Status:
TERMINATED
Ezetimibe in Patients Hypo-responsive to Statins
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
High Cholesterol
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Response to statin therapy for elevated low density lipoprotein is variable and may be influenced by cholesterol absorption. This study will evaluate whether combination therapy with atorvastatin/ezet...
Detailed Description
Specific Aim 1 To identify a patient population seen in the University of California, San Diego general internal medicine and cardiology subspecialty clinics as well as referrals from community physic...
Eligibility Criteria
Inclusion
- Patients will need to have an LDL-C level of 130 mg/dl or greater without treatment.
- They must have demonstrated an initial LDL-C reduction of less than 25% on 10 mg of atorvastatin or 20 mg of simvastatin.
- Eligible patients will be those deemed by their physicians to be eligible for lipid lowering therapy with a statin and to have stable CAD, CAD equivalent per NCEP guidelines, or Framingham risk of 10-20%.
Exclusion
- Recent (\<3 months) diagnosis of Acute Coronary Syndromes due to ethical considerations \[10\].
- Pregnant patients, those planning to become pregnant, or those who are breast feeding, those with liver disease, history allergic reaction to any agent used in the trial, history of myositis, myopathy, pancreatitis, hypertriglyceridemia (TG \> 400 mg/dL), history of significant alcohol or drug abuse, history of organ transplantation, or patient refusal.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00965055
Start Date
September 1 2009
End Date
September 1 2012
Last Update
August 21 2019
Active Locations (1)
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1
UCSD Medical Center in Hillcrest Clinical Trials Facility
San Diego, California, United States, 92103