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Crossover of Higher Dose Statins in Patients With Low High-density Lipoproteins Cholesterol (HDLc)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00736463
Recruitment Status : Unknown
Verified August 2008 by Oregon Health and Science University.
Recruitment status was:  Recruiting
First Posted : August 15, 2008
Last Update Posted : July 22, 2011
Merck Sharp & Dohme Corp.
Oregon State University
Indiana University
Information provided by:
Oregon Health and Science University

Brief 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 HDLc which are accentuated in patients with a low baseline HDLc. Higher doses of statins are being used more commonly in practice based on newer outcomes studies which find greater benefits of the higher doses compared to lower or standard doses. This study is testing FDA approved dosages of two commonly used statin medications.

Design: The study is designed to examine the effects of 80mg simvastatin and 80mg atorvastatin on HDLc concentrations. Serum will be saved for a hopeful collaborative effort with investigators at the U. of Washington who are able to do more advanced testing of HDL particle functionality. Based on the first 13 patients studied at Indiana University, the effects of these statins on HDLc concentrations vary greatly. It is unknown what impact these concentration changes have on the functionality of the particles however. A meta-analysis of 4 prospective trials published in JAMA in 2006 found that increasing HDLc with statins was independently associated with regression of atherosclerosis as measured by intravascular ultrasound.

Patients: Patients with low HDLc will be the primary population recruited. Exclusion criteria include interacting medications, pregnancy, baseline hepatic disease or other illnesses which would put patients at increased risk of statin side effects.

Condition or disease Intervention/treatment Phase
HDL Cholesterol Drug: Simvastatin Drug: Atorvastatin 80 mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of High Dose Simvastatin vs. Atorvastatin on Baseline Lipoprotein Profiles, Apo-A-1 and C Reactive Protein
Study Start Date : January 2005
Estimated Primary Completion Date : January 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Aimvastatin 80 mg
Drug: Simvastatin
One arm of randomized crossover

Active Comparator: 2
Atorvastatin 80 mg
Drug: Atorvastatin 80 mg
Second arm of randomized crossover

Primary Outcome Measures :
  1. HDL cholesterol [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. HS-CRP, apolipoprotein A1 and B [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00736463

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Contact: Craig D Williams, PharmD 503-494-1598
Contact: Darlene Kitterman 503-494-6263

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United States, Oregon
OHSU Hospital Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Craig D Williams, PharmD         
Sponsors and Collaborators
Oregon Health and Science University
Merck Sharp & Dohme Corp.
Oregon State University
Indiana University
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Principal Investigator: Craig D Williams Oregon Health and Science University
Additional Information:
Publications of Results:
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Responsible Party: Craig D. Williams, Pharm.D. Clinical Associate Professor, OHSU/OSU School of Pharmacy Identifier: NCT00736463    
Other Study ID Numbers: IRB00004506
First Posted: August 15, 2008    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: August 2008
Keywords provided by Oregon Health and Science University:
HDL cholesterol
patients with low baseline HDL cholesterol
Additional relevant MeSH terms:
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Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors