Overview
Anti-inflammatory Effects of Simvastatin
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2021-08-01
2021-08-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this research study is to determine which of the two ingredients of Vytorin (Simvastatin or Ezetimibe) is responsible for the anti-inflammatory effects of VytorinPhase:
Phase 4Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Paresh DandonaTreatments:
Ezetimibe
Simvastatin
Criteria
Inclusion Criteria:1. Age: 18 to 75 years of age.
2. Obese (BMI ≥30 kg/m2)
3. LDL cholesterol of ≥100 mg/dl
4. Not taking any vitamins or antioxidants
Exclusion Criteria:
1. Currently using anti-hyperlipidemic therapies
2. Triglycerides >500 mg/dl.
3. Myocardial infarction, angioplasty/stent placement or coronary artery bypass surgery
in the past 6 months.
4. Patient on chronic use of non-steroidal anti-inflammatory drugs or steroids
5. Hepatic disease
6. Renal impairment.
7. History of drug or alcohol abuse
8. Participation in any other concurrent clinical trial
9. Use of an investigational agent or therapeutic regimen within 30 days of study.
10. Smoker
11. Pregnancy
12. Premenopausal women who are not on birth control pills and have not had a hysterectomy
or tubal ligation
13. Anemia with hemoglobin <12 g/dl