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

Completed · Phase 3

Conditions studied: Dyslipidemia, Kidney Disease

In brief

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.

Key facts

Study ID

NCT00680017

Run by

AstraZeneca

People needed

280

Starts

2008-06-01

Expected to finish

2011-04-01

Last updated by the study team

2012-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

Where it is running

• Site Reference ID/Investigator# 22478 — Huntsville, Alabama, United States
• Site Reference ID/Investigator# 8365 — Madison, Alabama, United States
• Site Reference ID/Investigator# 8416 — Montgomery, Alabama, United States
• Site Reference ID/Investigator# 7869 — Chula Vista, California, United States
• Site Reference ID/Investigator# 8435 — Fountain Valley, California, United States
• Site Reference ID/Investigator# 22487 — Lincoln, California, United States
• Site Reference ID/Investigator# 22426 — Long Beach, California, United States
• Site Reference ID/Investigator# 8096 — Los Angeles, California, United States
• Site Reference ID/Investigator# 22962 — Norwalk, California, United States
• Site Reference ID/Investigator# 8311 — Riverside, California, United States
• Site Reference ID/Investigator# 22816 — Sacramento, California, United States
• Site Reference ID/Investigator# 8510 — Simi Valley, California, United States
• Site Reference ID/Investigator# 22821 — West Hills, California, United States
• Site Reference ID/Investigator# 7958 — Arvada, Colorado, United States
• Site Reference ID/Investigator# 15881 — Denver, Colorado, United States
• Site Reference ID/Investigator# 8399 — Westminster, Colorado, United States
• Site Reference ID/Investigator# 23224 — Boynton Beach, Florida, United States
• Site Reference ID/Investigator# 22474 — Clearwater, Florida, United States
• Site Reference ID/Investigator# 21803 — Coral Springs, Florida, United States
• Site Reference ID/Investigator# 22811 — Daytona Beach, Florida, United States
• Site Reference ID/Investigator# 27103 — Hollywood, Florida, United States
• Site Reference ID/Investigator# 8398 — Hudson, Florida, United States
• Site Reference ID/Investigator# 26723 — Kissimmee, Florida, United States
• Site Reference ID/Investigator# 37676 — Kissimmee, Florida, United States
• Site Reference ID/Investigator# 22521 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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