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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00972829
Enrollment
30
Registered
2009-09-09
Start date
2009-09-30
Completion date
2011-03-31
Last updated
2009-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

Hypercholesterolemia

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.

Interventions

DRUGRosuvastatin

Rosuvastatin 10 or 20 milligrams once or twice a week

DRUGEzetimibe

Ezetimibe 5 or 10 milligrams

Sponsors

Bronx VA Medical Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Low-density lipoprotein (LDL) cholesterol6 weeks

Secondary

MeasureTime frame
The ability to remain on Crestor for the study period12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026