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Tolerability and Lipid Lowering Effect of Weekly/Biweekly Crestor in Statin Intolerant Patients Treated With Zetia

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ClinicalTrials.gov Identifier: NCT00972829
Recruitment Status : Unknown
Verified September 2009 by Bronx VA Medical Center.
Recruitment status was:  Recruiting
First Posted : September 9, 2009
Last Update Posted : September 10, 2009
Sponsor:
Information provided by:
Bronx VA Medical Center

Brief Summary:
Recently, research studies have shown that patients who have had trouble taking statins every day, are able to take statins if they take them only once or twice a week. The investigators are doing a research study which involves switching people who are taking ezetimibe to the statin Crestor once or twice a week and to see how ell Crestor lowers cholesterol and if it is tolerated.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Rosuvastatin Drug: Ezetimibe Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Study Start Date : September 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : March 2011


Arm Intervention/treatment
Experimental: Crestor
Crestor 10 or 20 milligrams
Drug: Rosuvastatin
Rosuvastatin 10 or 20 milligrams once or twice a week
Other Name: Crestor
Active Comparator: Ezetimibe
Ezetimibe 5 or 10 milligrams
Drug: Ezetimibe
Ezetimibe 5 or 10 milligrams
Other Name: Zetia



Primary Outcome Measures :
  1. Low-density lipoprotein (LDL) cholesterol [ Time Frame: 6 weeks ]
  2. Low-density lipoprotein (LDL) cholesterol [ Time Frame: 3-4 months ]

Secondary Outcome Measures :
  1. The ability to remain on Crestor for the study period [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a history of intolerance to statins
  • Patients currently receiving ezetimibe
  • Patients willing and able to provide signed informed consent

Exclusion Criteria:

  • Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol)
  • Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within 3 months
  • Cancer undergoing active treatment
  • Creatinine clearance < 40 ml/minute
  • Active liver disease or persistent elevation of SGOT or SGPT > 2 times the upper limit of normal level
  • Participation in any clinical study within the last 30 days
  • Drug addition or alcohol abuse within the past 6 months
  • Use of cyclosporine within the last 3 months
  • Use of gemfibrozil within the last month
  • Patients unwilling or unable to provide informed consent
  • Patients with poor compliance
  • Women of childbearing potential
  • History of rhabdomyolysis due to statins

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00972829


Locations
United States, New York
Bronx VA Medical Center Recruiting
Bronx, New York, United States, 10468
Contact: Lawrence Baruch, MD    718-584-9000 ext 5970    lawrence.baruch@va.gov   
Principal Investigator: Lawrence Baruch, MD         
Sponsors and Collaborators
Bronx VA Medical Center
Investigators
Principal Investigator: Lawrence Baruch, MD James J.Peters VA Medical Center

Responsible Party: Lawrence Baruch, MD, James J. Peters VA Medical Center
ClinicalTrials.gov Identifier: NCT00972829     History of Changes
Other Study ID Numbers: BAR-09-07
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: September 10, 2009
Last Verified: September 2009

Keywords provided by Bronx VA Medical Center:
Hypercholesterolemia

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