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

NCT00680017 ↗

Phase 3 Completed 280 enrolled AstraZeneca
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

Outcome

Met primary endpoint

registry ABT-335 Plus Rosuvastatin vs Rosuvastatin; p <0.001; Wilcoxon rank-sum test NCT00680017 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject ABT-335 Small molecule 45 mg —
Comparator Rosuvastatin Small molecule 5 mg —
Comparator Rosuvastatin Small molecule 10 mg —