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

NCT ID: NCT00972829

Last Updated: 2009-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-03-31

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.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT

Study Groups

Crestor

Crestor 10 or 20 milligrams

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

Rosuvastatin 10 or 20 milligrams once or twice a week

Ezetimibe

Ezetimibe 5 or 10 milligrams

Group Type: ACTIVE_COMPARATOR

Ezetimibe

Intervention Type: DRUG

Ezetimibe 5 or 10 milligrams

Interventions

Rosuvastatin

Rosuvastatin 10 or 20 milligrams once or twice a week

Intervention Type: DRUG

Ezetimibe

Ezetimibe 5 or 10 milligrams

Intervention Type: DRUG

Other Intervention Names

Crestor; Zetia

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bronx VA Medical Center

FED

Sponsor Role: lead

Responsible Party

James J. Peters VA Medical Center

Principal Investigators

Lawrence Baruch, MD

Role: PRINCIPAL_INVESTIGATOR

James J.Peters VA Medical Center

Locations

Bronx VA Medical Center

The Bronx, New York, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Lawrence Baruch, MD

Role: primary

lawrence.baruch@va.gov

718-584-9000 ext. 5970

Other Identifiers

BAR-09-07

Identifier Type: -

Identifier Source: org_study_id