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

NCT00812955 | Completed Phase 3 Results

• 1 other identifier: M10-667
• Study Type: interventional
• Target: 474
• Locations: 1 country
• Sites: 129

Brief Summary

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.

Conditions

Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia

Keywords

Dyslipidemia; Hypercholesterolemia; Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

• Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set)

  The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following two treatment groups: ABT-143 capsules 20/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.

  Baseline to 8 weeks

Secondary Outcomes (2)

• Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 10/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set)

  Baseline to 8 weeks

• Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 5/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set)

  Baseline to 8 weeks

Other Outcomes (2)

• Median Percent Change in Triglycerides From Baseline to the Final Visit (Full Analysis Set)

  Baseline to 8 weeks

• Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to the Final Visit (Full Analysis Set)

  Baseline to 8 weeks

Study Arms (4)

A - ABT-143 capsules 5/135 mg

EXPERIMENTAL

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

Drug: ABT-143

B - ABT-143 capsules 10/135 mg

EXPERIMENTAL

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

Drug: ABT-143

C - ABT-143 capsules 20/135 mg

EXPERIMENTAL

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

Drug: ABT-143

D - Simvastatin capsules 40 mg

ACTIVE COMPARATOR

Simvastatin capsules 40 mg daily for 8 weeks

Drug: simvastatin

Interventions

ABT-143 DRUG

Once daily for 8 weeks

A - ABT-143 capsules 5/135 mg; B - ABT-143 capsules 10/135 mg; C - ABT-143 capsules 20/135 mg

simvastatin DRUG

Once daily for 8 weeks simvastatin capsules 40 mg

D - Simvastatin capsules 40 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (129)

Site Reference ID/Investigator# 12654

Birmingham, Alabama, 35235, United States

Location

Site Reference ID/Investigator# 12634

Columbiana, Alabama, 35051, United States

Location

Site Reference ID/Investigator# 12559

Huntsville, Alabama, 35801, United States

Location

Site Reference ID/Investigator# 12499

Ozark, Alabama, 36360, United States

Location

Site Reference ID/Investigator# 12673

Chandler, Arizona, 85225, United States

Location

Site Reference ID/Investigator# 17282

Scottsdale, Arizona, 85251, United States

Location

Site Reference ID/Investigator# 12657

Little Rock, Arkansas, 72204, United States

Location

Site Reference ID/Investigator# 12489

Anaheim, California, 92804, United States

Location

Site Reference ID/Investigator# 12495

Carmichael, California, 95608, United States

Location

Site Reference ID/Investigator# 12467

Chula Vista, California, 91911, United States

Location

Site Reference ID/Investigator# 12498

Long Beach, California, 90806, United States

Location

Site Reference ID/Investigator# 12602

Los Angeles, California, 90057, United States

Location

Site Reference ID/Investigator# 12510

Norwalk, California, 90650, United States

Location

Site Reference ID/Investigator# 12550

Palm Desert, California, 92260, United States

Location

Site Reference ID/Investigator# 16503

Roseville, California, 95661, United States

Location

Site Reference ID/Investigator# 12678

Sacramento, California, 95825, United States

Location

Site Reference ID/Investigator# 14241

Sacramento, California, 95825, United States

Location

Site Reference ID/Investigator# 12473

San Diego, California, 92123, United States

Location

Site Reference ID/Investigator# 12497

Walnut Creek, California, 94598, United States

Location

Site Reference ID/Investigator# 12680

West Hills, California, 91307, United States

Location

Site Reference ID/Investigator# 12461

Colorado Springs, Colorado, 80904, United States

Location

Site Reference ID/Investigator# 12600

Colorado Springs, Colorado, 80909, United States

Location

Site Reference ID/Investigator# 12679

Waterbury, Connecticut, 06708, United States

Location

Site Reference ID/Investigator# 12598

Clearwater, Florida, 33756, United States

Location

Site Reference ID/Investigator# 15542

Coral Gables, Florida, 33134, United States

Location

Site Reference ID/Investigator# 12477

Daytona Beach, Florida, 32117, United States

Location

Site Reference ID/Investigator# 12668

Delray Beach, Florida, 33484, United States

Location

Site Reference ID/Investigator# 15483

Fort Lauderdale, Florida, 33306, United States

Location

Site Reference ID/Investigator# 12645

Fort Myers, Florida, 33907, United States

Location

Site Reference ID/Investigator# 12672

Hollywood, Florida, 33023, United States

Location

Site Reference ID/Investigator# 17504

Jacksonville, Florida, 32205, United States

Location

Site Reference ID/Investigator# 12781

Jacksonville, Florida, 32259, United States

Location

Site Reference ID/Investigator# 12665

Jupiter, Florida, 33458-7200, United States

Location

Site Reference ID/Investigator# 12682

Longwood, Florida, 32779, United States

Location

Site Reference ID/Investigator# 15486

Melbourne, Florida, 32935, United States

Location

Site Reference ID/Investigator# 12502

New Port Richey, Florida, 34652, United States

Location

Site Reference ID/Investigator# 12647

Ocala, Florida, 34471, United States

Location

Site Reference ID/Investigator# 12520

Orlando, Florida, 32806, United States

Location

Site Reference ID/Investigator# 12687

Ormond Beach, Florida, 32174, United States

Location

Site Reference ID/Investigator# 12583

Sarasota, Florida, 34233, United States

Location

Site Reference ID/Investigator# 12652

Tampa, Florida, 33607, United States

Location

Site Reference ID/Investigator# 12557

West Palm Beach, Florida, 33401, United States

Location

Site Reference ID/Investigator# 12621

Winter Haven, Florida, 33880, United States

Location

Site Reference ID/Investigator# 16505

Winter Park, Florida, 32792, United States

Location

Site Reference ID/Investigator# 12675

Augusta, Georgia, 30909, United States

Location

Site Reference ID/Investigator# 12620

Dunwoody, Georgia, 30338, United States

Location

Site Reference ID/Investigator# 12653

Roswell, Georgia, 30076, United States

Location

Site Reference ID/Investigator# 12555

Suwanee, Georgia, 30024, United States

Location

Site Reference ID/Investigator# 12787

Woodstock, Georgia, 30189, United States

Location

Site Reference ID/Investigator# 12514

Chicago, Illinois, 60654, United States

Location

Site Reference ID/Investigator# 12487

Peoria, Illinois, 61602, United States

Location

Site Reference ID/Investigator# 12627

Peoria, Illinois, 61614, United States

Location

Site Reference ID/Investigator# 12529

Evansville, Indiana, 47714, United States

Location

Site Reference ID/Investigator# 12688

Indianapolis, Indiana, 46260, United States

Location

Site Reference ID/Investigator# 15485

South Bend, Indiana, 46601, United States

Location

Site Reference ID/Investigator# 12676

Arkansas City, Kansas, 67005, United States

Location

Site Reference ID/Investigator# 12597

Wichita, Kansas, 67203, United States

Location

Site Reference ID/Investigator# 12472

Louisville, Kentucky, 40213, United States

Location

Site Reference ID/Investigator# 12658

Mount Sterling, Kentucky, 40353, United States

Location

Site Reference ID/Investigator# 12586

Baltimore, Maryland, 21209, United States

Location

Site Reference ID/Investigator# 12480

Bethesda, Maryland, 20817, United States

Location

Site Reference ID/Investigator# 12638

Oxon Hill, Maryland, 20745, United States

Location

Site Reference ID/Investigator# 12513

Springfield, Massachusetts, 01103, United States

Location

Site Reference ID/Investigator# 12663

Kalamazoo, Michigan, 49009, United States

Location

Site Reference ID/Investigator# 12609

Brooklyn Center, Minnesota, 55430, United States

Location

Site Reference ID/Investigator# 16622

Edina, Minnesota, 55435, United States

Location

Site Reference ID/Investigator# 12625

Jackson, Mississippi, 39202, United States

Location

Site Reference ID/Investigator# 12560

Olive Branch, Mississippi, 38654, United States

Location

Site Reference ID/Investigator# 12534

City of Saint Peters, Missouri, 63376, United States

Location

Site Reference ID/Investigator# 12677

St Louis, Missouri, 63141, United States

Location

Site Reference ID/Investigator# 12592

Billings, Montana, 59101, United States

Location

Site Reference ID/Investigator# 12655

Omaha, Nebraska, 68131, United States

Location

Site Reference ID/Investigator# 12587

Las Vegas, Nevada, 89123, United States

Location

Site Reference ID/Investigator# 12554

Berlin, New Jersey, 08009, United States

Location

Site Reference ID/Investigator# 12637

Elizabeth, New Jersey, 07202, United States

Location

Site Reference ID/Investigator# 12463

Hillsborough, New Jersey, 08844, United States

Location

Site Reference ID/Investigator# 12660

Trenton, New Jersey, 08611, United States

Location

Site Reference ID/Investigator# 12506

Albuquerque, New Mexico, 87108, United States

Location

Site Reference ID/Investigator# 12539

Johnson City, New York, 13790, United States

Location

Site Reference ID/Investigator# 12631

Syracuse, New York, 13202, United States

Location

Site Reference ID/Investigator# 17503

Cary, North Carolina, 27518, United States

Location

Site Reference ID/Investigator# 12650

Charlotte, North Carolina, 28209, United States

Location

Site Reference ID/Investigator# 12504

Charlotte, North Carolina, 28211, United States

Location

Site Reference ID/Investigator# 12558

Charlotte, North Carolina, 28262, United States

Location

Site Reference ID/Investigator# 12671

Charlotte, North Carolina, 28277, United States

Location

Site Reference ID/Investigator# 12527

Hickory, North Carolina, 28601, United States

Location

Site Reference ID/Investigator# 12608

Morehead City, North Carolina, 28557, United States

Location

Site Reference ID/Investigator# 12535

Salisbury, North Carolina, 28144, United States

Location

Site Reference ID/Investigator# 12656

Statesville, North Carolina, 28677, United States

Location

Site Reference ID/Investigator# 17641

Wilmington, North Carolina, 28401, United States

Location

Site Reference ID/Investigator# 12606

Winston-Salem, North Carolina, 27103, United States

Location

Site Reference ID/Investigator# 12614

Akron, Ohio, 44311, United States

Location

Site Reference ID/Investigator# 12662

Cincinnati, Ohio, 45219, United States

Location

Site Reference ID/Investigator# 12545

Cincinnati, Ohio, 45242, United States

Location

Site Reference ID/Investigator# 12640

Kettering, Ohio, 45429, United States

Location

Site Reference ID/Investigator# 12786

Mason, Ohio, 45040, United States

Location

Site Reference ID/Investigator# 12630

Warren, Ohio, 44483, United States

Location

Site Reference ID/Investigator# 12551

Oklahoma City, Oklahoma, 73112, United States

Location

Site Reference ID/Investigator# 12611

Tulsa, Oklahoma, 74136, United States

Location

Site Reference ID/Investigator# 12585

Medford, Oregon, 97504, United States

Location

Site Reference ID/Investigator# 12610

Beaver, Pennsylvania, 15009, United States

Location

Site Reference ID/Investigator# 12589

Duncansville, Pennsylvania, 16635, United States

Location

Site Reference ID/Investigator# 12607

Harleysville, Pennsylvania, 19438-2513, United States

Location

Site Reference ID/Investigator# 12641

Jersey Shore, Pennsylvania, 17740, United States

Location

Site Reference ID/Investigator# 12507

Melrose Park, Pennsylvania, 19027, United States

Location

Site Reference ID/Investigator# 12624

Perkasie, Pennsylvania, 18944, United States

Location

Site Reference ID/Investigator# 12669

Philadelphia, Pennsylvania, 19114, United States

Location

Site Reference ID/Investigator# 12788

Philadelphia, Pennsylvania, 19152, United States

Location

Site Reference ID/Investigator# 12525

Pittsburgh, Pennsylvania, 15216, United States

Location

Site Reference ID/Investigator# 12601

Tipton, Pennsylvania, 16684, United States

Location

Site Reference ID/Investigator# 12686

Warminster, Pennsylvania, 18974, United States

Location

Site Reference ID/Investigator# 12623

Mt. Pleasant, South Carolina, 29464, United States

Location

Site Reference ID/Investigator# 12681

Mt. Pleasant, South Carolina, 29464, United States

Location

Site Reference ID/Investigator# 12485

Simpsonville, South Carolina, 29681, United States

Location

Site Reference ID/Investigator# 12639

Summerville, South Carolina, 29485, United States

Location

Site Reference ID/Investigator# 15642

Germantown, Tennessee, 38138, United States

Location

Site Reference ID/Investigator# 12643

Jackson, Tennessee, 38305, United States

Location

Site Reference ID/Investigator# 12470

Dallas, Texas, 75230, United States

Location

Site Reference ID/Investigator# 16081

Dallas, Texas, 75234, United States

Location

Site Reference ID/Investigator# 12492

Dallas, Texas, 75251, United States

Location

Site Reference ID/Investigator# 12464

Fort Worth, Texas, 76104, United States

Location

Site Reference ID/Investigator# 12646

San Antonio, Texas, 78205, United States

Location

Site Reference ID/Investigator# 16601

San Antonio, Texas, 78215, United States

Location

Site Reference ID/Investigator# 12540

San Antonio, Texas, 78224, United States

Location

Site Reference ID/Investigator# 12466

San Antonio, Texas, 78229, United States

Location

Site Reference ID/Investigator# 12622

San Antonio, Texas, 78229, United States

Location

Site Reference ID/Investigator# 12538

Norfolk, Virginia, 23502-9921, United States

Location

Site Reference ID/Investigator# 12616

Richmond, Virginia, 23294, United States

Location

Site Reference ID/Investigator# 12476

Madison, Wisconsin, 53719, United States

Location

Related Publications (1)

• 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.

  PMID: 20524719 DERIVED

MeSH Terms

Conditions

Dyslipidemias; Hypercholesterolemia; Hypertriglyceridemia

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

+44 1509 645 895

Study Officials

• Torbjörn Lundström, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 22, 2008
• Study Start: November 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 3, 2012
• Results First Posted: August 1, 2012

Record last verified: 2012-09

Locations

US (129)