NCT00680017
Completed
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- ABT-335 plus rosuvastatin
- Conditions
- Dyslipidemia
- Sponsor
- AstraZeneca
- Enrollment
- 280
- Locations
- 114
- Primary Endpoint
- Median Percent Change in Triglycerides From Baseline to Week 8.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ABT-335 plus rosuvastatin
ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
Intervention: ABT-335 plus rosuvastatin
Rosuvastatin
Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
Intervention: Rosuvastatin
Outcomes
Primary Outcomes
Median Percent Change in Triglycerides From Baseline to Week 8.
Time Frame: Baseline to 8 weeks
Triglycerides were measured in milligrams/deciliter.
Secondary Outcomes
- Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8.(Baseline to 8 weeks)
Study Sites (114)
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