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 · Type: INTERVENTIONAL · Enrollment: 657
Last updated 2009-06-03
Summary
The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + simvastatin combination therapy with ABT-335 and simvastatin monotherapy in subjects with multiple abnormal lipid levels in the blood.
Conditions
- Dyslipidemia
- Coronary Heart Disease
- Mixed Dyslipidemia
Interventions
- DRUG
-
ABT-335
135 mg, daily, 12 weeks
- DRUG
-
Simvastatin
daily, 12 weeks, see Arm Description for dosage information
- DRUG
-
Daily, 12 weeks, see Arm Description for placebo information
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-03-31
- Primary Completion
- 2007-03-31
Countries
- United States
Study Locations
More Related Trials
-
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
-
Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides
NCT00812955 ·Status: COMPLETED ·Phase: PHASE3
-
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
-
ABT-335 (Choline Fenofibrate) Reverse Cholesterol Transport (RCT) Study
NCT00673881 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease
NCT01674712 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)
NCT00535405 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of the Combination of Fenofibrate and 40 mg Simvastatin Versus 40 mg Simvastatin Monotherapy
NCT00352183 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg, Ezetimibe 10mg, and Atorvastatin 20 mg Triplet Therapy in Patients With Elevated LDL-C
NCT03051100 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant
NCT02988115 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy
NCT00349375 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin
NCT00362934 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Pharmacokinetics and Pharmacodynamics of LGT209 in Healthy Volunteers With Elevated Cholesterol and in Hypercholesterolemic Patients Treated With Statins
NCT01859455 ·Status: COMPLETED ·Phase: PHASE1
-
A Confirmatory Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia
NCT05683340 ·Status: COMPLETED ·Phase: PHASE3
-
A Multiple-Dose Pharmacokinetic Interaction Study Between ABT-335, Atorvastatin and Ezetimibe
NCT00681525 ·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
-
A Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin in Subjects With Hypercholesterolemia
NCT01779453 ·Status: COMPLETED ·Phase: PHASE2
-
Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody
NCT02189837 ·Status: COMPLETED ·Phase: PHASE3
-
Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)
NCT00653835 ·Status: COMPLETED ·Phase: PHASE4
-
Randomized Study of Obicetrapib in Combination With Ezetimibe
NCT04770389 ·Status: COMPLETED ·Phase: PHASE2
-
Atorvastatin Versus Simvastatin In The Prevention Of Coronary Heart Disease (CHD) In Patients With Known CHD
NCT00159835 ·Status: COMPLETED ·Phase: PHASE4
-
A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin
NCT00530946 ·Status: COMPLETED ·Phase: PHASE3
-
Ezetimibe and Simvastatin in Primary Hypercholesterolemia, Diabetes Mellitus Type 2, and Coronary Heart Disease (COMPLETED)
NCT00423488 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy And Safety Study Of Atorvastatin Versus Simvastatin In Type 2 Diabetic Subjects With Hypercholesterolemia
NCT00141141 ·Status: COMPLETED ·Phase: PHASE4
-
Ezetimibe (SCH 58235) Taken With Either Atorvastatin or Simvastatin in Participants With Familial Hypercholesterolemia (MK-0653-018)
NCT03884452 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Ezetimibe or Simvastatin or Both on Low Densitiy Lipoprotein -Subfractions in Patients With Type 2 Diabetes
NCT01384058 ·Status: COMPLETED ·Phase: PHASE4