Combined Effects of Non-statin Treatments on Apolipoprotein A-I Up-Regulation (CENTAUR): A Feasibility Study
NCT00728910 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2016-02-29
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 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.
Conditions
Interventions
- DRUG
-
10 mg QD for 4 weeks
- DRUG
-
ABT335
135 mg QD added to atorvastatin for 8 weeks
- DRUG
-
ER Niacin
2000 mg QD added to atorvastatin and ABT335 for 10 weeks
Sponsors & Collaborators
- collaborator INDUSTRY
- lead OTHER
Principal Investigators
-
Richard L Dunbar, MD · University of Pennsylvania
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-06-30
- Primary Completion
- 2009-08-31
- Completion
- 2009-08-31
Countries
- United States
Study Locations
More Related Trials
-
Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet
NCT00917579 ·Status: COMPLETED ·Phase: PHASE4
-
A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects With Dyslipidemia
NCT00463606 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/20 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 20 mg Tablets in Participants With High Cholesterol (MK-0653C-185 AM1)
NCT01370590 ·Status: COMPLETED ·Phase: PHASE3
-
Effectiveness Of A Program That Includes Counseling And Patient Support On Adherence To Treatment With Lipitor
NCT01078285 ·Status: COMPLETED
-
Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients
NCT03611010 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Atorvastatin in Healthy Adult Participants (MK-0616-024)
NCT06699355 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of the Fixed-dose Combination Atorvastatin/Fenofibrate vs Atorvastatin in Patients With T2D and DLP.
NCT04882293 ·Status: UNKNOWN ·Phase: PHASE3
-
The Effect of MK0859 on Lipoprotein Metabolism in Patients With Dyslipidemia (0859-026 AM3)
NCT00990808 ·Status: COMPLETED ·Phase: PHASE1
-
A Multiple-Dose Pharmacokinetic Interaction Study Between ABT-335, Atorvastatin and Ezetimibe
NCT00681525 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood
NCT00300456 ·Status: COMPLETED ·Phase: PHASE3
-
A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia
NCT00491530 ·Status: COMPLETED ·Phase: PHASE3
-
A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin
NCT00530946 ·Status: COMPLETED ·Phase: PHASE3
-
Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550
NCT01059864 ·Status: COMPLETED ·Phase: PHASE2
-
12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia
NCT00664859 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Actual Use Trial of Atorvastatin Calcium 10 mg
NCT01964326 ·Status: COMPLETED ·Phase: PHASE3
-
A Study Of Pharmacokinetics, Pharmacodynamics And Safety Of Adding ETC-1002 To Atorvastatin 80 mg
NCT02659397 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy Study Using ABT-335 (Investigational Drug) in Combination With Atorvastatin, to Study the Effects on Thickening of the Blood Vessel Wall in Patients With Abnormal Lipid (Fat) Levels in the Blood
NCT00616772 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Atorvastatin/Fenofibrate (LCP-AtorFen) Combination Therapy in Dyslipidemia
NCT00504829 ·Status: COMPLETED ·Phase: PHASE2
-
Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets
NCT00442325 ·Status: COMPLETED ·Phase: PHASE4
-
Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis
NCT00361283 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluate Safety and Efficacy of ABT-335 in Combination With Rosuvastatin Calcium in Subjects With Multiple Abnormal Lipid Levels in the Blood
NCT00300482 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of a Fibrate and a Statin on Endothelial Dysfunction
NCT00491400 ·Status: TERMINATED ·Phase: NA
-
A Study Of SB-751689, Atorvastatin, Ketoconazole, And Rosuvastatin In Health Postmenopausal Women.
NCT00388596 ·Status: COMPLETED ·Phase: PHASE1
-
Atorvastatin Versus Ezetimibe and Fenofibrate as a Lipid-lowering Strategy
NCT00299884 ·Status: COMPLETED
-
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia
NCT01288469 ·Status: COMPLETED ·Phase: PHASE2