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A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects With Dyslipidemia

Primary Purpose

Hypercholesterolemia, Dyslipidemia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ABT-335 and rosuvastatin calcium
ABT-335
rosuvastatin calcium
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

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

Inclusion Criteria

  • Adult male and female participants who voluntarily sign the informed consent.

  • Fasting lipid results following greater than 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.
  • Participant must agree to utilize adequate birth control methods and adhere to the American Heart Association (AHA) diet.

Exclusion Criteria

  • Participants with unstable medical conditions, medical conditions considered inappropriate in a clinical trial, or participants who are taking excluded concomitant medications are not allowed in the study.
  • Participants receiving coumarin anticoagulants or systemic cyclosporine.

Sites / Locations

  • Site Reference ID/Investigator# 5469
  • Site Reference ID/Investigator# 4428
  • Site Reference ID/Investigator# 4985
  • Site Reference ID/Investigator# 4493
  • Site Reference ID/Investigator# 4510
  • Site Reference ID/Investigator# 4431
  • Site Reference ID/Investigator# 4519
  • Site Reference ID/Investigator# 4395
  • Site Reference ID/Investigator# 4483
  • Site Reference ID/Investigator# 4411
  • Site Reference ID/Investigator# 4417
  • Site Reference ID/Investigator# 4702
  • Site Reference ID/Investigator# 5593
  • Site Reference ID/Investigator# 4503
  • Site Reference ID/Investigator# 4530
  • Site Reference ID/Investigator# 4458
  • Site Reference ID/Investigator# 4542
  • Site Reference ID/Investigator# 4574
  • Site Reference ID/Investigator# 4441
  • Site Reference ID/Investigator# 4432
  • Site Reference ID/Investigator# 5579
  • Site Reference ID/Investigator# 4980
  • Site Reference ID/Investigator# 4392
  • Site Reference ID/Investigator# 4896
  • Site Reference ID/Investigator# 5582
  • Site Reference ID/Investigator# 6236
  • Site Reference ID/Investigator# 4442
  • Site Reference ID/Investigator# 4419
  • Site Reference ID/Investigator# 4391
  • Site Reference ID/Investigator# 4401
  • Site Reference ID/Investigator# 4453
  • Site Reference ID/Investigator# 4490
  • Site Reference ID/Investigator# 4420
  • Site Reference ID/Investigator# 5011
  • Site Reference ID/Investigator# 4444
  • Site Reference ID/Investigator# 4399
  • Site Reference ID/Investigator# 4433
  • Site Reference ID/Investigator# 4469
  • Site Reference ID/Investigator# 4525
  • Site Reference ID/Investigator# 4477
  • Site Reference ID/Investigator# 4430
  • Site Reference ID/Investigator# 4409
  • Site Reference ID/Investigator# 4416
  • Site Reference ID/Investigator# 4528
  • Site Reference ID/Investigator# 5103
  • Site Reference ID/Investigator# 4446
  • Site Reference ID/Investigator# 4524
  • Site Reference ID/Investigator# 4505
  • Site Reference ID/Investigator# 5580
  • Site Reference ID/Investigator# 4494
  • Site Reference ID/Investigator# 4407
  • Site Reference ID/Investigator# 4512
  • Site Reference ID/Investigator# 5478
  • Site Reference ID/Investigator# 4388
  • Site Reference ID/Investigator# 4511
  • Site Reference ID/Investigator# 4981
  • Site Reference ID/Investigator# 4448
  • Site Reference ID/Investigator# 4497
  • Site Reference ID/Investigator# 4439
  • Site Reference ID/Investigator# 4472
  • Site Reference ID/Investigator# 5585
  • Site Reference ID/Investigator# 4520
  • Site Reference ID/Investigator# 4527
  • Site Reference ID/Investigator# 4485
  • Site Reference ID/Investigator# 4445
  • Site Reference ID/Investigator# 4438
  • Site Reference ID/Investigator# 5010
  • Site Reference ID/Investigator# 4403
  • Site Reference ID/Investigator# 4393
  • Site Reference ID/Investigator# 4526
  • Site Reference ID/Investigator# 4423
  • Site Reference ID/Investigator# 4424
  • Site Reference ID/Investigator# 5027
  • Site Reference ID/Investigator# 4471
  • Site Reference ID/Investigator# 4406
  • Site Reference ID/Investigator# 4509
  • Site Reference ID/Investigator# 5635
  • Site Reference ID/Investigator# 4502
  • Site Reference ID/Investigator# 5070
  • Site Reference ID/Investigator# 4412
  • Site Reference ID/Investigator# 4487
  • Site Reference ID/Investigator# 5533
  • Site Reference ID/Investigator# 6237
  • Site Reference ID/Investigator# 5583
  • Site Reference ID/Investigator# 4480
  • Site Reference ID/Investigator# 4515
  • Site Reference ID/Investigator# 4492
  • Site Reference ID/Investigator# 5636
  • Site Reference ID/Investigator# 4500
  • Site Reference ID/Investigator# 4499
  • Site Reference ID/Investigator# 4979
  • Site Reference ID/Investigator# 4481
  • Site Reference ID/Investigator# 4460
  • Site Reference ID/Investigator# 4466
  • Site Reference ID/Investigator# 5484
  • Site Reference ID/Investigator# 5444
  • Site Reference ID/Investigator# 4908
  • Site Reference ID/Investigator# 4504
  • Site Reference ID/Investigator# 4394
  • Site Reference ID/Investigator# 4402
  • Site Reference ID/Investigator# 4427
  • Site Reference ID/Investigator# 4463
  • Site Reference ID/Investigator# 4415
  • Site Reference ID/Investigator# 4440
  • Site Reference ID/Investigator# 4464
  • Site Reference ID/Investigator# 4425
  • Site Reference ID/Investigator# 4473
  • Site Reference ID/Investigator# 4531
  • Site Reference ID/Investigator# 4396
  • Site Reference ID/Investigator# 5494
  • Site Reference ID/Investigator# 4479
  • Site Reference ID/Investigator# 4461
  • Site Reference ID/Investigator# 4498
  • Site Reference ID/Investigator# 4405
  • Site Reference ID/Investigator# 4476
  • Site Reference ID/Investigator# 4390
  • Site Reference ID/Investigator# 4400
  • Site Reference ID/Investigator# 4501
  • Site Reference ID/Investigator# 4517
  • Site Reference ID/Investigator# 5584
  • Site Reference ID/Investigator# 4410
  • Site Reference ID/Investigator# 4443
  • Site Reference ID/Investigator# 4523
  • Site Reference ID/Investigator# 4488
  • Site Reference ID/Investigator# 4451
  • Site Reference ID/Investigator# 4422
  • Site Reference ID/Investigator# 4482
  • Site Reference ID/Investigator# 4467
  • Site Reference ID/Investigator# 4470
  • Site Reference ID/Investigator# 5581
  • Site Reference ID/Investigator# 4434
  • Site Reference ID/Investigator# 4478
  • Site Reference ID/Investigator# 4436
  • Site Reference ID/Investigator# 4397
  • Site Reference ID/Investigator# 4426
  • Site Reference ID/Investigator# 4894
  • Site Reference ID/Investigator# 4496
  • Site Reference ID/Investigator# 4404
  • Site Reference ID/Investigator# 4437
  • Site Reference ID/Investigator# 4387
  • Site Reference ID/Investigator# 4447
  • Site Reference ID/Investigator# 4506
  • Site Reference ID/Investigator# 5443
  • Site Reference ID/Investigator# 4484
  • Site Reference ID/Investigator# 4455
  • Site Reference ID/Investigator# 4513
  • Site Reference ID/Investigator# 4521
  • Site Reference ID/Investigator# 4982
  • Site Reference ID/Investigator# 5586
  • Site Reference ID/Investigator# 4435
  • Site Reference ID/Investigator# 4454
  • Site Reference ID/Investigator# 4529
  • Site Reference ID/Investigator# 5454
  • Site Reference ID/Investigator# 5578
  • Site Reference ID/Investigator# 5669
  • Site Reference ID/Investigator# 4893
  • Site Reference ID/Investigator# 4429
  • Site Reference ID/Investigator# 4457
  • Site Reference ID/Investigator# 4465
  • Site Reference ID/Investigator# 4508
  • Site Reference ID/Investigator# 4892
  • Site Reference ID/Investigator# 5948
  • Site Reference ID/Investigator# 4413
  • Site Reference ID/Investigator# 4456
  • Site Reference ID/Investigator# 4459
  • Site Reference ID/Investigator# 4408
  • Site Reference ID/Investigator# 4421
  • Site Reference ID/Investigator# 4468

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

ABT-335 and Rosuvastatin Calcium

ABT-335

Rosuvastatin Calcium

Arm Description

ABT-335 135mg in combination with rosuvastatin calcium 5mg administered orally, once daily for 12 weeks

ABT-335 135mg monotherapy administered orally, once daily for 12 weeks

Rosuvastatin calcium 5mg monotherapy administered orally, once daily for 12 weeks

Outcomes

Primary Outcome Measures

Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set)
The mean percent change from baseline to the final visit in High-density lipoprotein cholesterol (HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set)
The mean percent change from baseline to the final visit in triglycerides, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set)
The mean percent change from baseline to the final visit in low-density lipoprotein cholesterol (LDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.

Secondary Outcome Measures

Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus ABT-335 135 mg Monotherapy (Full Analysis Set)
The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.
Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus Rosuvastatin 5 mg Monotherapy (Full Analysis Set)
The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Mean Percent Change From Baseline to the Final Visit in Very-low-density Lipoprotein Cholesterol (VLDL-C) (Full Analysis Set)
The mean percent change from baseline to the final visit in very-low-density lipoprotein cholesterol (VLDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Mean Percent Change From Baseline to the Final Visit in Apolipoprotein B (ApoB) (Full Analysis Set)
The mean percent change from baseline to the final visit in apolipoprotein B (ApoB), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Median Percent Change From Baseline to the Final Visit in High Sensitivity C-reactive Protein (hsCRP) (Full Analysis Set)
The median percent change from baseline to the final visit in high sensitivity C-reactive protein (hsCRP), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Mean Percent Change From Baseline to the Final Visit in Total Cholesterol (Full Analysis Set)
The mean percent change from baseline to the final visit in total cholesterol, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.

Full Information

First Posted
April 19, 2007
Last Updated
September 27, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00463606
Brief Title
A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects With Dyslipidemia
Official Title
A 12-week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to ABT-335 and Rosuvastatin Monotherapy in Subjects With Type IIa and IIb Dyslipidemia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and efficacy of ABT-335 and rosuvastatin calcium combination therapy to monotherapy in subjects with dyslipidemia.
Detailed Description
There are 3 treatment groups in the study: ABT-335 135 mg in combination with rosuvastatin 5 mg, ABT-335 135 mg monotherapy, and rosuvastatin 5 mg monotherapy. The 3 primary outcome measures only compare 2 of the treatment groups for each variable (mean percent change in HDL-C and TG comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy, and mean percent change in LDL-C comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to ABT-335 135 mg monotherapy. The 6 secondary outcome measures only compare 2 of the treatment groups for each variable (mean percent change in Non-HDL-C comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to ABT-335 135 mg monotherapy, mean percent change in Non-HDL-C, VLDL-C, ApoB, and Total Cholesterol comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy, and median percent change in hsCRP comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
760 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABT-335 and Rosuvastatin Calcium
Arm Type
Experimental
Arm Description
ABT-335 135mg in combination with rosuvastatin calcium 5mg administered orally, once daily for 12 weeks
Arm Title
ABT-335
Arm Type
Active Comparator
Arm Description
ABT-335 135mg monotherapy administered orally, once daily for 12 weeks
Arm Title
Rosuvastatin Calcium
Arm Type
Active Comparator
Arm Description
Rosuvastatin calcium 5mg monotherapy administered orally, once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
ABT-335 and rosuvastatin calcium
Other Intervention Name(s)
ABT-335 / Rosuvastatin Combination (ABT-143)
Intervention Description
ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
ABT-335
Other Intervention Name(s)
fenofibric acid
Intervention Description
ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
rosuvastatin calcium
Other Intervention Name(s)
Rosuvastatin
Intervention Description
Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Primary Outcome Measure Information:
Title
Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set)
Description
The mean percent change from baseline to the final visit in High-density lipoprotein cholesterol (HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Time Frame
Baseline to 12 Weeks
Title
Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set)
Description
The mean percent change from baseline to the final visit in triglycerides, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Time Frame
Baseline to 12 Weeks
Title
Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set)
Description
The mean percent change from baseline to the final visit in low-density lipoprotein cholesterol (LDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.
Time Frame
Baseline to 12 Weeks
Secondary Outcome Measure Information:
Title
Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus ABT-335 135 mg Monotherapy (Full Analysis Set)
Description
The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.
Time Frame
Baseline to 12 Weeks
Title
Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus Rosuvastatin 5 mg Monotherapy (Full Analysis Set)
Description
The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Time Frame
Baseline to 12 Weeks
Title
Mean Percent Change From Baseline to the Final Visit in Very-low-density Lipoprotein Cholesterol (VLDL-C) (Full Analysis Set)
Description
The mean percent change from baseline to the final visit in very-low-density lipoprotein cholesterol (VLDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Time Frame
Baseline to 12 Weeks
Title
Mean Percent Change From Baseline to the Final Visit in Apolipoprotein B (ApoB) (Full Analysis Set)
Description
The mean percent change from baseline to the final visit in apolipoprotein B (ApoB), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Time Frame
Baseline to 12 Weeks
Title
Median Percent Change From Baseline to the Final Visit in High Sensitivity C-reactive Protein (hsCRP) (Full Analysis Set)
Description
The median percent change from baseline to the final visit in high sensitivity C-reactive protein (hsCRP), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Time Frame
Baseline to 12 Weeks
Title
Mean Percent Change From Baseline to the Final Visit in Total Cholesterol (Full Analysis Set)
Description
The mean percent change from baseline to the final visit in total cholesterol, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Time Frame
Baseline to 12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Adult male and female participants who voluntarily sign the informed consent. Fasting lipid results following greater than 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. Participant must agree to utilize adequate birth control methods and adhere to the American Heart Association (AHA) diet. Exclusion Criteria Participants with unstable medical conditions, medical conditions considered inappropriate in a clinical trial, or participants who are taking excluded concomitant medications are not allowed in the study. Participants receiving coumarin anticoagulants or systemic cyclosporine.
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# 5469
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Site Reference ID/Investigator# 4428
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209-6802
Country
United States
Facility Name
Site Reference ID/Investigator# 4985
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Site Reference ID/Investigator# 4493
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Site Reference ID/Investigator# 4510
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
Facility Name
Site Reference ID/Investigator# 4431
City
Ozark
State/Province
Alabama
ZIP/Postal Code
36360
Country
United States
Facility Name
Site Reference ID/Investigator# 4519
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35406
Country
United States
Facility Name
Site Reference ID/Investigator# 4395
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Site Reference ID/Investigator# 4483
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85295
Country
United States
Facility Name
Site Reference ID/Investigator# 4411
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Site Reference ID/Investigator# 4417
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Facility Name
Site Reference ID/Investigator# 4702
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Site Reference ID/Investigator# 5593
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Site Reference ID/Investigator# 4503
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Site Reference ID/Investigator# 4530
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Site Reference ID/Investigator# 4458
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
Facility Name
Site Reference ID/Investigator# 4542
City
Fresno
State/Province
California
ZIP/Postal Code
93703
Country
United States
Facility Name
Site Reference ID/Investigator# 4574
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Site Reference ID/Investigator# 4441
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
Site Reference ID/Investigator# 4432
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Site Reference ID/Investigator# 5579
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Site Reference ID/Investigator# 4980
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Site Reference ID/Investigator# 4392
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Site Reference ID/Investigator# 4896
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Site Reference ID/Investigator# 5582
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Facility Name
Site Reference ID/Investigator# 6236
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
Site Reference ID/Investigator# 4442
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Site Reference ID/Investigator# 4419
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Site Reference ID/Investigator# 4391
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Site Reference ID/Investigator# 4401
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Site Reference ID/Investigator# 4453
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Site Reference ID/Investigator# 4490
City
Holly Hill
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Site Reference ID/Investigator# 4420
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Site Reference ID/Investigator# 5011
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Site Reference ID/Investigator# 4444
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32259
Country
United States
Facility Name
Site Reference ID/Investigator# 4399
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458-7200
Country
United States
Facility Name
Site Reference ID/Investigator# 4433
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Site Reference ID/Investigator# 4469
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
Site Reference ID/Investigator# 4525
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
Facility Name
Site Reference ID/Investigator# 4477
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Site Reference ID/Investigator# 4430
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Site Reference ID/Investigator# 4409
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States
Facility Name
Site Reference ID/Investigator# 4416
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Site Reference ID/Investigator# 4528
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Site Reference ID/Investigator# 5103
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Site Reference ID/Investigator# 4446
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Site Reference ID/Investigator# 4524
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32514
Country
United States
Facility Name
Site Reference ID/Investigator# 4505
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Site Reference ID/Investigator# 5580
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Site Reference ID/Investigator# 4494
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Site Reference ID/Investigator# 4407
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Site Reference ID/Investigator# 4512
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Site Reference ID/Investigator# 5478
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
Facility Name
Site Reference ID/Investigator# 4388
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Site Reference ID/Investigator# 4511
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Site Reference ID/Investigator# 4981
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30075
Country
United States
Facility Name
Site Reference ID/Investigator# 4448
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Site Reference ID/Investigator# 4497
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
Site Reference ID/Investigator# 4439
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
Site Reference ID/Investigator# 4472
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60004
Country
United States
Facility Name
Site Reference ID/Investigator# 5585
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
Site Reference ID/Investigator# 4520
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Site Reference ID/Investigator# 4527
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Site Reference ID/Investigator# 4485
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Site Reference ID/Investigator# 4445
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Site Reference ID/Investigator# 4438
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47904
Country
United States
Facility Name
Site Reference ID/Investigator# 5010
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
Site Reference ID/Investigator# 4403
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Site Reference ID/Investigator# 4393
City
Arkansas City
State/Province
Kansas
ZIP/Postal Code
67005
Country
United States
Facility Name
Site Reference ID/Investigator# 4526
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66202
Country
United States
Facility Name
Site Reference ID/Investigator# 4423
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
Site Reference ID/Investigator# 4424
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Site Reference ID/Investigator# 5027
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Site Reference ID/Investigator# 4471
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Site Reference ID/Investigator# 4406
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Site Reference ID/Investigator# 4509
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Facility Name
Site Reference ID/Investigator# 5635
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Site Reference ID/Investigator# 4502
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Site Reference ID/Investigator# 5070
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
Facility Name
Site Reference ID/Investigator# 4412
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01830
Country
United States
Facility Name
Site Reference ID/Investigator# 4487
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01103
Country
United States
Facility Name
Site Reference ID/Investigator# 5533
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Site Reference ID/Investigator# 6237
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Site Reference ID/Investigator# 5583
City
Portage
State/Province
Michigan
ZIP/Postal Code
49024
Country
United States
Facility Name
Site Reference ID/Investigator# 4480
City
Brooklyn Center
State/Province
Minnesota
ZIP/Postal Code
55430
Country
United States
Facility Name
Site Reference ID/Investigator# 4515
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Site Reference ID/Investigator# 4492
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Site Reference ID/Investigator# 5636
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Site Reference ID/Investigator# 4500
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Site Reference ID/Investigator# 4499
City
St. Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
Site Reference ID/Investigator# 4979
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Site Reference ID/Investigator# 4481
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Site Reference ID/Investigator# 4460
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Site Reference ID/Investigator# 4466
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Site Reference ID/Investigator# 5484
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146
Country
United States
Facility Name
Site Reference ID/Investigator# 5444
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States
Facility Name
Site Reference ID/Investigator# 4908
City
Elizabeth
State/Province
New Jersey
ZIP/Postal Code
07202
Country
United States
Facility Name
Site Reference ID/Investigator# 4504
City
South Bound Brook
State/Province
New Jersey
ZIP/Postal Code
08880
Country
United States
Facility Name
Site Reference ID/Investigator# 4394
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Site Reference ID/Investigator# 4402
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08611
Country
United States
Facility Name
Site Reference ID/Investigator# 4427
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Site Reference ID/Investigator# 4463
City
Bronxville
State/Province
New York
ZIP/Postal Code
10708
Country
United States
Facility Name
Site Reference ID/Investigator# 4415
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Site Reference ID/Investigator# 4440
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Site Reference ID/Investigator# 4464
City
Syracuse
State/Province
New York
ZIP/Postal Code
13202
Country
United States
Facility Name
Site Reference ID/Investigator# 4425
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Site Reference ID/Investigator# 4473
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Site Reference ID/Investigator# 4531
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Site Reference ID/Investigator# 4396
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Site Reference ID/Investigator# 5494
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Site Reference ID/Investigator# 4479
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Site Reference ID/Investigator# 4461
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Site Reference ID/Investigator# 4498
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Site Reference ID/Investigator# 4405
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
Country
United States
Facility Name
Site Reference ID/Investigator# 4476
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Site Reference ID/Investigator# 4390
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Site Reference ID/Investigator# 4400
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Site Reference ID/Investigator# 4501
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Site Reference ID/Investigator# 4517
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Site Reference ID/Investigator# 5584
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Site Reference ID/Investigator# 4410
City
Mogadore
State/Province
Ohio
ZIP/Postal Code
44260
Country
United States
Facility Name
Site Reference ID/Investigator# 4443
City
Sandusky
State/Province
Ohio
ZIP/Postal Code
44870
Country
United States
Facility Name
Site Reference ID/Investigator# 4523
City
Warren
State/Province
Ohio
ZIP/Postal Code
44483
Country
United States
Facility Name
Site Reference ID/Investigator# 4488
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Site Reference ID/Investigator# 4451
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Site Reference ID/Investigator# 4422
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Site Reference ID/Investigator# 4482
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Site Reference ID/Investigator# 4467
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Site Reference ID/Investigator# 4470
City
Carlisle
State/Province
Pennsylvania
ZIP/Postal Code
17015
Country
United States
Facility Name
Site Reference ID/Investigator# 5581
City
Downingtown
State/Province
Pennsylvania
ZIP/Postal Code
19335
Country
United States
Facility Name
Site Reference ID/Investigator# 4434
City
Feasterville
State/Province
Pennsylvania
ZIP/Postal Code
19053
Country
United States
Facility Name
Site Reference ID/Investigator# 4478
City
Harleysville
State/Province
Pennsylvania
ZIP/Postal Code
19438-2513
Country
United States
Facility Name
Site Reference ID/Investigator# 4436
City
Jersey Shore
State/Province
Pennsylvania
ZIP/Postal Code
17740
Country
United States
Facility Name
Site Reference ID/Investigator# 4397
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Site Reference ID/Investigator# 4426
City
Melrose Park
State/Province
Pennsylvania
ZIP/Postal Code
19027
Country
United States
Facility Name
Site Reference ID/Investigator# 4894
City
Newtown
State/Province
Pennsylvania
ZIP/Postal Code
18940
Country
United States
Facility Name
Site Reference ID/Investigator# 4496
City
Penndel
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
Site Reference ID/Investigator# 4404
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Site Reference ID/Investigator# 4437
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19115
Country
United States
Facility Name
Site Reference ID/Investigator# 4387
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Facility Name
Site Reference ID/Investigator# 4447
City
Warminster
State/Province
Pennsylvania
ZIP/Postal Code
18974
Country
United States
Facility Name
Site Reference ID/Investigator# 4506
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Site Reference ID/Investigator# 5443
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Site Reference ID/Investigator# 4484
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Site Reference ID/Investigator# 4455
City
Moncks Corner
State/Province
South Carolina
ZIP/Postal Code
29461
Country
United States
Facility Name
Site Reference ID/Investigator# 4513
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Site Reference ID/Investigator# 4521
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
Site Reference ID/Investigator# 4982
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Site Reference ID/Investigator# 5586
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Site Reference ID/Investigator# 4435
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Site Reference ID/Investigator# 4454
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
Site Reference ID/Investigator# 4529
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Site Reference ID/Investigator# 5454
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Site Reference ID/Investigator# 5578
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Site Reference ID/Investigator# 5669
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Site Reference ID/Investigator# 4893
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Site Reference ID/Investigator# 4429
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Site Reference ID/Investigator# 4457
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78224
Country
United States
Facility Name
Site Reference ID/Investigator# 4465
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-4801
Country
United States
Facility Name
Site Reference ID/Investigator# 4508
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site Reference ID/Investigator# 4892
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site Reference ID/Investigator# 5948
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site Reference ID/Investigator# 4413
City
Temple
State/Province
Texas
ZIP/Postal Code
76502
Country
United States
Facility Name
Site Reference ID/Investigator# 4456
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22044
Country
United States
Facility Name
Site Reference ID/Investigator# 4459
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Site Reference ID/Investigator# 4408
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Site Reference ID/Investigator# 4421
City
Lakewood
State/Province
Washington
ZIP/Postal Code
98499
Country
United States
Facility Name
Site Reference ID/Investigator# 4468
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21174145
Citation
Rosenson RS, Carlson DM, Kelly MT, Setze CM, Hirshberg B, Stolzenbach JC, Williams LA. Achievement of lipid targets with the combination of rosuvastatin and fenofibric Acid in patients with type 2 diabetes mellitus. Cardiovasc Drugs Ther. 2011 Feb;25(1):47-57. doi: 10.1007/s10557-010-6273-5.
Results Reference
derived
PubMed Identifier
20953684
Citation
Roth EM, Rosenson RS, Carlson DM, Fukumoto SM, Setze CM, Blasetto JW, Khurmi NS, Stolzenbach JC, Williams LA. Efficacy and safety of rosuvastatin 5 mg in combination with fenofibric acid 135 mg in patients with mixed dyslipidemia - a phase 3 study. Cardiovasc Drugs Ther. 2010 Dec;24(5-6):421-8. doi: 10.1007/s10557-010-6266-4.
Results Reference
derived

Learn more about this trial

A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects With Dyslipidemia

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