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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

Tracking Information
First Submitted Date  ICMJE September 8, 2009
First Posted Date  ICMJE September 9, 2009
Last Update Posted Date September 10, 2009
Study Start Date  ICMJE September 2009
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2009)
  • Low-density lipoprotein (LDL) cholesterol [ Time Frame: 6 weeks ]
  • Low-density lipoprotein (LDL) cholesterol [ Time Frame: 3-4 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2009)
  • Low-density lipoprotein (LDL) cholesterol [ Time Frame: 6 weeks ]
  • LDL cholesterol [ Time Frame: 3-4 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2009)
The ability to remain on Crestor for the study period [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2009)
Tolerability [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tolerability and Lipid Lowering Effect of Weekly/Biweekly Crestor in Statin Intolerant Patients Treated With Zetia
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Crestor
    Crestor 10 or 20 milligrams
    Intervention: Drug: Rosuvastatin
  • Active Comparator: Ezetimibe
    Ezetimibe 5 or 10 milligrams
    Intervention: Drug: Ezetimibe
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 8, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2011
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00972829
Other Study ID Numbers  ICMJE BAR-09-07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lawrence Baruch, MD, James J. Peters VA Medical Center
Study Sponsor  ICMJE Bronx VA Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lawrence Baruch, MD James J.Peters VA Medical Center
PRS Account Bronx VA Medical Center
Verification Date September 2009

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