 1g of ALA in the form of two capsules daily
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Recruiting |
NCT03947866 -
Ezetimibe-Rosuvastatin Evaluation Study
|
||
Completed |
NCT01709513 -
Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)
|
Phase 3 | |
Completed |
NCT01212900 -
Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression
|
Phase 4 | |
Completed |
NCT00001154 -
Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins
|
||
Completed |
NCT02550288 -
A Clinical Trial to Assess the Efficacy and Safety of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-383)
|
Phase 3 | |
Completed |
NCT03929198 -
Translation of Pritikin Program to the Community
|
N/A | |
Completed |
NCT04485793 -
Effect of a Dietary Supplement on Lipid Pattern and Liver Parameters in Hypercholesterolemia
|
N/A | |
Completed |
NCT02341924 -
Validating the "Foods for Health" Portfolio of Functional Food Products
|
N/A | |
Active, not recruiting |
NCT02223793 -
Vascular Lifestyle-Intervention and Screening in Pharmacy
|
N/A | |
Completed |
NCT01941836 -
Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients
|
Phase 2 | |
Completed |
NCT01934608 -
The Effect of Synching Prescription Refills on Adherence
|
N/A | |
Recruiting |
NCT01705873 -
Analysis on the Risk of Cardiovascular Events in HIV- Infected Subjects Treated With LPV/r Based HAART Regimen vs. an EFV Based Regimen
|
N/A | |
Completed |
NCT01670734 -
Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects
|
Phase 1 | |
Completed |
NCT01678521 -
Effect of LDL-apheresis on PTX3 Plasma Levels in Hypercholesterolemic Patients
|
N/A | |
Completed |
NCT01370603 -
A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/40 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 40 mg Tablets in Participants With High Cholesterol (MK-0653C-190 AM1)
|
Phase 3 | |
Completed |
NCT01370590 -
A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/20 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 20 mg Tablets in Participants With High Cholesterol (MK-0653C-185 AM1)
|
Phase 3 | |
Completed |
NCT01575171 -
Using Nudges to Implement Comparative Effectiveness
|
N/A | |
Completed |
NCT01446679 -
Special Drug Use-Results Survey of Lipitor Tablets
|
N/A | |
Completed |
NCT01478789 -
Efficacy of Plant Sterol-Fortified Dairy Product on Plasma Lipid and Plant Sterol Concentrations in Humans
|
N/A |