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Crossover of Higher Dose Statins in Patients With Low High-Density Lipoproteins Cholesterol (HDLc)
This study is currently recruiting participants.
Verified by Oregon Health and Science University, August 2008
Sponsors and Collaborators: Oregon Health and Science University
Merck
Oregon State University
Indiana University
Information provided by: Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00736463
  Purpose

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 Intervention Phase
HDL Cholesterol
Drug: Simvastatin
Drug: Atorvastatin 80 mg
Phase IV

MedlinePlus related topics: Cholesterol Statins
Drug Information available for: Atorvastatin Atorvastatin calcium Simvastatin Cholest-5-en-3-ol (3beta)- BaseLine
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title: Effects of High Dose Simvastatin vs. Atorvastatin on Baseline Lipoprotein Profiles, Apo-A-1 and C Reactive Protein

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • HDL cholesterol [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HS-CRP, apolipoprotein A1 and B [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2005
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Aimvastatin 80 mg
Drug: Simvastatin
One arm of randomized crossover
2: Active Comparator
Atorvastatin 80 mg
Drug: Atorvastatin 80 mg
Second arm of randomized crossover

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736463

Contacts
Contact: Craig D Williams, PharmD 503-494-1598 williacr@ohsu.edu
Contact: Darlene Kitterman 503-494-6263 kitterma@ohsu.edu

Locations
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
Oregon State University
Indiana University
Investigators
Principal Investigator: Craig D Williams Oregon Health and Science University
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Publications of Results:
Responsible Party: OHSU/OSU School of Pharmacy ( Craig D. Williams, Pharm.D. Clinical Associate Professor )
Study ID Numbers: IRB00004506
Study First Received: August 14, 2008
Last Updated: August 14, 2008
ClinicalTrials.gov Identifier: NCT00736463  
Health Authority: United States: Food and Drug Administration

Keywords provided by Oregon Health and Science University:
HDL cholesterol
statin
inflammation
atherosclerosis
prevention
patients with low baseline HDL cholesterol

Study placed in the following topic categories:
Atherosclerosis
Simvastatin
Atorvastatin
Inflammation

Additional relevant MeSH terms:
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009