To Study the Effect of Vytorin on Intracellular Lipid and Inflammation in Obese Subjects

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study focuses on the use of Vytorin to study inflammatory markers in subjects with normal cholesterol.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kaleida Health
• Treatments: Ezetimibe, Simvastatin Drug Combination; Simvastatin

Criteria

Inclusion Criteria:

1. Age 18-65years.

2. Obese BMI >30kg/m2

3. LDL cholesterol >100 mg/dl

4. Written and informed consent signed and dated 5. Not on any vitamin/antioxidants

Exclusion Criteria:

1. On any antilipid agents.

2. Triglyceride >500mg/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