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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Bronx VA Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Bronx VA Medical Center
ClinicalTrials.gov Identifier:
NCT00972829
First received: September 8, 2009
Last updated: September 9, 2009
Last verified: September 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment

Resource links provided by NLM:


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
Experimental: Crestor
Crestor 10 or 20 milligrams
Drug: Rosuvastatin
Rosuvastatin 10 or 20 milligrams once or twice a week
Other Name: Crestor
Active Comparator: Ezetimibe
Ezetimibe 5 or 10 milligrams
Drug: Ezetimibe
Ezetimibe 5 or 10 milligrams
Other Name: Zetia

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Bronx VA Medical Center:
Hypercholesterolemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin
Ezetimibe
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014