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

September 27, 2012 updated by: AstraZeneca

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
760

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ABT-335 and Rosuvastatin Calcium
ABT-335 135mg in combination with rosuvastatin calcium 5mg administered orally, once daily for 12 weeks
Drug: ABT-335 and rosuvastatin calcium
ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
Other Names:
  • ABT-335 / Rosuvastatin Combination (ABT-143)
Active Comparator: ABT-335
ABT-335 135mg monotherapy administered orally, once daily for 12 weeks
Drug: ABT-335
ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
Other Names:
  • fenofibric acid
Active Comparator: Rosuvastatin Calcium
Rosuvastatin calcium 5mg monotherapy administered orally, once daily for 12 weeks
Drug: rosuvastatin calcium
Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Other Names:
  • Rosuvastatin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set)
Time Frame: Baseline to 12 Weeks
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.
Baseline to 12 Weeks
Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set)
Time Frame: Baseline to 12 Weeks
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.
Baseline to 12 Weeks
Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set)
Time Frame: Baseline to 12 Weeks
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.
Baseline to 12 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Baseline to 12 Weeks
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.
Baseline to 12 Weeks
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)
Time Frame: Baseline to 12 Weeks
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.
Baseline to 12 Weeks
Mean Percent Change From Baseline to the Final Visit in Very-low-density Lipoprotein Cholesterol (VLDL-C) (Full Analysis Set)
Time Frame: Baseline to 12 Weeks
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.
Baseline to 12 Weeks
Mean Percent Change From Baseline to the Final Visit in Apolipoprotein B (ApoB) (Full Analysis Set)
Time Frame: Baseline to 12 Weeks
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.
Baseline to 12 Weeks
Median Percent Change From Baseline to the Final Visit in High Sensitivity C-reactive Protein (hsCRP) (Full Analysis Set)
Time Frame: Baseline to 12 Weeks
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.
Baseline to 12 Weeks
Mean Percent Change From Baseline to the Final Visit in Total Cholesterol (Full Analysis Set)
Time Frame: Baseline to 12 Weeks
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.
Baseline to 12 Weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M06-844

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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