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

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# 8095
🇺🇸
Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 22812
🇺🇸
Dallas, Texas, United States
Site Reference ID/Investigator# 8136
🇺🇸
Atlanta, Georgia, United States
Site Reference ID/Investigator# 27682
🇺🇸
Chicago, Illinois, United States
Site Reference ID/Investigator# 8147
🇺🇸
Columbus, Ohio, United States
Site Reference ID/Investigator# 26722
🇺🇸
Houston, Texas, United States
Site Reference ID/Investigator# 8406
🇺🇸
Houston, Texas, United States
Site Reference ID/Investigator# 22521
🇺🇸
Birmingham, Alabama, United States
Site Reference ID/Investigator# 22479
🇺🇸
Oklahoma City, Oklahoma, United States
Site Reference ID/Investigator# 23225
🇺🇸
Oklahoma City, Oklahoma, United States
Site Reference ID/Investigator# 8397
🇺🇸
San Antonio, Texas, United States
Site Reference ID/Investigator# 22423
🇺🇸
Salt Lake City, Utah, United States
Site Reference ID/Investigator# 8399
🇺🇸
Westminster, Colorado, 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# 8096
🇺🇸
Los Angeles, California, United States
Site Reference ID/Investigator# 22478
🇺🇸
Huntsville, Alabama, United States
Site Reference ID/Investigator# 15881
🇺🇸
Denver, Colorado, United States
Site Reference ID/Investigator# 8365
🇺🇸
Madison, Alabama, United States
Site Reference ID/Investigator# 7869
🇺🇸
Chula Vista, California, United States
Site Reference ID/Investigator# 22474
🇺🇸
Clearwater, Florida, United States
Site Reference ID/Investigator# 26723
🇺🇸
Kissimmee, 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# 22819
🇺🇸
Roswell, Georgia, United States
Site Reference ID/Investigator# 21805
🇺🇸
Auburn, Maine, United States
Site Reference ID/Investigator# 8407
🇺🇸
Springfield, Massachusetts, United States
Site Reference ID/Investigator# 22707
🇺🇸
Elizabeth, New Jersey, United States
Site Reference ID/Investigator# 8386
🇺🇸
Pembroke Pines, Florida, United States
Site Reference ID/Investigator# 38405
🇺🇸
Baton Rouge, Louisiana, United States
Site Reference ID/Investigator# 8227
🇺🇸
Peoria, Illinois, United States
Site Reference ID/Investigator# 22482
🇺🇸
Tulsa, Oklahoma, United States
Site Reference ID/Investigator# 22222
🇺🇸
Brooklyn Center, Minnesota, United States
Site Reference ID/Investigator# 23503
🇺🇸
Dunwoody, Georgia, United States
Site Reference ID/Investigator# 8415
🇺🇸
Royal Oak, Michigan, United States
Site Reference ID/Investigator# 8903
🇺🇸
Shreveport, Louisiana, United States
Site Reference ID/Investigator# 8092
🇺🇸
Rockville, Maryland, United States
Site Reference ID/Investigator# 8408
🇺🇸
Olive Branch, Mississippi, United States
Site Reference ID/Investigator# 8387
🇺🇸
Flushing, New York, United States
Site Reference ID/Investigator# 22702
🇺🇸
Hillsborough, New Jersey, United States
Site Reference ID/Investigator# 8345
🇺🇸
Bend, Oregon, United States
Site Reference ID/Investigator# 22704
🇺🇸
Medford, Oregon, United States
Site Reference ID/Investigator# 22480
🇺🇸
San Antonio, Texas, United States
Site Reference ID/Investigator# 8419
🇵🇷
Ponce, Puerto Rico
Site Reference ID/Investigator# 22706
🇺🇸
Perkasie, Pennsylvania, United States
Site Reference ID/Investigator# 8423
🇵🇷
San Juan, Puerto Rico
Site Reference ID/Investigator# 22429
🇺🇸
Greenville, South Carolina, United States
Site Reference ID/Investigator# 8413
🇺🇸
Gig Harbor, Washington, United States
Site Reference ID/Investigator# 8364
🇺🇸
Columbia, South Carolina, United States
Site Reference ID/Investigator# 24742
🇺🇸
Houston, Texas, United States
Site Reference ID/Investigator# 8301
🇵🇷
Manati, Puerto Rico
Site Reference ID/Investigator# 22428
🇺🇸
Mount Pleasant, South Carolina, United States
Site Reference ID/Investigator# 22545
🇵🇷
Humacao, Puerto Rico
Site Reference ID/Investigator# 8418
🇵🇷
Ponce, Puerto Rico
Site Reference ID/Investigator# 8299
🇵🇷
Ponce, Puerto Rico
Site Reference ID/Investigator# 8300
🇵🇷
San Juan, Puerto Rico
Site Reference ID/Investigator# 8421
🇵🇷
San Juan, Puerto Rico
Site Reference ID/Investigator# 8298
🇵🇷
Yabucoa, Puerto Rico
Site Reference ID/Investigator# 8177
🇺🇸
Great Neck, New York, United States
Site Reference ID/Investigator# 22427
🇺🇸
Williamsville, New York, United States
Site Reference ID/Investigator# 8400
🇺🇸
Portland, Oregon, United States
Site Reference ID/Investigator# 8434
🇺🇸
Morehead City, North Carolina, United States
Site Reference ID/Investigator# 8435
🇺🇸
Fountain Valley, California, United States
Site Reference ID/Investigator# 22962
🇺🇸
Norwalk, California, United States
Site Reference ID/Investigator# 8094
🇺🇸
Council Bluffs, Iowa, United States
Site Reference ID/Investigator# 27103
🇺🇸
Hollywood, Florida, United States
Site Reference ID/Investigator# 8231
🇺🇸
Lauderdale Lakes, Florida, United States
Site Reference ID/Investigator# 22486
🇺🇸
Longwood, Florida, United States
Site Reference ID/Investigator# 22520
🇺🇸
New Port Richey, Florida, United States
Site Reference ID/Investigator# 22477
🇺🇸
Ormond Beach, Florida, United States
Site Reference ID/Investigator# 8410
🇺🇸
West Palm Beach, Florida, United States
Site Reference ID/Investigator# 37675
🇺🇸
St. Cloud, Florida, United States
Site Reference ID/Investigator# 21802
🇺🇸
Winter Haven, Florida, United States
Site Reference ID/Investigator# 8536
🇺🇸
Edinburg, Texas, United States
Site Reference ID/Investigator# 22481
🇺🇸
Charlotte, North Carolina, United States
Site Reference ID/Investigator# 8098
🇺🇸
Providence, Rhode Island, United States
Site Reference ID/Investigator# 8416
🇺🇸
Montgomery, Alabama, 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# 8311
🇺🇸
Riverside, California, United States
Site Reference ID/Investigator# 37676
🇺🇸
Kissimmee, Florida, United States
Site Reference ID/Investigator# 8398
🇺🇸
Hudson, Florida, United States
Site Reference ID/Investigator# 22518
🇺🇸
Plant City, Florida, United States
Site Reference ID/Investigator# 12882
🇺🇸
Port Charlotte, Florida, United States
Site Reference ID/Investigator# 7948
🇺🇸
Macon, Georgia, United States
Site Reference ID/Investigator# 22813
🇺🇸
Suwanee, Georgia, United States
Site Reference ID/Investigator# 22430
🇺🇸
Iowa City, Iowa, United States
Site Reference ID/Investigator# 8093
🇺🇸
Paducah, Kentucky, United States
Site Reference ID/Investigator# 8225
🇺🇸
Fall River, Massachusetts, United States
Site Reference ID/Investigator# 13922
🇺🇸
Mishawaka, Indiana, United States
Site Reference ID/Investigator# 22703
🇺🇸
Berlin, New Jersey, United States
Site Reference ID/Investigator# 22708
🇺🇸
Charlotte, North Carolina, United States
Site Reference ID/Investigator# 22488
🇺🇸
Mason, Ohio, United States
Site Reference ID/Investigator# 8405
🇺🇸
Carlisle, Pennsylvania, United States
Site Reference ID/Investigator# 8146
🇺🇸
Lake Success, New York, United States
Site Reference ID/Investigator# 8417
🇺🇸
Cincinnati, Ohio, United States
Site Reference ID/Investigator# 22387
🇺🇸
Duncansville, Pennsylvania, United States
Site Reference ID/Investigator# 8411
🇺🇸
Bethlehem, Pennsylvania, United States
Site Reference ID/Investigator# 12881
🇺🇸
Johnstown, Pennsylvania, United States
Site Reference ID/Investigator# 22815
🇺🇸
Jersey Shore, Pennsylvania, United States
Site Reference ID/Investigator# 22817
🇺🇸
Warminster, Pennsylvania, United States
Site Reference ID/Investigator# 22705
🇺🇸
Tipton, Pennsylvania, United States
Site Reference ID/Investigator# 25302
🇺🇸
Summerville, South Carolina, United States
Site Reference ID/Investigator# 8232
🇺🇸
Lubbock, Texas, United States
Site Reference ID/Investigator# 24402
🇵🇷
Carolina, Puerto Rico
Site Reference ID/Investigator# 22810
🇺🇸
Fort Worth, Texas, United States
Site Reference ID/Investigator# 21804
🇺🇸
Ogden, Utah, United States
Site Reference ID/Investigator# 8422
🇵🇷
San Juan, Puerto Rico
Site Reference ID/Investigator# 8420
🇵🇷
Toa Baja, Puerto Rico
Site Reference ID/Investigator# 22816
🇺🇸
Sacramento, California, United States
Site Reference ID/Investigator# 8226
🇺🇸
Orlando, Florida, United States
Site Reference ID/Investigator# 22823
🇺🇸
Charleston, South Carolina, United States
Site Reference ID/Investigator# 23224
🇺🇸
Boynton Beach, Florida, United States
Site Reference ID/Investigator# 8510
🇺🇸
Simi Valley, California, United States