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

Phase 3

Completed

• Conditions: Dyslipidemia; Kidney Disease
• Interventions: Drug: ABT-335 plus rosuvastatin; Drug: Rosuvastatin

• Registration Number: NCT00680017
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-15
• Study First Submitted QC: 2008-05-15
• Study First Posted: 2008-05-19
• Study Start: 2008-06
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Disposition First Submitted: 2011-09-26
• Disposition First Submitted QC: 2011-09-26
• Disposition First Posted: 2011-10-05
• Results First Submitted: 2012-04-25
• Results First Submitted QC: 2012-06-13
• Results First Posted: 2012-07-16
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-27
• Last Update Posted: 2012-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABT-335 plus rosuvastatin	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
Rosuvastatin	Rosuvastatin	Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks

Primary Outcome Measures

Name	Time	Method
Median Percent Change in Triglycerides From Baseline to Week 8.	Baseline to 8 weeks	Triglycerides were measured in milligrams/deciliter.

Secondary Outcome Measures

Name	Time	Method
Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8.	Baseline to 8 weeks	High-density lipoprotein cholesterol (HDL-C) was measured in milligrams/deciliter (mg/dL).

Trial Locations

Locations (114)

Site Reference ID/Investigator# 22521; 🇺🇸 Birmingham, Alabama, United States

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

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