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| Sponsor: | University of Pennsylvania |
|---|---|
| Collaborator: |
Abbott |
| Information provided by: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00728910 |
Purpose
The investigators propose to investigate if using a combination of medications that may improve cholesterol give additional benefit to that gained from the statin medication, Lipitor. It is recommended that patients who meet certain criteria for risk of heart disease take a statin medication to improve cholesterol and hopefully reduce risk of heart disease. The combination therapy will include Lipitor, Niaspan, and investigational medication (known as ABT335) in a class of drugs called fibrates. We are looking to see if and how these three medications together might improve risk factors for atherosclerosis and influence HDL cholesterol. The study will also look at the safety and any side effects that might be associated with this combination of medications.
| Condition | Intervention | Phase |
|---|---|---|
|
Atherogenic Dyslipidemia |
Drug: Lipitor Drug: ABT335 Drug: Niaspan |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Bio-availability Study |
| Official Title: | Combined Effects of Non-statin Treatments on Apolipoprotein A-I Up-Regulation (CENTAUR): A Feasibility Study |
| Enrollment: | 25 |
| Study Start Date: | June 2008 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Objectives Summary
* To investigate whether the progressive addition of a fibrate and niacin to baseline statin therapy will improve apolipoprotein A-I kinetics, postprandial lipidemia, and postabsorptive lipoproteins and metabolism in adult men and women with atherogenic dyslipidemia.
Major Efficacy Aims
Additional Aims
* Objective 4 is to assess tolerability and adverse events when ABT335 and ER niacin are added sequentially to atorvastatin. Specifically, we will assess changes in hepatobiliary laboratory tests (including incidence of elevation), incidence of symptomatic myalgia, and incidence of flushing. On an exploratory basis, we will enhance the flushing evaluation with objective and subjective measurements of flushing during inpatient visits.
Study Design:
This is an open-label feasibility study of fixed-sequence addition of lipid-altering medications, in which comparisons are made to the baseline for each subject. Subjects begin a lead-in phase in which they start the study statin (atorvastatin) or switch from previous statin therapy to the study statin. Subjects will wash off other excluded lipid-altering drugs during the lead-in. Subjects return for the first inpatient visit, where they have baseline studies on statin monotherapy. At the end of this visit, subjects are started on fibrate therapy (ABT335). They repeat the studies on dual therapy with statin and fibrate, and then add niacin (ER niacin). To minimize flushing during chronic treatment, they start aspirin 325 mg daily, or titrate to 325 mg if they are taking a lower dose of aspirin (e.g. 81 mg). Finally, they repeat the studies on triple therapy with statin, fibrate, and niacin/aspirin.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Low HDL cholesterol, adjusted for baseline use of statin drugs
Exclusion Criteria:
Subjects with the following lipoprotein disorders:
Use of daily non-statin lipid-altering therapy prior to the initiation of study medication is exclusionary under the following circumstances (n.b. washout of non-statins is permitted):
Excluded concomitant medications
Contacts and Locations| United States, Pennsylvania | |
| CTRC (Clinical Translational Research Center) | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Richard L Dunbar, MD | University of Pennsylvania |
More Information
| Responsible Party: | University of Pennsylvania ( Dr. Richard Dunbar ) |
| Study ID Numbers: | 807965 CNTR, CTRC #1123 |
| Study First Received: | August 4, 2008 |
| Last Updated: | December 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00728910 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Low HDL cholesterol High triglycerides |
|
Metabolic Diseases Dyslipidemias Lipid Metabolism Disorders |