A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia

Phase 3 Completed 310 enrolled Abbott

RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of the study is to assess the continued safety of the daily coadministration of ABT-335 in combination with rosuvastatin calcium, simvastatin or atorvastatin calcium.

Timeline

Start: 2007-06
Primary completion: 2008-11
Completion: 2008-11

Publications

Kipnes MS, Roth EM, Rhyne JM, Setze CM, Lele A, Kelly MT, Sleep DJ, Stolzenbach JC. Year two assessment of fenofibric acid and moderate-dose statin combination: a phase 3, open-label, extension study. Clin Drug Investig. 2010;30(1):51-61. doi: 10.2165/11319800-000000000-00000.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ABT-335	Small molecule	135 mg	Oral
Subject	Atorvastatin	Small molecule	40 mg	Oral
Subject	Rosuvastatin	Small molecule	20 mg	Oral
Subject	Simvastatin	Small molecule	40 mg	Oral

A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia

Summary

Timeline

Publications

Drugs

Indications