Phase 3
Completed N=280
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
Source: ClinicalTrials.gov NCT00680017 ↗Enrolled (actual)
280
Serious AEs
7.1%
Results posted
Jul 2012
Primary outcomePrimary: Median Percent Change in Triglycerides From Baseline to Week 8. — -38.0; -22.4 percent change — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Percent Change in Triglycerides From Baseline to Week 8. |
-38.0; -22.4 | <0.001 sig |
| SECONDARY Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8. |
16.9; 7.8 | <0.001 sig |
Eligibility Criteria
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]):
- Estimated glomerular filtration rate between 30 and 59 mL/min/1.73 m2 (Chronic Kidney Disease Stage 3) by simplified 4 variable Modification of Diet in Renal Disease formula (this includes a 10 percent variation in the upper limit of estimated glomerular filtration rate that was allowed for the enrollment of participants to account for variability in the creatinine assay).
- Fasting lipid results following greater than or equal to 12-hour fasting period:
- 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).
Data sourced from ClinicalTrials.gov (NCT00680017). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.