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

B

Bronx VA Medical Center

Status and phase

Unknown
Phase 4

Conditions

Hypercholesterolemia

Treatments

Drug: Rosuvastatin
Drug: Ezetimibe

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00972829
BAR-09-07

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

Crestor
Experimental group
Description:
Crestor 10 or 20 milligrams
Treatment:
Drug: Rosuvastatin
Ezetimibe
Active Comparator group
Description:
Ezetimibe 5 or 10 milligrams
Treatment:
Drug: Ezetimibe

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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