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

This study is currently recruiting participants.

Verified by Bronx VA Medical Center, September 2009

First Received: September 8, 2009 Last Updated: September 9, 2009 History of Changes

Sponsor:	Bronx VA Medical Center
Information provided by:	Bronx VA Medical Center
ClinicalTrials.gov Identifier:	NCT00972829

Purpose

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.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: Rosuvastatin Drug: Ezetimibe	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Statins

Drug Information available for: Rosuvastatin calcium Ezetimibe Rosuvastatin

U.S. FDA Resources

Further study details as provided by Bronx VA Medical Center:

Primary Outcome Measures:

Low-density lipoprotein (LDL) cholesterol [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Low-density lipoprotein (LDL) cholesterol [ Time Frame: 3-4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The ability to remain on Crestor for the study period [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	September 2009
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Crestor: Experimental Crestor 10 or 20 milligrams	Drug: Rosuvastatin Rosuvastatin 10 or 20 milligrams once or twice a week
Ezetimibe: Active Comparator Ezetimibe 5 or 10 milligrams	Drug: Ezetimibe Ezetimibe 5 or 10 milligrams

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972829

Locations

United States, New York
Bronx VA Medical Center	Recruiting
Bronx, New York, United States, 10468
Contact: Lawrence Baruch, MD 718-584-9000 ext 5970 lawrence.baruch@va.gov
Principal Investigator: Lawrence Baruch, MD

Sponsors and Collaborators

Bronx VA Medical Center

Investigators

Principal Investigator:

Lawrence Baruch, MD

James J.Peters VA Medical Center

More Information

No publications provided

Responsible Party:	James J. Peters VA Medical Center ( Lawrence Baruch, MD )
Study ID Numbers:	BAR-09-07
Study First Received:	September 8, 2009
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00972829 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Bronx VA Medical Center:

Hypercholesterolemia

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Ezetimibe
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Rosuvastatin
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010