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

Phase 4

• Conditions: Hypercholesterolemia
• Interventions: Drug: Rosuvastatin; Drug: Ezetimibe

• Registration Number: NCT00972829
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-09
• Study Start: 2009-09
• Study First Submitted: 2009-09-08
• Study First Submitted QC: 2009-09-08
• Study First Posted: 2009-09-09
• Last Update Submitted: 2009-09-09
• Last Update Posted: 2009-09-10
• Primary Completion: 2010-12
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crestor	Rosuvastatin	Crestor 10 or 20 milligrams
Ezetimibe	Ezetimibe	Ezetimibe 5 or 10 milligrams

Primary Outcome Measures

Name	Time	Method
Low-density lipoprotein (LDL) cholesterol	3-4 months

Secondary Outcome Measures

Name	Time	Method
The ability to remain on Crestor for the study period	12 months

Trial Locations

Locations (1)

Bronx VA Medical Center; 🇺🇸 Bronx, New York, United States