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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

760

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

  • 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

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
Intervention / Treatment
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

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

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

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

April 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

April 19, 2007

First Submitted That Met QC Criteria

April 19, 2007

First Posted (Estimate)

April 20, 2007

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

Additional Relevant MeSH Terms

Other Study ID 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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