Status:
COMPLETED
Combined Effects of Non-statin Treatments on Apolipoprotein A-I Up-Regulation (CENTAUR): A Feasibility Study
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Abbott
Conditions:
Dyslipidemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 recommende...
Detailed Description
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 postabso...
Eligibility Criteria
Inclusion
- Men/women aged 18-80 years.
- Low HDL-C, adjusted for baseline statin use
- Not on statin: Men with HDL \<= 40 or women with HDL \<= 50 mg/dL
- On statin: Men with HDL \<= 42 or women with HDL \<= 52 mg/dL
- TG/HDL ratio \>= 3.5
- Able to understand and agree to informed consent
- Women of child-bearing age must test negative on a urine pregnancy test and agree to use reliable birth control during the study and for 1 month after last dose of study drugs. Reliable methods include oral contraceptives, a barrier method, intrauterine device, partner with vasectomy, or abstinence.
- Willing to be available for study duration and follow study procedures
Exclusion
- Subjects with following lipoprotein disorders:
- Patients on high-potency lipid-lowering regimen, defined as two or more prescription lipid-altering medications (excluding fish oils) where one is a high-dose statin (40 mg/day of rosuvastatin, 80 mg/day of other approved statins). Those on combination therapy with a lower statin dose or those taking high-dose statin monotherapy (excluding fish oils) may participate. Patients will switch to atorvastatin 10 mg and/or wash off other lipid medications to participate
- LDL \> 190 mg/dL
- TG \> 750 mg/dL or pancreatitis from triglyceridemia, regardless of current TG levels
- Dysbetalipoproteinemia (VLDL/TG \> 0.3 -AND- TG \> 200 mg/dL).
- Use of non-statin lipid therapy prior to study initiation is exclusionary if (n.b. washout of non-statins is permitted):
- Niacin \> 250 mg/ day within 6 weeks: Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, or supplemental niacin
- Fibrates within 12 weeks: fenofibrate (Antara, Lofibra, Tricor, Triglide), gemfibrozil (Lopid), or clofibrate
- Enterically active drugs within 4 weeks: colestipol, cholestyramine, colesevelam, ezetimibe, orlistat.
- Red yeast rice during the treatment phase of the study (i.e. must be switched to study statin)
- Fish oil \> 2 g/day within 4 weeks: Lovaza (née Omacor), numerous supplements
- Altered dose of a selective estrogen receptor modulator (SERM) within 4 weeks
- Intolerance to statin, fibrate, aspirin, deuterated leucine, or niacin
- Contraindications to medications, including chronic muscle disease, history of rhabdomyolysis, moderate-severe gout, severe peptic ulcer disease, bleeding disorders, and aspirin-sensitive asthma.
- Diabetics, or fasting glucose \> 110 mg/dL on two different days during screening, or use of anti-diabetic medications within 6 weeks of screening visit
- Chronic renal insufficiency, nephrotic syndrome, or current serum creatinine \> 2.5 mg/dL, or GFR \< 60 mL/min/1.73m2 by the MDRD equation.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin \> 2 X the upper limit of normal (ULN), albumin of \< 2.5 mg/dL, prothrombin time (PT) \> 1.5 X ULN, partial thromboplastin time (PTT) \> 1.5 X ULN, or current active hepatobiliary disease
- Hemoglobin (Hgb) \< 10 mg/dL
- Weight \< 110 lbs
- Use of an investigational drug within 6 weeks prior to screening visit
- Major surgery within the previous 6 weeks, or anticipated major surgery during course of study, or any history of organ transplant
- Non-skin malignancy within previous 5 years
- Drug abuse within past 3 years, or regular alcohol use \>14 drinks/week
- Women who are pregnant, plan to conceive, or breast-feed
- Any serious or unstable medical or psychological conditions that, in investigator's opinion would compromise subject safety or successful participation.
- Currently adhering to, planning to adhere to or used within 3 months prior to screening, supplements intended for weight loss or adopt diets with aggressive carbohydrate restrictions, such as but not limited to Atkins or South Beach diets.
- Currently taking Vitamin A supplements (multivitamins allowed)(washout permitted)
- Excluded concomitant medications
- Immunosuppressants within 2 months prior to screening or are likely to require such treatment during the course of the study
- Warfarin.
- Disinclination to dairy products (e.g. inviolable dietary restrictions or lactose intolerance to an 8oz glass of milk despite lactase supplementation) Lactase supplementation is allowed during the study.
- Regular consumers of grapefruit juice, or currently taking medications metabolized by CYP 3A4 (cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone)
- History of pancreatitis or gallbladder disease
- History of coronary heart disease
- History of intolerance/adverse reaction to heparin or women who have dysfunctional uterine bleeding
- Thrombocytopenia at screening
- History of intracerebral or significant GI bleed
- Subjects doing regular strenuous activity or have a CK \> 3x ULN at screening
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00728910
Start Date
June 1 2008
End Date
August 1 2009
Last Update
February 29 2016
Active Locations (1)
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1
CTRC (Clinical Translational Research Center)
Philadelphia, Pennsylvania, United States, 19104