Status:
COMPLETED
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
Lead Sponsor:
AstraZeneca
Conditions:
Dyslipidemia
Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00680017
Start Date
June 1 2008
End Date
April 1 2011
Last Update
October 3 2012
Active Locations (114)
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1
Site Reference ID/Investigator# 22521
Birmingham, Alabama, United States, 35242
2
Site Reference ID/Investigator# 22478
Huntsville, Alabama, United States, 35801
3
Site Reference ID/Investigator# 8365
Madison, Alabama, United States, 35758
4
Site Reference ID/Investigator# 8416
Montgomery, Alabama, United States, 36106-1111