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

Tracking Information

First Received Date ^ICMJE

September 8, 2009

Last Updated Date

September 9, 2009

Start Date ^ICMJE

September 2009

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00972829 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hypercholesterolemia

Intervention ^ICMJE

Drug: Rosuvastatin
Rosuvastatin 10 or 20 milligrams once or twice a week

Other Name: Crestor
Drug: Ezetimibe
Ezetimibe 5 or 10 milligrams

Other Name: Zetia

Study Arms / Comparison Groups

Crestor: Experimental
Crestor 10 or 20 milligrams

Intervention: Drug: Rosuvastatin
Ezetimibe: Active Comparator
Ezetimibe 5 or 10 milligrams

Intervention: Drug: Ezetimibe

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2011

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00972829

Responsible Party

Lawrence Baruch, MD, James J. Peters VA Medical Center

Study ID Numbers ^ICMJE

BAR-09-07

Study Sponsor ^ICMJE

Bronx VA Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Lawrence Baruch, MD

James J.Peters VA Medical Center

Information Provided By

Bronx VA Medical Center

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP