Effect of Ezetimibe on Platelet Aggregation and LDL Tendency to Peroxidation

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Ziv Hospital
ClinicalTrials.gov Identifier:
NCT00466401
First received: April 25, 2007
Last updated: February 19, 2013
Last verified: February 2013

April 25, 2007
February 19, 2013
February 2005
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Complete list of historical versions of study NCT00466401 on ClinicalTrials.gov Archive Site
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Effect of Ezetimibe on Platelet Aggregation and LDL Tendency to Peroxidation
Phase 4 Study on Effect of Ezetimibe on Platelet Aggregation and LDL Tendency to Peroxidation In Hypercholesterolemic Patients on Simvastatin

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 tendency to peroxidation in hypercholesterolemic patients on simvastatin therapy

The hypothesis is that:

  1. LDL lowering by ezetimibe on-top of simvastatin in patients on fixed dose of simvastatin can reduce platelet aggregation, due to the potential decreasing of cholesterol content in the platelet membranes.
  2. LDL lowering by ezetimibe can lower LDL tendency to peroxidation.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: Simvastatin
  • Drug: Ezetimibe
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2007
Not Provided

Inclusion Criteria:

  1. Hypercholesterolemic patients on stable simvastatin dose for at least one month.
  2. Age ≥18 years on stable AHA step 1 diet.
  3. 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
  4. Patients `on at least simvastatin treatment of 20 mg per day.
  5. CPK, ALT and AST < 1.5 X upper limit of normal at baseline.

Exclusion Criteria:

  1. Women currently receiving cyclical hormones.
  2. 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.
  3. Oral corticosteroids unless used as replacement therapy for pituitary/adrenal disease and a stable regimen for at least 6 weeks.
  4. Lipid lowering agents including fish oils and QUESTRAN taken within 6 weeks.
  5. Active coronary heart disease: unstable angina, acute myocardial infarction, CABG or PTCA within the last 3 months.
  6. Women with childbearing potential unless on safe contraception.
  7. Psychiatric disease with defect in judgement.
  8. Severe renal or hepatic disease.
  9. Uncontrolled hypo- or hyperthyroidism.
  10. 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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00466401
HP-5-155-S
Not Provided
Not Provided
Ziv Hospital
Merck Sharp & Dohme Corp.
Principal Investigator: Osamah Hussein, MD Ziv Hospital
Ziv Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP