Crossover of Higher Dose Statins in Patients With Low High-density Lipoproteins Cholesterol (HDLc)
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|ClinicalTrials.gov 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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Active Comparator: 1
Aimvastatin 80 mg
One arm of randomized crossover
Active Comparator: 2
Atorvastatin 80 mg
Drug: Atorvastatin 80 mg
Second arm of randomized crossover
- HDL cholesterol [ Time Frame: 6 weeks ]
- HS-CRP, apolipoprotein A1 and B [ Time Frame: 6 weeks ]
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 ClinicalTrials.gov identifier (NCT number): NCT00736463
|Contact: Craig D Williams, PharmDemail@example.com|
|Contact: Darlene Kittermanfirstname.lastname@example.org|
|United States, Oregon|
|Portland, Oregon, United States, 97239|
|Principal Investigator: Craig D Williams, PharmD|
|Principal Investigator:||Craig D Williams||Oregon Health and Science University|