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Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides

NCT ID: NCT00812955

Last Updated: 2012-10-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

474 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-06-30

Brief Summary

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The primary purpose of this study is to test the effect and safety of three different doses of ABT-143 compared to simvastatin in subjects with elevated levels of low density lipoprotein cholesterol ("bad cholesterol") and triglycerides.

Detailed Description

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There are 4 treatment groups in the study: ABT-143 capsules 20/135 mg, ABT-143 capsules 10/135 mg, ABT-143 5/135 mg, and simvastatin capsules 40 mg. The primary outcome measure only compares 2 of these groups: ABT-143 capsules 20/135 mg and the simvastatin capsules 40 mg groups, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure . Secondary outcome measure (mean percent change in LDL-C comparing ABT-143 capsules 10/135 mg to simvastatin capsules 40 mg) only compares these 2 groups: ABT-143 capsules 10/135 mg and simvastatin capsules 40 mg, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure. Secondary outcome measure (mean percent change in LDL-C comparing ABT-143 capsules 5/135 mg to simvastatin capsules 40 mg) only compares these 2 groups: ABT-143 capsules 5/135 mg and simvastatin capsules 40 mg, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure. For the other pre-specified outcome measures, median percent change in triglycerides from baseline to the final visit and mean percent change in HDL-C from baseline to the final visit for the full analysis sets, all 3 ABT-143 capsules 20/135 mg, 10/135 mg, and 5/135 mg groups were compared to the simvastatin capsules 40 mg group, therefore there are results for all 4 treatment groups for these outcome measures.

Conditions

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Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia

Keywords

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Dyslipidemia Hypercholesterolemia Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A - ABT-143 capsules 5/135 mg

ABT-143 capsules 5/135 mg - ABT-143 (rosuvastatin 5 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks

Group Type EXPERIMENTAL

ABT-143

Intervention Type DRUG

Once daily for 8 weeks

B - ABT-143 capsules 10/135 mg

ABT-143 capsules 10/135 mg - ABT-143 (rosuvastatin 10 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks

Group Type EXPERIMENTAL

ABT-143

Intervention Type DRUG

Once daily for 8 weeks

C - ABT-143 capsules 20/135 mg

ABT-143 capsules 20/135 mg - ABT-143 (rosuvastatin 20 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks

Group Type EXPERIMENTAL

ABT-143

Intervention Type DRUG

Once daily for 8 weeks

D - Simvastatin capsules 40 mg

Simvastatin capsules 40 mg daily for 8 weeks

Group Type ACTIVE_COMPARATOR

simvastatin

Intervention Type DRUG

Once daily for 8 weeks simvastatin capsules 40 mg

Interventions

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ABT-143

Once daily for 8 weeks

Intervention Type DRUG

simvastatin

Once daily for 8 weeks simvastatin capsules 40 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants with hypercholesterolemia and hypertriglyceridemia.
* Participants had the following fasting lipid results following a greater than or equal to 12 hour fasting period (measured at the Screening Visit(s)):

* Triglycerides level greater than or equal to 150 milligrams/deciliter (mg/dL) and less than 400 milligrams/deciliter, and
* Low-density lipoprotein cholesterol greater than or equal to 160 milligrams/deciliter and less than or equal to 240 milligrams/deciliter.

Exclusion Criteria

* Participants with certain chronic or unstable medical conditions.
* Participants receiving coumarin anticoagulants, systemic cyclosporins, or certain other medications.
* Pregnant or lactating women, or women intending to become pregnant.
* Participants with diabetes mellitus that is poorly controlled.
* Participant was of Asian ancestry (having Filipino, Chinese, Japanese, Korean, Vietnamese, or Asian-Indian origin).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Torbjörn Lundström, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Site Reference ID/Investigator# 12654

Birmingham, Alabama, United States

Site Status

Site Reference ID/Investigator# 12634

Columbiana, Alabama, United States

Site Status

Site Reference ID/Investigator# 12559

Huntsville, Alabama, United States

Site Status

Site Reference ID/Investigator# 12499

Ozark, Alabama, United States

Site Status

Site Reference ID/Investigator# 12673

Chandler, Arizona, United States

Site Status

Site Reference ID/Investigator# 17282

Scottsdale, Arizona, United States

Site Status

Site Reference ID/Investigator# 12657

Little Rock, Arkansas, United States

Site Status

Site Reference ID/Investigator# 12489

Anaheim, California, United States

Site Status

Site Reference ID/Investigator# 12495

Carmichael, California, United States

Site Status

Site Reference ID/Investigator# 12467

Chula Vista, California, United States

Site Status

Site Reference ID/Investigator# 12498

Long Beach, California, United States

Site Status

Site Reference ID/Investigator# 12602

Los Angeles, California, United States

Site Status

Site Reference ID/Investigator# 12510

Norwalk, California, United States

Site Status

Site Reference ID/Investigator# 12550

Palm Desert, California, United States

Site Status

Site Reference ID/Investigator# 16503

Roseville, California, United States

Site Status

Site Reference ID/Investigator# 12678

Sacramento, California, United States

Site Status

Site Reference ID/Investigator# 14241

Sacramento, California, United States

Site Status

Site Reference ID/Investigator# 12473

San Diego, California, United States

Site Status

Site Reference ID/Investigator# 12497

Walnut Creek, California, United States

Site Status

Site Reference ID/Investigator# 12680

West Hills, California, United States

Site Status

Site Reference ID/Investigator# 12461

Colorado Springs, Colorado, United States

Site Status

Site Reference ID/Investigator# 12600

Colorado Springs, Colorado, United States

Site Status

Site Reference ID/Investigator# 12679

Waterbury, Connecticut, United States

Site Status

Site Reference ID/Investigator# 12598

Clearwater, Florida, United States

Site Status

Site Reference ID/Investigator# 15542

Coral Gables, Florida, United States

Site Status

Site Reference ID/Investigator# 12477

Daytona Beach, Florida, United States

Site Status

Site Reference ID/Investigator# 12668

Delray Beach, Florida, United States

Site Status

Site Reference ID/Investigator# 15483

Fort Lauderdale, Florida, United States

Site Status

Site Reference ID/Investigator# 12645

Fort Myers, Florida, United States

Site Status

Site Reference ID/Investigator# 12672

Hollywood, Florida, United States

Site Status

Site Reference ID/Investigator# 17504

Jacksonville, Florida, United States

Site Status

Site Reference ID/Investigator# 12781

Jacksonville, Florida, United States

Site Status

Site Reference ID/Investigator# 12665

Jupiter, Florida, United States

Site Status

Site Reference ID/Investigator# 12682

Longwood, Florida, United States

Site Status

Site Reference ID/Investigator# 15486

Melbourne, Florida, United States

Site Status

Site Reference ID/Investigator# 12502

New Port Richey, Florida, United States

Site Status

Site Reference ID/Investigator# 12647

Ocala, Florida, United States

Site Status

Site Reference ID/Investigator# 12520

Orlando, Florida, United States

Site Status

Site Reference ID/Investigator# 12687

Ormond Beach, Florida, United States

Site Status

Site Reference ID/Investigator# 12583

Sarasota, Florida, United States

Site Status

Site Reference ID/Investigator# 12652

Tampa, Florida, United States

Site Status

Site Reference ID/Investigator# 12557

West Palm Beach, Florida, United States

Site Status

Site Reference ID/Investigator# 12621

Winter Haven, Florida, United States

Site Status

Site Reference ID/Investigator# 16505

Winter Park, Florida, United States

Site Status

Site Reference ID/Investigator# 12675

Augusta, Georgia, United States

Site Status

Site Reference ID/Investigator# 12620

Dunwoody, Georgia, United States

Site Status

Site Reference ID/Investigator# 12653

Roswell, Georgia, United States

Site Status

Site Reference ID/Investigator# 12555

Suwanee, Georgia, United States

Site Status

Site Reference ID/Investigator# 12787

Woodstock, Georgia, United States

Site Status

Site Reference ID/Investigator# 12514

Chicago, Illinois, United States

Site Status

Site Reference ID/Investigator# 12487

Peoria, Illinois, United States

Site Status

Site Reference ID/Investigator# 12627

Peoria, Illinois, United States

Site Status

Site Reference ID/Investigator# 12529

Evansville, Indiana, United States

Site Status

Site Reference ID/Investigator# 12688

Indianapolis, Indiana, United States

Site Status

Site Reference ID/Investigator# 15485

South Bend, Indiana, United States

Site Status

Site Reference ID/Investigator# 12676

Arkansas City, Kansas, United States

Site Status

Site Reference ID/Investigator# 12597

Wichita, Kansas, United States

Site Status

Site Reference ID/Investigator# 12472

Louisville, Kentucky, United States

Site Status

Site Reference ID/Investigator# 12658

Mount Sterling, Kentucky, United States

Site Status

Site Reference ID/Investigator# 12586

Baltimore, Maryland, United States

Site Status

Site Reference ID/Investigator# 12480

Bethesda, Maryland, United States

Site Status

Site Reference ID/Investigator# 12638

Oxon Hill, Maryland, United States

Site Status

Site Reference ID/Investigator# 12513

Springfield, Massachusetts, United States

Site Status

Site Reference ID/Investigator# 12663

Kalamazoo, Michigan, United States

Site Status

Site Reference ID/Investigator# 12609

Brooklyn Center, Minnesota, United States

Site Status

Site Reference ID/Investigator# 16622

Edina, Minnesota, United States

Site Status

Site Reference ID/Investigator# 12625

Jackson, Mississippi, United States

Site Status

Site Reference ID/Investigator# 12560

Olive Branch, Mississippi, United States

Site Status

Site Reference ID/Investigator# 12534

City of Saint Peters, Missouri, United States

Site Status

Site Reference ID/Investigator# 12677

St Louis, Missouri, United States

Site Status

Site Reference ID/Investigator# 12592

Billings, Montana, United States

Site Status

Site Reference ID/Investigator# 12655

Omaha, Nebraska, United States

Site Status

Site Reference ID/Investigator# 12587

Las Vegas, Nevada, United States

Site Status

Site Reference ID/Investigator# 12554

Berlin, New Jersey, United States

Site Status

Site Reference ID/Investigator# 12637

Elizabeth, New Jersey, United States

Site Status

Site Reference ID/Investigator# 12463

Hillsborough, New Jersey, United States

Site Status

Site Reference ID/Investigator# 12660

Trenton, New Jersey, United States

Site Status

Site Reference ID/Investigator# 12506

Albuquerque, New Mexico, United States

Site Status

Site Reference ID/Investigator# 12539

Johnson City, New York, United States

Site Status

Site Reference ID/Investigator# 12631

Syracuse, New York, United States

Site Status

Site Reference ID/Investigator# 17503

Cary, North Carolina, United States

Site Status

Site Reference ID/Investigator# 12650

Charlotte, North Carolina, United States

Site Status

Site Reference ID/Investigator# 12504

Charlotte, North Carolina, United States

Site Status

Site Reference ID/Investigator# 12558

Charlotte, North Carolina, United States

Site Status

Site Reference ID/Investigator# 12671

Charlotte, North Carolina, United States

Site Status

Site Reference ID/Investigator# 12527

Hickory, North Carolina, United States

Site Status

Site Reference ID/Investigator# 12608

Morehead City, North Carolina, United States

Site Status

Site Reference ID/Investigator# 12535

Salisbury, North Carolina, United States

Site Status

Site Reference ID/Investigator# 12656

Statesville, North Carolina, United States

Site Status

Site Reference ID/Investigator# 17641

Wilmington, North Carolina, United States

Site Status

Site Reference ID/Investigator# 12606

Winston-Salem, North Carolina, United States

Site Status

Site Reference ID/Investigator# 12614

Akron, Ohio, United States

Site Status

Site Reference ID/Investigator# 12662

Cincinnati, Ohio, United States

Site Status

Site Reference ID/Investigator# 12545

Cincinnati, Ohio, United States

Site Status

Site Reference ID/Investigator# 12640

Kettering, Ohio, United States

Site Status

Site Reference ID/Investigator# 12786

Mason, Ohio, United States

Site Status

Site Reference ID/Investigator# 12630

Warren, Ohio, United States

Site Status

Site Reference ID/Investigator# 12551

Oklahoma City, Oklahoma, United States

Site Status

Site Reference ID/Investigator# 12611

Tulsa, Oklahoma, United States

Site Status

Site Reference ID/Investigator# 12585

Medford, Oregon, United States

Site Status

Site Reference ID/Investigator# 12610

Beaver, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 12589

Duncansville, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 12607

Harleysville, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 12641

Jersey Shore, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 12507

Melrose Park, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 12624

Perkasie, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 12669

Philadelphia, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 12788

Philadelphia, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 12525

Pittsburgh, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 12601

Tipton, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 12686

Warminster, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 12623

Mt. Pleasant, South Carolina, United States

Site Status

Site Reference ID/Investigator# 12681

Mt. Pleasant, South Carolina, United States

Site Status

Site Reference ID/Investigator# 12485

Simpsonville, South Carolina, United States

Site Status

Site Reference ID/Investigator# 12639

Summerville, South Carolina, United States

Site Status

Site Reference ID/Investigator# 15642

Germantown, Tennessee, United States

Site Status

Site Reference ID/Investigator# 12643

Jackson, Tennessee, United States

Site Status

Site Reference ID/Investigator# 12470

Dallas, Texas, United States

Site Status

Site Reference ID/Investigator# 16081

Dallas, Texas, United States

Site Status

Site Reference ID/Investigator# 12492

Dallas, Texas, United States

Site Status

Site Reference ID/Investigator# 12464

Fort Worth, Texas, United States

Site Status

Site Reference ID/Investigator# 12646

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 16601

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 12540

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 12466

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 12622

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 12538

Norfolk, Virginia, United States

Site Status

Site Reference ID/Investigator# 12616

Richmond, Virginia, United States

Site Status

Site Reference ID/Investigator# 12476

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Roth EM, McKenney JM, Kelly MT, Setze CM, Carlson DM, Gold A, Stolzenbach JC, Williams LA, Jones PH. Efficacy and safety of rosuvastatin and fenofibric acid combination therapy versus simvastatin monotherapy in patients with hypercholesterolemia and hypertriglyceridemia: a randomized, double-blind study. Am J Cardiovasc Drugs. 2010;10(3):175-86. doi: 10.2165/11533430-000000000-00000.

Reference Type DERIVED
PMID: 20524719 (View on PubMed)

Other Identifiers

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M10-667

Identifier Type: -

Identifier Source: org_study_id