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

September 27, 2012 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: 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
Other Names:
  • fenofibric acid and rosuvastatin
Active Comparator: Rosuvastatin
Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
Drug: Rosuvastatin
Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
Other Names:
  • rosuvastatin, Crestor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Percent Change in Triglycerides From Baseline to Week 8.
Time Frame: Baseline to 8 weeks
Triglycerides were measured in milligrams/deciliter.
Baseline to 8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Torbjörn Lundström, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

May 15, 2008

First Submitted That Met QC Criteria

May 15, 2008

First Posted (Estimate)

May 19, 2008

Study Record Updates

Last Update Posted (Estimate)

October 3, 2012

Last Update Submitted That Met QC Criteria

September 27, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-313

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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