Clinical trial NCT00463606: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Dyslipidemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-04-20
Enrollment: 760
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set)
timeFrame: Baseline to 12 Weeks
measure: Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set)
timeFrame: Baseline to 12 Weeks
measure: Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set)
timeFrame: Baseline to 12 Weeks
Secondary outcomes:
measure: 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)
timeFrame: Baseline to 12 Weeks
measure: 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)
timeFrame: Baseline to 12 Weeks
measure: Mean Percent Change From Baseline to the Final Visit in Very-low-density Lipoprotein Cholesterol (VLDL-C) (Full Analysis Set)
timeFrame: Baseline to 12 Weeks
measure: Mean Percent Change From Baseline to the Final Visit in Apolipoprotein B (ApoB) (Full Analysis Set)
timeFrame: Baseline to 12 Weeks
measure: Median Percent Change From Baseline to the Final Visit in High Sensitivity C-reactive Protein (hsCRP) (Full Analysis Set)
timeFrame: Baseline to 12 Weeks
measure: Mean Percent Change From Baseline to the Final Visit in Total Cholesterol (Full Analysis Set)
timeFrame: Baseline to 12 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site Reference ID/Investigator# 5469
state: Alabama
city: Birmingham
country: United States
facility: Site Reference ID/Investigator# 4428
state: Alabama
city: Birmingham
country: United States
facility: Site Reference ID/Investigator# 4985
state: Alabama
city: Huntsville
country: United States
facility: Site Reference ID/Investigator# 4493
state: Alabama
city: Huntsville
country: United States
facility: Site Reference ID/Investigator# 4510
state: Alabama
city: Ozark
country: United States
facility: Site Reference ID/Investigator# 4431
state: Alabama
city: Tuscaloosa
country: United States
facility: Site Reference ID/Investigator# 4519
state: Alabama
city: Chandler
country: United States
facility: Site Reference ID/Investigator# 4395
state: Arizona
city: Gilbert
country: United States
facility: Site Reference ID/Investigator# 4483
state: Arizona
city: Scottsdale
country: United States
facility: Site Reference ID/Investigator# 4411
state: Arizona
city: Little Rock
country: United States
facility: Site Reference ID/Investigator# 4417
state: Arkansas
city: Anaheim
country: United States
facility: Site Reference ID/Investigator# 4702
state: California
city: Chula Vista
country: United States
facility: Site Reference ID/Investigator# 5593
state: California
city: Concord
country: United States
facility: Site Reference ID/Investigator# 4503
state: California
city: Encinitas
country: United States
facility: Site Reference ID/Investigator# 4530
state: California
city: Fair Oaks
country: United States
facility: Site Reference ID/Investigator# 4458
state: California
city: Fresno
country: United States
facility: Site Reference ID/Investigator# 4542
state: California
city: Fresno
country: United States
facility: Site Reference ID/Investigator# 4574
state: California
city: Lincoln
country: United States
facility: Site Reference ID/Investigator# 4441
state: California
city: Long Beach
country: United States
facility: Site Reference ID/Investigator# 4432
state: California
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 5579
state: California
city: Norwalk
country: United States
facility: Site Reference ID/Investigator# 4980
state: California
city: Sacramento
country: United States
facility: Site Reference ID/Investigator# 4392
state: California
city: Sacramento
country: United States
facility: Site Reference ID/Investigator# 4896
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 5582
state: California
city: West Hills
country: United States
facility: Site Reference ID/Investigator# 6236
state: California
city: Aurora
country: United States
facility: Site Reference ID/Investigator# 4442
state: Colorado
city: Colorado Springs
country: United States
facility: Site Reference ID/Investigator# 4419
state: Colorado
city: Waterbury
country: United States
facility: Site Reference ID/Investigator# 4391
state: Connecticut
city: Coral Gables
country: United States
facility: Site Reference ID/Investigator# 4401
state: Florida
city: Fort Lauderdale
country: United States
facility: Site Reference ID/Investigator# 4453
state: Florida
city: Holly Hill
country: United States
facility: Site Reference ID/Investigator# 4490
state: Florida
city: Hollywood
country: United States
facility: Site Reference ID/Investigator# 4420
state: Florida
city: Jacksonville
country: United States
facility: Site Reference ID/Investigator# 5011
state: Florida
city: Jacksonville
country: United States
facility: Site Reference ID/Investigator# 4444
state: Florida
city: Jupiter
country: United States
facility: Site Reference ID/Investigator# 4399
state: Florida
city: Kissimmee
country: United States
facility: Site Reference ID/Investigator# 4433
state: Florida
city: Largo
country: United States
facility: Site Reference ID/Investigator# 4469
state: Florida
city: Melbourne
country: United States
facility: Site Reference ID/Investigator# 4525
state: Florida
city: Miami
country: United States
facility: Site Reference ID/Investigator# 4477
state: Florida
city: New Port Richey
country: United States
facility: Site Reference ID/Investigator# 4430
state: Florida
city: New Smyrna Beach
country: United States
facility: Site Reference ID/Investigator# 4409
state: Florida
city: Ocala
country: United States
facility: Site Reference ID/Investigator# 4416
state: Florida
city: Ocala
country: United States
facility: Site Reference ID/Investigator# 4528
state: Florida
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 5103
state: Florida
city: Ormond Beach
country: United States
facility: Site Reference ID/Investigator# 4446
state: Florida
city: Pensacola
country: United States
facility: Site Reference ID/Investigator# 4524
state: Florida
city: Sarasota
country: United States
facility: Site Reference ID/Investigator# 4505
state: Florida
city: Sarasota
country: United States
facility: Site Reference ID/Investigator# 5580
state: Florida
city: West Palm Beach
country: United States
facility: Site Reference ID/Investigator# 4494
state: Florida
city: West Palm Beach
country: United States
facility: Site Reference ID/Investigator# 4407
state: Florida
city: Winter Haven
country: United States
facility: Site Reference ID/Investigator# 4512
state: Florida
city: Blue Ridge
country: United States
facility: Site Reference ID/Investigator# 5478
state: Georgia
city: Decatur
country: United States
facility: Site Reference ID/Investigator# 4388
state: Georgia
city: Dunwoody
country: United States
facility: Site Reference ID/Investigator# 4511
state: Georgia
city: Roswell
country: United States
facility: Site Reference ID/Investigator# 4981
state: Georgia
city: Roswell
country: United States
facility: Site Reference ID/Investigator# 4448
state: Georgia
city: Suwanee
country: United States
facility: Site Reference ID/Investigator# 4497
state: Georgia
city: Woodstock
country: United States
facility: Site Reference ID/Investigator# 4439
state: Georgia
city: Arlington Heights
country: United States
facility: Site Reference ID/Investigator# 4472
state: Illinois
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 5585
state: Illinois
city: Peoria
country: United States
facility: Site Reference ID/Investigator# 4520
state: Illinois
city: Avon
country: United States
facility: Site Reference ID/Investigator# 4527
state: Indiana
city: Evansville
country: United States
facility: Site Reference ID/Investigator# 4485
state: Indiana
city: Indianapolis
country: United States
facility: Site Reference ID/Investigator# 4445
state: Indiana
city: Lafayette
country: United States
facility: Site Reference ID/Investigator# 4438
state: Indiana
city: Newburgh
country: United States
facility: Site Reference ID/Investigator# 5010
state: Indiana
city: Iowa City
country: United States
facility: Site Reference ID/Investigator# 4403
state: Iowa
city: Arkansas City
country: United States
facility: Site Reference ID/Investigator# 4393
state: Kansas
city: Overland Park
country: United States
facility: Site Reference ID/Investigator# 4526
state: Kansas
city: Wichita
country: United States
facility: Site Reference ID/Investigator# 4423
state: Kansas
city: Wichita
country: United States
facility: Site Reference ID/Investigator# 4424
state: Kansas
city: Lexington
country: United States
facility: Site Reference ID/Investigator# 5027
state: Kentucky
city: Louisville
country: United States
facility: Site Reference ID/Investigator# 4471
state: Kentucky
city: New Orleans
country: United States
facility: Site Reference ID/Investigator# 4406
state: Louisiana
city: Slidell
country: United States
facility: Site Reference ID/Investigator# 4509
state: Louisiana
city: Auburn
country: United States
facility: Site Reference ID/Investigator# 5635
state: Maine
city: Scarborough
country: United States
facility: Site Reference ID/Investigator# 4502
state: Maine
city: Baltimore
country: United States
facility: Site Reference ID/Investigator# 5070
state: Maryland
city: Haverhill
country: United States
facility: Site Reference ID/Investigator# 4412
state: Massachusetts
city: Springfield
country: United States
facility: Site Reference ID/Investigator# 4487
state: Massachusetts
city: Ann Arbor
country: United States
facility: Site Reference ID/Investigator# 5533
state: Michigan
city: Ann Arbor
country: United States
facility: Site Reference ID/Investigator# 6237
state: Michigan
city: Portage
country: United States
facility: Site Reference ID/Investigator# 5583
state: Michigan
city: Brooklyn Center
country: United States
facility: Site Reference ID/Investigator# 4480
state: Minnesota
city: Jackson
country: United States
facility: Site Reference ID/Investigator# 4515
state: Mississippi
city: Olive Branch
country: United States
facility: Site Reference ID/Investigator# 4492
state: Mississippi
city: Tupelo
country: United States
facility: Site Reference ID/Investigator# 5636
state: Mississippi
city: Kansas City
country: United States
facility: Site Reference ID/Investigator# 4500
state: Missouri
city: St. Peters
country: United States
facility: Site Reference ID/Investigator# 4499
state: Missouri
city: Billings
country: United States
facility: Site Reference ID/Investigator# 4979
state: Montana
city: Missoula
country: United States
facility: Site Reference ID/Investigator# 4481
state: Montana
city: Las Vegas
country: United States
facility: Site Reference ID/Investigator# 4460
state: Nevada
city: Las Vegas
country: United States
facility: Site Reference ID/Investigator# 4466
state: Nevada
city: Las Vegas
country: United States
facility: Site Reference ID/Investigator# 5484
state: Nevada
city: Concord
country: United States
facility: Site Reference ID/Investigator# 5444
state: New Hampshire
city: Elizabeth
country: United States
facility: Site Reference ID/Investigator# 4908
state: New Jersey
city: South Bound Brook
country: United States
facility: Site Reference ID/Investigator# 4504
state: New Jersey
city: Toms River
country: United States
facility: Site Reference ID/Investigator# 4394
state: New Jersey
city: Trenton
country: United States
facility: Site Reference ID/Investigator# 4402
state: New Jersey
city: Albuquerque
country: United States
facility: Site Reference ID/Investigator# 4427
state: New Mexico
city: Bronxville
country: United States
facility: Site Reference ID/Investigator# 4463
state: New York
city: New York
country: United States
facility: Site Reference ID/Investigator# 4415
state: New York
city: Rochester
country: United States
facility: Site Reference ID/Investigator# 4440
state: New York
city: Syracuse
country: United States
facility: Site Reference ID/Investigator# 4464
state: New York
city: Williamsville
country: United States
facility: Site Reference ID/Investigator# 4425
state: New York
city: Asheville
country: United States
facility: Site Reference ID/Investigator# 4473
state: North Carolina
city: Charlotte
country: United States
facility: Site Reference ID/Investigator# 4531
state: North Carolina
city: Charlotte
country: United States
facility: Site Reference ID/Investigator# 4396
state: North Carolina
city: Hickory
country: United States
facility: Site Reference ID/Investigator# 5494
state: North Carolina
city: Morehead City
country: United States
facility: Site Reference ID/Investigator# 4479
state: North Carolina
city: Raleigh
country: United States
facility: Site Reference ID/Investigator# 4461
state: North Carolina
city: Salisbury
country: United States
facility: Site Reference ID/Investigator# 4498
state: North Carolina
city: Statesville
country: United States
facility: Site Reference ID/Investigator# 4405
state: North Carolina
city: Winston-Salem
country: United States
facility: Site Reference ID/Investigator# 4476
state: North Carolina
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 4390
state: Ohio
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 4400
state: Ohio
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 4501
state: Ohio
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 4517
state: Ohio
city: Columbus
country: United States
facility: Site Reference ID/Investigator# 5584
state: Ohio
city: Mogadore
country: United States
facility: Site Reference ID/Investigator# 4410
state: Ohio
city: Sandusky
country: United States
facility: Site Reference ID/Investigator# 4443
state: Ohio
city: Warren
country: United States
facility: Site Reference ID/Investigator# 4523
state: Ohio
city: Oklahoma City
country: United States
facility: Site Reference ID/Investigator# 4488
state: Oklahoma
city: Oklahoma City
country: United States
facility: Site Reference ID/Investigator# 4451
state: Oklahoma
city: Tulsa
country: United States
facility: Site Reference ID/Investigator# 4422
state: Oklahoma
city: Tulsa
country: United States
facility: Site Reference ID/Investigator# 4482
state: Oklahoma
city: Medford
country: United States
facility: Site Reference ID/Investigator# 4467
state: Oregon
city: Carlisle
country: United States
facility: Site Reference ID/Investigator# 4470
state: Pennsylvania
city: Downingtown
country: United States
facility: Site Reference ID/Investigator# 5581
state: Pennsylvania
city: Feasterville
country: United States
facility: Site Reference ID/Investigator# 4434
state: Pennsylvania
city: Harleysville
country: United States
facility: Site Reference ID/Investigator# 4478
state: Pennsylvania
city: Jersey Shore
country: United States
facility: Site Reference ID/Investigator# 4436
state: Pennsylvania
city: Lansdale
country: United States
facility: Site Reference ID/Investigator# 4397
state: Pennsylvania
city: Melrose Park
country: United States
facility: Site Reference ID/Investigator# 4426
state: Pennsylvania
city: Newtown
country: United States
facility: Site Reference ID/Investigator# 4894
state: Pennsylvania
city: Penndel
country: United States
facility: Site Reference ID/Investigator# 4496
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 4404
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 4437
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 4387
state: Pennsylvania
city: Warminster
country: United States
facility: Site Reference ID/Investigator# 4447
state: Pennsylvania
city: Charleston
country: United States
facility: Site Reference ID/Investigator# 4506
state: South Carolina
city: Greenville
country: United States
facility: Site Reference ID/Investigator# 5443
state: South Carolina
city: Greer
country: United States
facility: Site Reference ID/Investigator# 4484
state: South Carolina
city: Moncks Corner
country: United States
facility: Site Reference ID/Investigator# 4455
state: South Carolina
city: Mount Pleasant
country: United States
facility: Site Reference ID/Investigator# 4513
state: South Carolina
city: Simpsonville
country: United States
facility: Site Reference ID/Investigator# 4521
state: South Carolina
city: Summerville
country: United States
facility: Site Reference ID/Investigator# 4982
state: South Carolina
city: Sioux Falls
country: United States
facility: Site Reference ID/Investigator# 5586
state: South Dakota
city: Jackson
country: United States
facility: Site Reference ID/Investigator# 4435
state: Tennessee
city: Johnson City
country: United States
facility: Site Reference ID/Investigator# 4454
state: Tennessee
city: Nashville
country: United States
facility: Site Reference ID/Investigator# 4529
state: Tennessee
city: Arlington
country: United States
facility: Site Reference ID/Investigator# 5454
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 5578
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 5669
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 4893
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 4429
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 4457
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 4465
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 4508
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 4892
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 5948
state: Texas
city: Temple
country: United States
facility: Site Reference ID/Investigator# 4413
state: Texas
city: Falls Church
country: United States
facility: Site Reference ID/Investigator# 4456
state: Virginia
city: Richmond
country: United States
facility: Site Reference ID/Investigator# 4459
state: Virginia
city: Richmond
country: United States
facility: Site Reference ID/Investigator# 4408
state: Virginia
city: Lakewood
country: United States
facility: Site Reference ID/Investigator# 4421
state: Washington
city: Madison
country: United States
facility: Site Reference ID/Investigator# 4468
state: Wisconsin
Study officials:
affiliation: AstraZeneca
name: Torbjörn Lundström, MD
role: STUDY_DIRECTOR
References:
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.
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.