Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides

Summary

The primary purpose of this study is to test the effect and safety of three different doses of ABT-143 compared to simvastatin in subjects with elevated levels of low density lipoprotein cholesterol ("bad cholesterol") and triglycerides.

Timeline

Start

2008-11

Primary completion

2009-06

Completion

2009-06

Outcome

Met primary endpoint

paper Significantly greater reductions in LDL-C levels from baseline values were observed with the combination of rosuvastatin/fenofibric acid 20 mg/135 mg (-47.2%, p < 0.001) PMID 20524719 ↗

paper than with simvastatin 40 mg (-32.8%). PMID 20524719 ↗

Publications

• Roth EM, McKenney JM, Kelly MT, Setze CM, Carlson DM, Gold A, Stolzenbach JC, Williams LA, Jones PH. Efficacy and safety of rosuvastatin and fenofibric acid combination therapy versus simvastatin monotherapy in patients with hypercholesterolemia and hypertriglyceridemia: a randomized, double-blind study. Am J Cardiovasc Drugs. 2010;10(3):175-86. doi: 10.2165/11533430-000000000-00000.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rosuvastatin	Small molecule	5 mg	—
Subject	Rosuvastatin	Small molecule	10 mg	—
Subject	Rosuvastatin	Small molecule	20 mg	—
Comparator	Simvastatin	Small molecule	40 mg	—
Subject	fenofibric acid	Small molecule	135 mg	—

Indications