At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 280 enrolled
Drug / intervention
ABT-335 plus rosuvastatin +1 moredrug
Likely dose
ABT-335 plus rosuvastatin 45 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating ABT-335 plus rosuvastatin and Rosuvastatin for Dyslipidemia and Kidney Disease. Completed, enrolled 280 participants across 114 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyslipidemia, Kidney Disease
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2008
Enrollment StartJun 2008
Primary CompletionApr 2011
TodayJul 2026
First PostedMay 19, 2008
Enrollment StartJun 1, 2008
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.1 years ago
Interventions
ABT-335 plus rosuvastatindrug
ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
Rosuvastatindrug
Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks