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

Hypercholesterolemia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00972829
• Other study ID #: BAR-09-07
• Status: Recruiting
• Phase: Phase 4
• First received: September 8, 2009
• Last updated: September 9, 2009
• Start date: September 2009
• Est. completion date: March 2011

Study information

• Verified date: September 2009
• Source: Bronx VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Rosuvastatin
Rosuvastatin 10 or 20 milligrams once or twice a week
• Ezetimibe
Ezetimibe 5 or 10 milligrams

Locations

Country	Name	City	State
United States	Bronx VA Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bronx VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low-density lipoprotein (LDL) cholesterol		6 weeks	No
Primary	Low-density lipoprotein (LDL) cholesterol		3-4 months	No
Secondary	The ability to remain on Crestor for the study period		12 months	Yes