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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
  Purpose

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.

Condition Intervention Phase
Hypercholesterolemia
Drug: Simvastatin
Drug: Ezetimibe
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 4 Study on Effect of Ezetimibe on Platelet Aggregation and LDL Tendency to Peroxidation In Hypercholesterolemic Patients on Simvastatin

Resource links provided by NLM:


Further study details as provided by Ziv Hospital:

Estimated Enrollment: 20
Study Start Date: February 2005
Study Completion Date: August 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00466401

Locations
Israel
Internal Medicine Department A ,Ziv Goverment Hospital
Safed, Israel, 13100
Sponsors and Collaborators
Ziv Hospital
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Osamah Hussein, MD Ziv Hospital
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00466401     History of Changes
Other Study ID Numbers: HP-5-155-S
Study First Received: April 25, 2007
Last Updated: February 19, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Simvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014