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

NCT00972829 | Unknown Phase 4

• 1 other identifier: BAR-09-07
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

• Low-density lipoprotein (LDL) cholesterol

  6 weeks

• Low-density lipoprotein (LDL) cholesterol

  3-4 months

Secondary Outcomes (1)

• The ability to remain on Crestor for the study period

  12 months

Study Arms (2)

Crestor

EXPERIMENTAL

Crestor 10 or 20 milligrams

Drug: Rosuvastatin

Ezetimibe

ACTIVE COMPARATOR

Ezetimibe 5 or 10 milligrams

Drug: Ezetimibe

Interventions

Rosuvastatin DRUG

Rosuvastatin 10 or 20 milligrams once or twice a week

Also known as: Crestor

Crestor

Ezetimibe DRUG

Ezetimibe 5 or 10 milligrams

Also known as: Zetia

Ezetimibe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a history of intolerance to statins
• Patients currently receiving ezetimibe
• Patients willing and able to provide signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Bronx VA Medical Center: lead

Study Sites (1)

Bronx VA Medical Center

The Bronx, New York, 10468, United States

RECRUITING

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Rosuvastatin Calcium; Ezetimibe

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azetidines; Azetines

Study Officials

• Lawrence Baruch, MD

  James J.Peters VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: September 8, 2009
• First Posted: September 9, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: September 10, 2009

Record last verified: 2009-09

Locations

US (1)