Tolerability and Lipid Lowering Effect of Weekly/Biweekly Crestor in Statin Intolerant Patients Treated With Zetia
Information source: Bronx VA Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: Rosuvastatin (Drug); Ezetimibe (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Bronx VA Medical Center Official(s) and/or principal investigator(s):
Lawrence Baruch, MD, Principal Investigator, Affiliation: James J.Peters VA Medical Center
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.
Clinical Details
Study design: Treatment, Randomized, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Low-density lipoprotein (LDL) cholesterolLow-density lipoprotein (LDL) cholesterol
Secondary outcome: The ability to remain on Crestor for the study period
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Bronx VA Medical Center, Bronx, New York 10468, United States; Recruiting
Lawrence Baruch, MD, Phone: 718-584-9000, Ext: 5970, Email: lawrence.baruch@va.gov
Lawrence Baruch, MD, Principal Investigator
Additional Information
Starting date: September 2009
Ending date: March 2011
Last updated: September 9, 2009
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