drugset / Trial / NCT00680017
30 Week Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy for Subjects With Dyslipidemia and Stage 3 Chronic Kidney Disease
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2008-06
- Primary completion
- 2011-04
- Completion
- 2011-04
Publications
- Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.
- Weinstein DL, Williams LA, Carlson DM, Kelly MT, Burns KM, Setze CM, Lele A, Stolzenbach JC. A randomized, double-blind study of fenofibric acid plus rosuvastatin compared with rosuvastatin alone in stage 3 chronic kidney disease. Clin Ther. 2013 Aug;35(8):1186-98. doi: 10.1016/j.clinthera.2013.06.013. Epub 2013 Jul 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ABT-335 | Small molecule | 45 mg | — |
| Comparator | Rosuvastatin | Small molecule | 5 mg | — |
| Comparator | Rosuvastatin | Small molecule | 10 mg | — |