Status:
UNKNOWN
Crossover of Higher Dose Statins in Patients With Low High-density Lipoproteins Cholesterol (HDLc)
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Oregon State University
Conditions:
HDL Cholesterol
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Summary: Background: There is a lot of interest in the function and role of HDL to prevent and mitigate atherosclerosis in patients who are at or near LDLc targets. Statins have variable effects on H...
Detailed Description
The subject will be asked to come in for all study visits in a fasting state (only water for past 12 hours). Both blood pressure and pulse will be checked at the screening visit as well as all study v...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Screening visit HDL-c cholesterol \< 40 mg/dL (men) or \< 50 mg/dL (women)
- Screening visit LDL-c or non-HDL-c (for patients with TG 200-500 mg/dL) in range requiring therapy based on National Cholesterol Education Program (NCEP) guidelines
- Identifiable primary care provider
- Working phone number for follow-up
Exclusion
- Age \< 18 years
- Any unstable coronary disease (angina) at the screening visit or any acute coronary syndrome \< 6 months prior to first study visit
- Screening TG \> 750 mg/dL
- Known allergy or contraindication to atorvastatin or simvastatin
- Known HIV/AIDS diagnosis
- Screening alanine aminotransferase (ALT) \> 3 times upper lab reference range (ULR)
- Known history or diagnosis of clinical hepatic failure (example: variceal bleeding, ascites, INR\>1.3)
- Self-reported weekly alcohol intake of \> 2 drinks per day on average (e.g. \> 14 drinks/week)
- Self- reported pregnancy or current breastfeeding
- Use of a fibrate or niacin product or any other drug listed in the Zocor or Lipitor product package insert at a dose which causes a significant drug interaction
- Anticipated inability to complete the 4-visit study timeline for any reason (expected prolonged travel, extenuating medical needs, etc.)
- Active participation in another research protocol which would interfere with this trial
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00736463
Start Date
January 1 2005
Last Update
July 22 2011
Active Locations (1)
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1
OHSU Hospital
Portland, Oregon, United States, 97239