A 30-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy in Dyslipidemic Subjects With Stage 3 Chronic Kidney Disease
A 30-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy in Dyslipidemic Subjects With Stage 3 Chronic Kidney Disease
The objective of this study is to evaluate the safety and efficacy of the combination of ABT-335 plus rosuvastatin in dyslipidemic subjects with Chronic Kidney Disease (CKD) Stage 3.
Inclusion Criteria
Dyslipidemic participants with Chronic Kidney Disease Stage 3
For entry into the Treatment Phase (Visit 3), the participant satisfied the following laboratory criteria (measured at the Screening Visit[s]):
Triglycerides level greater than or equal to 150 mg/dL,
High-density lipoprotein cholesterol less than 40 mg/dL for males and less than 50 mg/dL for females, and
Low-density lipoprotein cholesterol greater than or equal to 130 mg/dL Exclusion Criteria
Participants with certain chronic or unstable medical conditions.
Participants with unstable dose of medications or receiving coumarin anticoagulants, systemic cyclosporine, or certain other medications.
Pregnant or lactating women, or women intending to become pregnant.
Participants with diabetes mellitus that is poorly controlled.
Participants of Asian ancestry (having Filipino, Chinese, Japanese, Korean, Vietnamese, or Asian-Indian origin).