Effect of Ezetimibe on Oxidized Low-density Lipoprotein (LDL) Cholesterol

Coronary Artery Disease Clinical Trial

Official title:

Effect of Ezetimibe on Oxidized LDL Cholesterol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01008345
• Other study ID #: pharmaline1
• Status: Completed
• Phase: Phase 4
• First received: November 4, 2009
• Last updated: November 5, 2009
• Start date: September 2008
• Est. completion date: June 2009

Study information

• Verified date: November 2009
• Source: Hotel Dieu de France Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lebanon: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Randomized study. Patients with coronary artery disease equivalent will be randomized to receive atorvastatin 40 mg/day + placebo vs. atorvastatin 40 mg/day + ezetimibe 40 mg/day. Oxidized LDL cholesterol will be measured at baseline and after 8 weeks of treatment. Hypothesis is that ezetimibe will lower oxidized LDL

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• CAD or CAD equivalent

Exclusion Criteria:

• Prior CABG or PCI within 3 months Prior use of ezetimibe within 3 months Receiving atorvastatin 40 mg/day or 80 mg/day or any dose of rosuvastatin CHF NYHA stage >2 Creatinin clearance < 30 ml/min

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes
• Myocardial Ischemia

Intervention

Drug:
• ezetimibe
Patients will receive 10 mg/day of ezetimibe for 8 weeks

Locations

Country	Name	City	State
Lebanon	Hotel Dieu de France Hospital	Achrafieh	Beirut

Sponsors (2)

Lead Sponsor	Collaborator
Hotel Dieu de France Hospital	Pharmaline, Lebanon

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of oxidized LDL cholesterol at end of study		8 weeks of treatment	No
Secondary	small dense LDL level		8 weeks of treatment	No