Recruiting

Crestor with Zetia

Sponsor:

Bronx VA Medical Center

Code:

NCT00972829

Conditions

Hypercholesterolemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rosuvastatin

Ezetimibe

Study Details

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 ID

NCT00972829

Start date

Sep, 2009

Status verified date

Sep, 2009

Completion date

Mar, 2011

Anticipated

Primary completion date

Dec, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Crestor

Crestor 10 or 20 milligrams

active comparator: Ezetimibe

Ezetimibe 5 or 10 milligrams

Interventions

Rosuvastatin

Rosuvastatin 10 or 20 milligrams once or twice a week

Ezetimibe

Ezetimibe 5 or 10 milligrams

Primary outcome measure

  • Low-density lipoprotein (LDL) cholesterol [ Time Frame: 6 weeks ]
  • Low-density lipoprotein (LDL) cholesterol [ Time Frame: 3-4 months ]

Central Contacts and Locations

Locations

Bronx VA Medical Center

Recruiting

Bronx, New York, United States, 10468

Contacts

Lawrence Baruch, MD

718-584-9000lawrence.baruch@va.gov

Principal Investigator:

Lawrence Baruch, MD

More Information

Sponsor

Bronx VA Medical Center

Last update posted

Sep 10, 2009

Last verified

Sep, 2009

Keywords

  • Hypercholesterolemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bronx VA Medical Center on 2009-09-10.