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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Oregon Health and Science University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Oregon State University
Indiana University
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00736463
First received: August 14, 2008
Last updated: July 20, 2011
Last verified: August 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
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, see Learn About Clinical Studies.

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 Sharp & Dohme Corp.
Oregon State University
Indiana University
Investigators
Principal Investigator: Craig D Williams Oregon Health and Science University
  More Information

Additional Information:
Publications:
Responsible Party: Craig D. Williams, Pharm.D. Clinical Associate Professor, OHSU/OSU School of Pharmacy
ClinicalTrials.gov Identifier: NCT00736463     History of Changes
Other Study ID Numbers: IRB00004506
Study First Received: August 14, 2008
Last Updated: July 20, 2011
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

Additional relevant MeSH terms:
Atorvastatin
Simvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014