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Dyslipidemia, Hypercholesterolemia, HypertriglyceridemiaPhase 3NCT00812955

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

A Phase 3 study testing ABT-143 and simvastatin in people with Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, run by AstraZeneca at 129 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ABT-143 and simvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
474 participants
Where
129 sitesUnited States
Study dates
Nov 2008to Jun 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

129 sites in 1 country.

129 sites in 1 country

United States129 sites

  • Site Reference ID/Investigator# 12614

    Akron, Ohio, 44311

  • Site Reference ID/Investigator# 12506

    Albuquerque, New Mexico, 87108

  • Site Reference ID/Investigator# 12489

    Anaheim, California, 92804

  • Site Reference ID/Investigator# 12676

    Arkansas City, Kansas, 67005

  • Site Reference ID/Investigator# 12675

    Augusta, Georgia, 30909

  • Site Reference ID/Investigator# 12586

    Baltimore, Maryland, 21209

  • Site Reference ID/Investigator# 12610

    Beaver, Pennsylvania, 15009

  • Site Reference ID/Investigator# 12554

    Berlin, New Jersey, 08009

  • Site Reference ID/Investigator# 12480

    Bethesda, Maryland, 20817

  • Site Reference ID/Investigator# 12592

    Billings, Montana, 59101

  • Site Reference ID/Investigator# 12654

    Birmingham, Alabama, 35235

  • Site Reference ID/Investigator# 12609

    Brooklyn Center, Minnesota, 55430

  • Site Reference ID/Investigator# 12495

    Carmichael, California, 95608

  • Site Reference ID/Investigator# 17503

    Cary, North Carolina, 27518

  • Site Reference ID/Investigator# 12673

    Chandler, Arizona, 85225

  • Site Reference ID/Investigator# 12650

    Charlotte, North Carolina, 28209

  • Site Reference ID/Investigator# 12504

    Charlotte, North Carolina, 28211

  • Site Reference ID/Investigator# 12558

    Charlotte, North Carolina, 28262

  • Site Reference ID/Investigator# 12671

    Charlotte, North Carolina, 28277

  • Site Reference ID/Investigator# 12514

    Chicago, Illinois, 60654

  • Site Reference ID/Investigator# 12467

    Chula Vista, California, 91911

  • Site Reference ID/Investigator# 12662

    Cincinnati, Ohio, 45219

  • Site Reference ID/Investigator# 12545

    Cincinnati, Ohio, 45242

  • Site Reference ID/Investigator# 12534

    City of Saint Peters, Missouri, 63376

  • Site Reference ID/Investigator# 12598

    Clearwater, Florida, 33756

  • Site Reference ID/Investigator# 12461

    Colorado Springs, Colorado, 80904

  • Site Reference ID/Investigator# 12600

    Colorado Springs, Colorado, 80909

  • Site Reference ID/Investigator# 12634

    Columbiana, Alabama, 35051

  • Site Reference ID/Investigator# 15542

    Coral Gables, Florida, 33134

  • Site Reference ID/Investigator# 12470

    Dallas, Texas, 75230

  • Site Reference ID/Investigator# 16081

    Dallas, Texas, 75234

  • Site Reference ID/Investigator# 12492

    Dallas, Texas, 75251

  • Site Reference ID/Investigator# 12477

    Daytona Beach, Florida, 32117

  • Site Reference ID/Investigator# 12668

    Delray Beach, Florida, 33484

  • Site Reference ID/Investigator# 12589

    Duncansville, Pennsylvania, 16635

  • Site Reference ID/Investigator# 12620

    Dunwoody, Georgia, 30338

  • Site Reference ID/Investigator# 16622

    Edina, Minnesota, 55435

  • Site Reference ID/Investigator# 12637

    Elizabeth, New Jersey, 07202

  • Site Reference ID/Investigator# 12529

    Evansville, Indiana, 47714

  • Site Reference ID/Investigator# 15483

    Fort Lauderdale, Florida, 33306

  • Site Reference ID/Investigator# 12645

    Fort Myers, Florida, 33907

  • Site Reference ID/Investigator# 12464

    Fort Worth, Texas, 76104

  • Site Reference ID/Investigator# 15642

    Germantown, Tennessee, 38138

  • Site Reference ID/Investigator# 12607

    Harleysville, Pennsylvania, 19438-2513

  • Site Reference ID/Investigator# 12527

    Hickory, North Carolina, 28601

  • Site Reference ID/Investigator# 12463

    Hillsborough, New Jersey, 08844

  • Site Reference ID/Investigator# 12672

    Hollywood, Florida, 33023

  • Site Reference ID/Investigator# 12559

    Huntsville, Alabama, 35801

  • Site Reference ID/Investigator# 12688

    Indianapolis, Indiana, 46260

  • Site Reference ID/Investigator# 12625

    Jackson, Mississippi, 39202

  • Site Reference ID/Investigator# 12643

    Jackson, Tennessee, 38305

  • Site Reference ID/Investigator# 17504

    Jacksonville, Florida, 32205

  • Site Reference ID/Investigator# 12781

    Jacksonville, Florida, 32259

  • Site Reference ID/Investigator# 12641

    Jersey Shore, Pennsylvania, 17740

  • Site Reference ID/Investigator# 12539

    Johnson City, New York, 13790

  • Site Reference ID/Investigator# 12665

    Jupiter, Florida, 33458-7200

  • Site Reference ID/Investigator# 12663

    Kalamazoo, Michigan, 49009

  • Site Reference ID/Investigator# 12640

    Kettering, Ohio, 45429

  • Site Reference ID/Investigator# 12587

    Las Vegas, Nevada, 89123

  • Site Reference ID/Investigator# 12657

    Little Rock, Arkansas, 72204

  • Site Reference ID/Investigator# 12498

    Long Beach, California, 90806

  • Site Reference ID/Investigator# 12682

    Longwood, Florida, 32779

  • Site Reference ID/Investigator# 12602

    Los Angeles, California, 90057

  • Site Reference ID/Investigator# 12472

    Louisville, Kentucky, 40213

  • Site Reference ID/Investigator# 12476

    Madison, Wisconsin, 53719

  • Site Reference ID/Investigator# 12786

    Mason, Ohio, 45040

  • Site Reference ID/Investigator# 12585

    Medford, Oregon, 97504

  • Site Reference ID/Investigator# 15486

    Melbourne, Florida, 32935

  • Site Reference ID/Investigator# 12507

    Melrose Park, Pennsylvania, 19027

  • Site Reference ID/Investigator# 12608

    Morehead City, North Carolina, 28557

  • Site Reference ID/Investigator# 12658

    Mount Sterling, Kentucky, 40353

  • Site Reference ID/Investigator# 12623

    Mt. Pleasant, South Carolina, 29464

  • Site Reference ID/Investigator# 12681

    Mt. Pleasant, South Carolina, 29464

  • Site Reference ID/Investigator# 12502

    New Port Richey, Florida, 34652

  • Site Reference ID/Investigator# 12538

    Norfolk, Virginia, 23502-9921

  • Site Reference ID/Investigator# 12510

    Norwalk, California, 90650

  • Site Reference ID/Investigator# 12647

    Ocala, Florida, 34471

  • Site Reference ID/Investigator# 12551

    Oklahoma City, Oklahoma, 73112

  • Site Reference ID/Investigator# 12560

    Olive Branch, Mississippi, 38654

  • Site Reference ID/Investigator# 12655

    Omaha, Nebraska, 68131

  • Site Reference ID/Investigator# 12520

    Orlando, Florida, 32806

  • Site Reference ID/Investigator# 12687

    Ormond Beach, Florida, 32174

  • Site Reference ID/Investigator# 12638

    Oxon Hill, Maryland, 20745

  • Site Reference ID/Investigator# 12499

    Ozark, Alabama, 36360

  • Site Reference ID/Investigator# 12550

    Palm Desert, California, 92260

  • Site Reference ID/Investigator# 12487

    Peoria, Illinois, 61602

  • Site Reference ID/Investigator# 12627

    Peoria, Illinois, 61614

  • Site Reference ID/Investigator# 12624

    Perkasie, Pennsylvania, 18944

  • Site Reference ID/Investigator# 12669

    Philadelphia, Pennsylvania, 19114

  • Site Reference ID/Investigator# 12788

    Philadelphia, Pennsylvania, 19152

  • Site Reference ID/Investigator# 12525

    Pittsburgh, Pennsylvania, 15216

  • Site Reference ID/Investigator# 12616

    Richmond, Virginia, 23294

  • Site Reference ID/Investigator# 16503

    Roseville, California, 95661

  • Site Reference ID/Investigator# 12653

    Roswell, Georgia, 30076

  • Site Reference ID/Investigator# 12678

    Sacramento, California, 95825

  • Site Reference ID/Investigator# 14241

    Sacramento, California, 95825

  • Site Reference ID/Investigator# 12535

    Salisbury, North Carolina, 28144

  • Site Reference ID/Investigator# 12646

    San Antonio, Texas, 78205

  • Site Reference ID/Investigator# 16601

    San Antonio, Texas, 78215

  • Site Reference ID/Investigator# 12540

    San Antonio, Texas, 78224

  • Site Reference ID/Investigator# 12466

    San Antonio, Texas, 78229

  • Site Reference ID/Investigator# 12622

    San Antonio, Texas, 78229

  • Site Reference ID/Investigator# 12473

    San Diego, California, 92123

  • Site Reference ID/Investigator# 12583

    Sarasota, Florida, 34233

  • Site Reference ID/Investigator# 17282

    Scottsdale, Arizona, 85251

  • Site Reference ID/Investigator# 12485

    Simpsonville, South Carolina, 29681

  • Site Reference ID/Investigator# 15485

    South Bend, Indiana, 46601

  • Site Reference ID/Investigator# 12513

    Springfield, Massachusetts, 01103

  • Site Reference ID/Investigator# 12677

    St Louis, Missouri, 63141

  • Site Reference ID/Investigator# 12656

    Statesville, North Carolina, 28677

  • Site Reference ID/Investigator# 12639

    Summerville, South Carolina, 29485

  • Site Reference ID/Investigator# 12555

    Suwanee, Georgia, 30024

  • Site Reference ID/Investigator# 12631

    Syracuse, New York, 13202

  • Site Reference ID/Investigator# 12652

    Tampa, Florida, 33607

  • Site Reference ID/Investigator# 12601

    Tipton, Pennsylvania, 16684

  • Site Reference ID/Investigator# 12660

    Trenton, New Jersey, 08611

  • Site Reference ID/Investigator# 12611

    Tulsa, Oklahoma, 74136

  • Site Reference ID/Investigator# 12497

    Walnut Creek, California, 94598

  • Site Reference ID/Investigator# 12686

    Warminster, Pennsylvania, 18974

  • Site Reference ID/Investigator# 12630

    Warren, Ohio, 44483

  • Site Reference ID/Investigator# 12679

    Waterbury, Connecticut, 06708

  • Site Reference ID/Investigator# 12680

    West Hills, California, 91307

  • Site Reference ID/Investigator# 12557

    West Palm Beach, Florida, 33401

  • Site Reference ID/Investigator# 12597

    Wichita, Kansas, 67203

  • Site Reference ID/Investigator# 17641

    Wilmington, North Carolina, 28401

  • Site Reference ID/Investigator# 12606

    Winston-Salem, North Carolina, 27103

  • Site Reference ID/Investigator# 12621

    Winter Haven, Florida, 33880

  • Site Reference ID/Investigator# 16505

    Winter Park, Florida, 32792

  • Site Reference ID/Investigator# 12787

    Woodstock, Georgia, 30189

Other trials in United States

About this study

Official title: An 8-Week, Multicenter, Randomized, Double-blind, Four-arm, Parallel-group Study Comparing the Safety and Efficacy of ABT-143 to Simvastatin in Subjects With Hypercholesterolemia

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.

Read the detailed description

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.

Being tested
ABT-143, simvastatin
Keywords
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia
Medical subject headings
Dyslipidemias, Hypercholesterolemia, Hypertriglyceridemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABT-143Drug

    Once daily for 8 weeks

  • simvastatinDrug

    Once daily for 8 weeks simvastatin capsules 40 mg

Study groups in NCT00812955
Study groupRoleWhat they receive
A - ABT-143 capsules 5/135 mgExperimentalABT-143 capsules 5/135 mg - ABT-143 (rosuvastatin 5 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks
Receives: Drug: ABT-143
B - ABT-143 capsules 10/135 mgExperimentalABT-143 capsules 10/135 mg - ABT-143 (rosuvastatin 10 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks
Receives: Drug: ABT-143
C - ABT-143 capsules 20/135 mgExperimentalABT-143 capsules 20/135 mg - ABT-143 (rosuvastatin 20 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks
Receives: Drug: ABT-143
D - Simvastatin capsules 40 mgActive comparatorSimvastatin capsules 40 mg daily for 8 weeks
Receives: Drug: simvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to 8 weeks

Secondary outcomes (2)

  1. 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)

    The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 10/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.

    Measured: Baseline to 8 weeks

  2. 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)

    The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 5/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.

    Measured: Baseline to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
474 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00812955
Sponsor's protocol ID
M10-667
Status last verified
Sep 2012
First submitted
18 Dec 2008
Last updated
3 Oct 2012
Data monitoring committee
No

Publications

  • 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.

    PubMed 20524719

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABT-143 and simvastatin in people with Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, run by AstraZeneca at 129 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00812955, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2012.

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