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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

Primary Purpose

Dyslipidemia, Kidney Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ABT-335 plus rosuvastatin
Rosuvastatin
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring Dyslipidemia, Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Site Reference ID/Investigator# 22521
  • Site Reference ID/Investigator# 22478
  • Site Reference ID/Investigator# 8365
  • Site Reference ID/Investigator# 8416
  • Site Reference ID/Investigator# 7869
  • Site Reference ID/Investigator# 8435
  • Site Reference ID/Investigator# 22487
  • Site Reference ID/Investigator# 22426
  • Site Reference ID/Investigator# 8096
  • Site Reference ID/Investigator# 22962
  • Site Reference ID/Investigator# 8311
  • Site Reference ID/Investigator# 22816
  • Site Reference ID/Investigator# 8510
  • Site Reference ID/Investigator# 22821
  • Site Reference ID/Investigator# 7958
  • Site Reference ID/Investigator# 15881
  • Site Reference ID/Investigator# 8399
  • Site Reference ID/Investigator# 23224
  • Site Reference ID/Investigator# 22474
  • Site Reference ID/Investigator# 21803
  • Site Reference ID/Investigator# 22811
  • Site Reference ID/Investigator# 27103
  • Site Reference ID/Investigator# 8398
  • Site Reference ID/Investigator# 26723
  • Site Reference ID/Investigator# 37676
  • Site Reference ID/Investigator# 8231
  • Site Reference ID/Investigator# 22486
  • Site Reference ID/Investigator# 22520
  • Site Reference ID/Investigator# 8226
  • Site Reference ID/Investigator# 22477
  • Site Reference ID/Investigator# 8386
  • Site Reference ID/Investigator# 22518
  • Site Reference ID/Investigator# 12882
  • Site Reference ID/Investigator# 37675
  • Site Reference ID/Investigator# 8410
  • Site Reference ID/Investigator# 21802
  • Site Reference ID/Investigator# 8136
  • Site Reference ID/Investigator# 23503
  • Site Reference ID/Investigator# 7948
  • Site Reference ID/Investigator# 22819
  • Site Reference ID/Investigator# 22813
  • Site Reference ID/Investigator# 27682
  • Site Reference ID/Investigator# 8227
  • Site Reference ID/Investigator# 13922
  • Site Reference ID/Investigator# 8094
  • Site Reference ID/Investigator# 22430
  • Site Reference ID/Investigator# 8093
  • Site Reference ID/Investigator# 38405
  • Site Reference ID/Investigator# 8903
  • Site Reference ID/Investigator# 21805
  • Site Reference ID/Investigator# 8092
  • Site Reference ID/Investigator# 8225
  • Site Reference ID/Investigator# 8407
  • Site Reference ID/Investigator# 8415
  • Site Reference ID/Investigator# 22222
  • Site Reference ID/Investigator# 8408
  • Site Reference ID/Investigator# 22703
  • Site Reference ID/Investigator# 22707
  • Site Reference ID/Investigator# 22702
  • Site Reference ID/Investigator# 8387
  • Site Reference ID/Investigator# 8177
  • Site Reference ID/Investigator# 8146
  • Site Reference ID/Investigator# 22427
  • Site Reference ID/Investigator# 22481
  • Site Reference ID/Investigator# 22708
  • Site Reference ID/Investigator# 8434
  • Site Reference ID/Investigator# 8417
  • Site Reference ID/Investigator# 8147
  • Site Reference ID/Investigator# 22488
  • Site Reference ID/Investigator# 22479
  • Site Reference ID/Investigator# 23225
  • Site Reference ID/Investigator# 22482
  • Site Reference ID/Investigator# 8345
  • Site Reference ID/Investigator# 22704
  • Site Reference ID/Investigator# 8400
  • Site Reference ID/Investigator# 8411
  • Site Reference ID/Investigator# 8405
  • Site Reference ID/Investigator# 22387
  • Site Reference ID/Investigator# 22815
  • Site Reference ID/Investigator# 12881
  • Site Reference ID/Investigator# 22706
  • Site Reference ID/Investigator# 8095
  • Site Reference ID/Investigator# 22705
  • Site Reference ID/Investigator# 22817
  • Site Reference ID/Investigator# 8098
  • Site Reference ID/Investigator# 22823
  • Site Reference ID/Investigator# 8364
  • Site Reference ID/Investigator# 22429
  • Site Reference ID/Investigator# 22428
  • Site Reference ID/Investigator# 25302
  • Site Reference ID/Investigator# 22812
  • Site Reference ID/Investigator# 8536
  • Site Reference ID/Investigator# 22810
  • Site Reference ID/Investigator# 24742
  • Site Reference ID/Investigator# 26722
  • Site Reference ID/Investigator# 8406
  • Site Reference ID/Investigator# 8232
  • Site Reference ID/Investigator# 22480
  • Site Reference ID/Investigator# 8397
  • Site Reference ID/Investigator# 21804
  • Site Reference ID/Investigator# 22423
  • Site Reference ID/Investigator# 8413
  • Site Reference ID/Investigator# 24402
  • Site Reference ID/Investigator# 22545
  • Site Reference ID/Investigator# 8301
  • Site Reference ID/Investigator# 8299
  • Site Reference ID/Investigator# 8418
  • Site Reference ID/Investigator# 8419
  • Site Reference ID/Investigator# 8421
  • Site Reference ID/Investigator# 8300
  • Site Reference ID/Investigator# 8422
  • Site Reference ID/Investigator# 8423
  • Site Reference ID/Investigator# 8420
  • Site Reference ID/Investigator# 8298

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ABT-335 plus rosuvastatin

Rosuvastatin

Arm Description

ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks

Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 15, 2008
Last Updated
September 27, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00680017
Brief Title
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
Official Title
A 30-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy in Dyslipidemic Subjects With Stage 3 Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia, Kidney Disease
Keywords
Dyslipidemia, Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABT-335 plus rosuvastatin
Arm Type
Experimental
Arm Description
ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
Arm Title
Rosuvastatin
Arm Type
Active Comparator
Arm Description
Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
Intervention Type
Drug
Intervention Name(s)
ABT-335 plus rosuvastatin
Other Intervention Name(s)
fenofibric acid and rosuvastatin
Intervention Description
ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
rosuvastatin, Crestor
Intervention Description
Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
Primary Outcome Measure Information:
Title
Median Percent Change in Triglycerides From Baseline to Week 8.
Description
Triglycerides were measured in milligrams/deciliter.
Time Frame
Baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8.
Description
High-density lipoprotein cholesterol (HDL-C) was measured in milligrams/deciliter (mg/dL).
Time Frame
Baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torbjörn Lundström, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 22521
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
Site Reference ID/Investigator# 22478
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Site Reference ID/Investigator# 8365
City
Madison
State/Province
Alabama
ZIP/Postal Code
35758
Country
United States
Facility Name
Site Reference ID/Investigator# 8416
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106-1111
Country
United States
Facility Name
Site Reference ID/Investigator# 7869
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Site Reference ID/Investigator# 8435
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Site Reference ID/Investigator# 22487
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
Site Reference ID/Investigator# 22426
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Site Reference ID/Investigator# 8096
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Site Reference ID/Investigator# 22962
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Site Reference ID/Investigator# 8311
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
Site Reference ID/Investigator# 22816
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Site Reference ID/Investigator# 8510
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
Site Reference ID/Investigator# 22821
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
Site Reference ID/Investigator# 7958
City
Arvada
State/Province
Colorado
ZIP/Postal Code
80002
Country
United States
Facility Name
Site Reference ID/Investigator# 15881
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Site Reference ID/Investigator# 8399
City
Westminster
State/Province
Colorado
ZIP/Postal Code
80031
Country
United States
Facility Name
Site Reference ID/Investigator# 23224
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Site Reference ID/Investigator# 22474
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Site Reference ID/Investigator# 21803
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33065
Country
United States
Facility Name
Site Reference ID/Investigator# 22811
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Site Reference ID/Investigator# 27103
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Site Reference ID/Investigator# 8398
City
Hudson
State/Province
Florida
ZIP/Postal Code
34667
Country
United States
Facility Name
Site Reference ID/Investigator# 26723
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Site Reference ID/Investigator# 37676
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34759
Country
United States
Facility Name
Site Reference ID/Investigator# 8231
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33313
Country
United States
Facility Name
Site Reference ID/Investigator# 22486
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Site Reference ID/Investigator# 22520
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Site Reference ID/Investigator# 8226
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Site Reference ID/Investigator# 22477
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Site Reference ID/Investigator# 8386
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Site Reference ID/Investigator# 22518
City
Plant City
State/Province
Florida
ZIP/Postal Code
33563
Country
United States
Facility Name
Site Reference ID/Investigator# 12882
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Site Reference ID/Investigator# 37675
City
St. Cloud
State/Province
Florida
ZIP/Postal Code
34769
Country
United States
Facility Name
Site Reference ID/Investigator# 8410
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Site Reference ID/Investigator# 21802
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Site Reference ID/Investigator# 8136
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Site Reference ID/Investigator# 23503
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Site Reference ID/Investigator# 7948
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Site Reference ID/Investigator# 22819
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Site Reference ID/Investigator# 22813
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
Site Reference ID/Investigator# 27682
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Site Reference ID/Investigator# 8227
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Site Reference ID/Investigator# 13922
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46545-3519
Country
United States
Facility Name
Site Reference ID/Investigator# 8094
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51501
Country
United States
Facility Name
Site Reference ID/Investigator# 22430
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Site Reference ID/Investigator# 8093
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Site Reference ID/Investigator# 38405
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Site Reference ID/Investigator# 8903
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Site Reference ID/Investigator# 21805
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Site Reference ID/Investigator# 8092
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Site Reference ID/Investigator# 8225
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Site Reference ID/Investigator# 8407
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Site Reference ID/Investigator# 8415
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Site Reference ID/Investigator# 22222
City
Brooklyn Center
State/Province
Minnesota
ZIP/Postal Code
55430
Country
United States
Facility Name
Site Reference ID/Investigator# 8408
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Site Reference ID/Investigator# 22703
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Site Reference ID/Investigator# 22707
City
Elizabeth
State/Province
New Jersey
ZIP/Postal Code
07202
Country
United States
Facility Name
Site Reference ID/Investigator# 22702
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
Site Reference ID/Investigator# 8387
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Site Reference ID/Investigator# 8177
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Site Reference ID/Investigator# 8146
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Site Reference ID/Investigator# 22427
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Site Reference ID/Investigator# 22481
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28262
Country
United States
Facility Name
Site Reference ID/Investigator# 22708
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Site Reference ID/Investigator# 8434
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Site Reference ID/Investigator# 8417
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0585
Country
United States
Facility Name
Site Reference ID/Investigator# 8147
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Site Reference ID/Investigator# 22488
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Site Reference ID/Investigator# 22479
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Site Reference ID/Investigator# 23225
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Site Reference ID/Investigator# 22482
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Site Reference ID/Investigator# 8345
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Site Reference ID/Investigator# 22704
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Site Reference ID/Investigator# 8400
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Site Reference ID/Investigator# 8411
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Site Reference ID/Investigator# 8405
City
Carlisle
State/Province
Pennsylvania
ZIP/Postal Code
17015
Country
United States
Facility Name
Site Reference ID/Investigator# 22387
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Site Reference ID/Investigator# 22815
City
Jersey Shore
State/Province
Pennsylvania
ZIP/Postal Code
17740
Country
United States
Facility Name
Site Reference ID/Investigator# 12881
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15905
Country
United States
Facility Name
Site Reference ID/Investigator# 22706
City
Perkasie
State/Province
Pennsylvania
ZIP/Postal Code
18944
Country
United States
Facility Name
Site Reference ID/Investigator# 8095
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Site Reference ID/Investigator# 22705
City
Tipton
State/Province
Pennsylvania
ZIP/Postal Code
16684
Country
United States
Facility Name
Site Reference ID/Investigator# 22817
City
Warminster
State/Province
Pennsylvania
ZIP/Postal Code
18974
Country
United States
Facility Name
Site Reference ID/Investigator# 8098
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Facility Name
Site Reference ID/Investigator# 22823
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Facility Name
Site Reference ID/Investigator# 8364
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29206
Country
United States
Facility Name
Site Reference ID/Investigator# 22429
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Site Reference ID/Investigator# 22428
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Site Reference ID/Investigator# 25302
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Site Reference ID/Investigator# 22812
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
Site Reference ID/Investigator# 8536
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
Site Reference ID/Investigator# 22810
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Site Reference ID/Investigator# 24742
City
Houston
State/Province
Texas
ZIP/Postal Code
77005
Country
United States
Facility Name
Site Reference ID/Investigator# 26722
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Site Reference ID/Investigator# 8406
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Site Reference ID/Investigator# 8232
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Site Reference ID/Investigator# 22480
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78224
Country
United States
Facility Name
Site Reference ID/Investigator# 8397
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site Reference ID/Investigator# 21804
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Site Reference ID/Investigator# 22423
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Site Reference ID/Investigator# 8413
City
Gig Harbor
State/Province
Washington
ZIP/Postal Code
98335
Country
United States
Facility Name
Site Reference ID/Investigator# 24402
City
Carolina
ZIP/Postal Code
00983
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 22545
City
Humacao
ZIP/Postal Code
00791
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 8301
City
Manati
ZIP/Postal Code
00674
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 8299
City
Ponce
ZIP/Postal Code
00717-0634
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 8418
City
Ponce
ZIP/Postal Code
00717-1322
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 8419
City
Ponce
ZIP/Postal Code
00717-2075
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 8421
City
San Juan
ZIP/Postal Code
00907
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 8300
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 8422
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 8423
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 8420
City
Toa Baja
ZIP/Postal Code
00949
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 8298
City
Yabucoa
ZIP/Postal Code
00767
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
23891363
Citation
Weinstein DL, Williams LA, Carlson DM, Kelly MT, Burns KM, Setze CM, Lele A, Stolzenbach JC. A randomized, double-blind study of fenofibric acid plus rosuvastatin compared with rosuvastatin alone in stage 3 chronic kidney disease. Clin Ther. 2013 Aug;35(8):1186-98. doi: 10.1016/j.clinthera.2013.06.013. Epub 2013 Jul 26. Erratum In: Clin Ther. 2013 Nov;35(11):1862.
Results Reference
derived

Learn more about this trial

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

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