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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

September 8, 2009
September 9, 2009
September 10, 2009
September 2009
December 2010   (Final data collection date for primary outcome measure)
  • Low-density lipoprotein (LDL) cholesterol [ Time Frame: 6 weeks ]
  • Low-density lipoprotein (LDL) cholesterol [ Time Frame: 3-4 months ]
  • Low-density lipoprotein (LDL) cholesterol [ Time Frame: 6 weeks ]
  • LDL cholesterol [ Time Frame: 3-4 months ]
Complete list of historical versions of study NCT00972829 on ClinicalTrials.gov Archive Site
The ability to remain on Crestor for the study period [ Time Frame: 12 months ]
Tolerability [ Time Frame: 12 months ]
Not Provided
Not Provided
 
Tolerability and Lipid Lowering Effect of Weekly/Biweekly Crestor in Statin Intolerant Patients Treated With Zetia
Not Provided
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: Rosuvastatin
    Rosuvastatin 10 or 20 milligrams once or twice a week
    Other Name: Crestor
  • Drug: Ezetimibe
    Ezetimibe 5 or 10 milligrams
    Other Name: Zetia
  • Experimental: Crestor
    Crestor 10 or 20 milligrams
    Intervention: Drug: Rosuvastatin
  • Active Comparator: Ezetimibe
    Ezetimibe 5 or 10 milligrams
    Intervention: Drug: Ezetimibe
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
Same as current
March 2011
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00972829
BAR-09-07
No
Not Provided
Not Provided
Lawrence Baruch, MD, James J. Peters VA Medical Center
Bronx VA Medical Center
Not Provided
Principal Investigator: Lawrence Baruch, MD James J.Peters VA Medical Center
Bronx VA Medical Center
September 2009

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