Status:
COMPLETED
Effect of Ezetimibe on Platelet Aggregation and LDL Tendency to Peroxidation
Lead Sponsor:
Ziv Hospital
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aim of our study is to Estimate the reduction of LDL by ezetimibe in hypercholesterolemic patients on simvastatin.Investigate the effect of LDL lowering by ezetimibe on platelet activity and LDL t...
Eligibility Criteria
Inclusion
- Hypercholesterolemic patients on stable simvastatin dose for at least one month.
- Age ≥18 years on stable AHA step 1 diet.
- Patients without CHD or with one risk factors ; LDL \> 130 mg/dL and for Patients with CHD or CHD risk equivalent(clinical manifestations of non-coronary forms of atherosclerotic disease) or with 2 risk f actors (cigarette smoking, hypertension (BP ≥140/90 mm Hg or on antihypertensive medication), low HDL cholesterol (\<40 mg/dL), family history of premature CHD;LDL\>100 mg/dL
- Patients 'on at least simvastatin treatment of 20 mg per day.
- CPK, ALT and AST \< 1.5 X upper limit of normal at baseline.
Exclusion
- Women currently receiving cyclical hormones.
- Treatment with psyllium, other fiber based laxatives, phytosterol margarines, or other OTCs that affect serum lipids, unless treated with a stable regimen for \> 6 weeks and the patient agrees to continue this regimen for the duration of the trial.
- Oral corticosteroids unless used as replacement therapy for pituitary/adrenal disease and a stable regimen for at least 6 weeks.
- Lipid lowering agents including fish oils and QUESTRAN taken within 6 weeks.
- Active coronary heart disease: unstable angina, acute myocardial infarction, CABG or PTCA within the last 3 months.
- Women with childbearing potential unless on safe contraception.
- Psychiatric disease with defect in judgement.
- Severe renal or hepatic disease.
- Uncontrolled hypo- or hyperthyroidism.
- Contraindication for ezetimibe or simvastatin treatment. The patients will continue on their treatment with simvastatin for 6 weeks, and then the patients will be treated by the same dose of simvastatin combined with ezetimibe 10 mg/day for other 6 weeks.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00466401
Start Date
February 1 2005
End Date
August 1 2007
Last Update
February 20 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Internal Medicine Department A ,Ziv Goverment Hospital
Safed, Israel, 13100