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A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects With Dyslipidemia

NCT ID: NCT00463606

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

760 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-02-29

Brief Summary

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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

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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).

Conditions

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Hypercholesterolemia Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ABT-335 and Rosuvastatin Calcium

ABT-335 135mg in combination with rosuvastatin calcium 5mg administered orally, once daily for 12 weeks

Group Type EXPERIMENTAL

ABT-335 and rosuvastatin calcium

Intervention Type DRUG

ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks

ABT-335

ABT-335 135mg monotherapy administered orally, once daily for 12 weeks

Group Type ACTIVE_COMPARATOR

ABT-335

Intervention Type DRUG

ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks

Rosuvastatin Calcium

Rosuvastatin calcium 5mg monotherapy administered orally, once daily for 12 weeks

Group Type ACTIVE_COMPARATOR

rosuvastatin calcium

Intervention Type DRUG

Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks

Interventions

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ABT-335 and rosuvastatin calcium

ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks

Intervention Type DRUG

ABT-335

ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks

Intervention Type DRUG

rosuvastatin calcium

Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks

Intervention Type DRUG

Other Intervention Names

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ABT-335 / Rosuvastatin Combination (ABT-143) fenofibric acid Rosuvastatin

Eligibility Criteria

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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.
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# 5469

Birmingham, Alabama, United States

Site Status

Site Reference ID/Investigator# 4428

Birmingham, Alabama, United States

Site Status

Site Reference ID/Investigator# 4985

Birmingham, Alabama, United States

Site Status

Site Reference ID/Investigator# 4493

Huntsville, Alabama, United States

Site Status

Site Reference ID/Investigator# 4510

Huntsville, Alabama, United States

Site Status

Site Reference ID/Investigator# 4431

Ozark, Alabama, United States

Site Status

Site Reference ID/Investigator# 4519

Tuscaloosa, Alabama, United States

Site Status

Site Reference ID/Investigator# 4395

Chandler, Arizona, United States

Site Status

Site Reference ID/Investigator# 4483

Gilbert, Arizona, United States

Site Status

Site Reference ID/Investigator# 4411

Scottsdale, Arizona, United States

Site Status

Site Reference ID/Investigator# 4417

Little Rock, Arkansas, United States

Site Status

Site Reference ID/Investigator# 4702

Anaheim, California, United States

Site Status

Site Reference ID/Investigator# 5593

Chula Vista, California, United States

Site Status

Site Reference ID/Investigator# 4503

Concord, California, United States

Site Status

Site Reference ID/Investigator# 4530

Encinitas, California, United States

Site Status

Site Reference ID/Investigator# 4458

Fair Oaks, California, United States

Site Status

Site Reference ID/Investigator# 4542

Fresno, California, United States

Site Status

Site Reference ID/Investigator# 4574

Fresno, California, United States

Site Status

Site Reference ID/Investigator# 4441

Lincoln, California, United States

Site Status

Site Reference ID/Investigator# 4432

Long Beach, California, United States

Site Status

Site Reference ID/Investigator# 5579

Los Angeles, California, United States

Site Status

Site Reference ID/Investigator# 4980

Norwalk, California, United States

Site Status

Site Reference ID/Investigator# 4392

Sacramento, California, United States

Site Status

Site Reference ID/Investigator# 4896

Sacramento, California, United States

Site Status

Site Reference ID/Investigator# 5582

San Diego, California, United States

Site Status

Site Reference ID/Investigator# 6236

West Hills, California, United States

Site Status

Site Reference ID/Investigator# 4442

Aurora, Colorado, United States

Site Status

Site Reference ID/Investigator# 4419

Colorado Springs, Colorado, United States

Site Status

Site Reference ID/Investigator# 4391

Waterbury, Connecticut, United States

Site Status

Site Reference ID/Investigator# 4401

Coral Gables, Florida, United States

Site Status

Site Reference ID/Investigator# 4453

Fort Lauderdale, Florida, United States

Site Status

Site Reference ID/Investigator# 4490

Holly Hill, Florida, United States

Site Status

Site Reference ID/Investigator# 4420

Hollywood, Florida, United States

Site Status

Site Reference ID/Investigator# 5011

Jacksonville, Florida, United States

Site Status

Site Reference ID/Investigator# 4444

Jacksonville, Florida, United States

Site Status

Site Reference ID/Investigator# 4399

Jupiter, Florida, United States

Site Status

Site Reference ID/Investigator# 4433

Kissimmee, Florida, United States

Site Status

Site Reference ID/Investigator# 4469

Largo, Florida, United States

Site Status

Site Reference ID/Investigator# 4525

Melbourne, Florida, United States

Site Status

Site Reference ID/Investigator# 4477

Miami, Florida, United States

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Site Reference ID/Investigator# 4430

New Port Richey, Florida, United States

Site Status

Site Reference ID/Investigator# 4409

New Smyrna Beach, Florida, United States

Site Status

Site Reference ID/Investigator# 4416

Ocala, Florida, United States

Site Status

Site Reference ID/Investigator# 4528

Ocala, Florida, United States

Site Status

Site Reference ID/Investigator# 5103

Orlando, Florida, United States

Site Status

Site Reference ID/Investigator# 4446

Ormond Beach, Florida, United States

Site Status

Site Reference ID/Investigator# 4524

Pensacola, Florida, United States

Site Status

Site Reference ID/Investigator# 4505

Sarasota, Florida, United States

Site Status

Site Reference ID/Investigator# 5580

Sarasota, Florida, United States

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Site Reference ID/Investigator# 4494

West Palm Beach, Florida, United States

Site Status

Site Reference ID/Investigator# 4407

West Palm Beach, Florida, United States

Site Status

Site Reference ID/Investigator# 4512

Winter Haven, Florida, United States

Site Status

Site Reference ID/Investigator# 5478

Blue Ridge, Georgia, United States

Site Status

Site Reference ID/Investigator# 4388

Decatur, Georgia, United States

Site Status

Site Reference ID/Investigator# 4511

Dunwoody, Georgia, United States

Site Status

Site Reference ID/Investigator# 4981

Roswell, Georgia, United States

Site Status

Site Reference ID/Investigator# 4448

Roswell, Georgia, United States

Site Status

Site Reference ID/Investigator# 4497

Suwanee, Georgia, United States

Site Status

Site Reference ID/Investigator# 4439

Woodstock, Georgia, United States

Site Status

Site Reference ID/Investigator# 4472

Arlington Heights, Illinois, United States

Site Status

Site Reference ID/Investigator# 5585

Chicago, Illinois, United States

Site Status

Site Reference ID/Investigator# 4520

Peoria, Illinois, United States

Site Status

Site Reference ID/Investigator# 4527

Avon, Indiana, United States

Site Status

Site Reference ID/Investigator# 4485

Evansville, Indiana, United States

Site Status

Site Reference ID/Investigator# 4445

Indianapolis, Indiana, United States

Site Status

Site Reference ID/Investigator# 4438

Lafayette, Indiana, United States

Site Status

Site Reference ID/Investigator# 5010

Newburgh, Indiana, United States

Site Status

Site Reference ID/Investigator# 4403

Iowa City, Iowa, United States

Site Status

Site Reference ID/Investigator# 4393

Arkansas City, Kansas, United States

Site Status

Site Reference ID/Investigator# 4526

Overland Park, Kansas, United States

Site Status

Site Reference ID/Investigator# 4423

Wichita, Kansas, United States

Site Status

Site Reference ID/Investigator# 4424

Wichita, Kansas, United States

Site Status

Site Reference ID/Investigator# 5027

Lexington, Kentucky, United States

Site Status

Site Reference ID/Investigator# 4471

Louisville, Kentucky, United States

Site Status

Site Reference ID/Investigator# 4406

New Orleans, Louisiana, United States

Site Status

Site Reference ID/Investigator# 4509

Slidell, Louisiana, United States

Site Status

Site Reference ID/Investigator# 5635

Auburn, Maine, United States

Site Status

Site Reference ID/Investigator# 4502

Scarborough, Maine, United States

Site Status

Site Reference ID/Investigator# 5070

Baltimore, Maryland, United States

Site Status

Site Reference ID/Investigator# 4412

Haverhill, Massachusetts, United States

Site Status

Site Reference ID/Investigator# 4487

Springfield, Massachusetts, United States

Site Status

Site Reference ID/Investigator# 5533

Ann Arbor, Michigan, United States

Site Status

Site Reference ID/Investigator# 6237

Ann Arbor, Michigan, United States

Site Status

Site Reference ID/Investigator# 5583

Portage, Michigan, United States

Site Status

Site Reference ID/Investigator# 4480

Brooklyn Center, Minnesota, United States

Site Status

Site Reference ID/Investigator# 4515

Jackson, Mississippi, United States

Site Status

Site Reference ID/Investigator# 4492

Olive Branch, Mississippi, United States

Site Status

Site Reference ID/Investigator# 5636

Tupelo, Mississippi, United States

Site Status

Site Reference ID/Investigator# 4499

City of Saint Peters, Missouri, United States

Site Status

Site Reference ID/Investigator# 4500

Kansas City, Missouri, United States

Site Status

Site Reference ID/Investigator# 4979

Billings, Montana, United States

Site Status

Site Reference ID/Investigator# 4481

Missoula, Montana, United States

Site Status

Site Reference ID/Investigator# 4460

Las Vegas, Nevada, United States

Site Status

Site Reference ID/Investigator# 4466

Las Vegas, Nevada, United States

Site Status

Site Reference ID/Investigator# 5484

Las Vegas, Nevada, United States

Site Status

Site Reference ID/Investigator# 5444

Concord, New Hampshire, United States

Site Status

Site Reference ID/Investigator# 4908

Elizabeth, New Jersey, United States

Site Status

Site Reference ID/Investigator# 4504

South Bound Brook, New Jersey, United States

Site Status

Site Reference ID/Investigator# 4394

Toms River, New Jersey, United States

Site Status

Site Reference ID/Investigator# 4402

Trenton, New Jersey, United States

Site Status

Site Reference ID/Investigator# 4427

Albuquerque, New Mexico, United States

Site Status

Site Reference ID/Investigator# 4463

Bronxville, New York, United States

Site Status

Site Reference ID/Investigator# 4415

New York, New York, United States

Site Status

Site Reference ID/Investigator# 4440

Rochester, New York, United States

Site Status

Site Reference ID/Investigator# 4464

Syracuse, New York, United States

Site Status

Site Reference ID/Investigator# 4425

Williamsville, New York, United States

Site Status

Site Reference ID/Investigator# 4473

Asheville, North Carolina, United States

Site Status

Site Reference ID/Investigator# 4531

Charlotte, North Carolina, United States

Site Status

Site Reference ID/Investigator# 4396

Charlotte, North Carolina, United States

Site Status

Site Reference ID/Investigator# 5494

Hickory, North Carolina, United States

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Site Reference ID/Investigator# 4479

Morehead City, North Carolina, United States

Site Status

Site Reference ID/Investigator# 4461

Raleigh, North Carolina, United States

Site Status

Site Reference ID/Investigator# 4498

Salisbury, North Carolina, United States

Site Status

Site Reference ID/Investigator# 4405

Statesville, North Carolina, United States

Site Status

Site Reference ID/Investigator# 4476

Winston-Salem, North Carolina, United States

Site Status

Site Reference ID/Investigator# 4390

Cincinnati, Ohio, United States

Site Status

Site Reference ID/Investigator# 4400

Cincinnati, Ohio, United States

Site Status

Site Reference ID/Investigator# 4501

Cincinnati, Ohio, United States

Site Status

Site Reference ID/Investigator# 4517

Cincinnati, Ohio, United States

Site Status

Site Reference ID/Investigator# 5584

Columbus, Ohio, United States

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Site Reference ID/Investigator# 4410

Mogadore, Ohio, United States

Site Status

Site Reference ID/Investigator# 4443

Sandusky, Ohio, United States

Site Status

Site Reference ID/Investigator# 4523

Warren, Ohio, United States

Site Status

Site Reference ID/Investigator# 4488

Oklahoma City, Oklahoma, United States

Site Status

Site Reference ID/Investigator# 4451

Oklahoma City, Oklahoma, United States

Site Status

Site Reference ID/Investigator# 4422

Tulsa, Oklahoma, United States

Site Status

Site Reference ID/Investigator# 4482

Tulsa, Oklahoma, United States

Site Status

Site Reference ID/Investigator# 4467

Medford, Oregon, United States

Site Status

Site Reference ID/Investigator# 4470

Carlisle, Pennsylvania, United States

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Site Reference ID/Investigator# 5581

Downingtown, Pennsylvania, United States

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Site Reference ID/Investigator# 4434

Feasterville, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 4478

Harleysville, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 4436

Jersey Shore, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 4397

Lansdale, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 4426

Melrose Park, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 4894

Newtown, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 4496

Penndel, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 4404

Philadelphia, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 4437

Philadelphia, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 4387

Philadelphia, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 4447

Warminster, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 4506

Charleston, South Carolina, United States

Site Status

Site Reference ID/Investigator# 5443

Greenville, South Carolina, United States

Site Status

Site Reference ID/Investigator# 4484

Greer, South Carolina, United States

Site Status

Site Reference ID/Investigator# 4455

Moncks Corner, South Carolina, United States

Site Status

Site Reference ID/Investigator# 4513

Mt. Pleasant, South Carolina, United States

Site Status

Site Reference ID/Investigator# 4521

Simpsonville, South Carolina, United States

Site Status

Site Reference ID/Investigator# 4982

Summerville, South Carolina, United States

Site Status

Site Reference ID/Investigator# 5586

Sioux Falls, South Dakota, United States

Site Status

Site Reference ID/Investigator# 4435

Jackson, Tennessee, United States

Site Status

Site Reference ID/Investigator# 4454

Johnson City, Tennessee, United States

Site Status

Site Reference ID/Investigator# 4529

Nashville, Tennessee, United States

Site Status

Site Reference ID/Investigator# 5454

Arlington, Texas, United States

Site Status

Site Reference ID/Investigator# 5578

Houston, Texas, United States

Site Status

Site Reference ID/Investigator# 5669

Houston, Texas, United States

Site Status

Site Reference ID/Investigator# 4893

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 4429

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 4457

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 4465

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 4508

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 4892

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 5948

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 4413

Temple, Texas, United States

Site Status

Site Reference ID/Investigator# 4456

Falls Church, Virginia, United States

Site Status

Site Reference ID/Investigator# 4459

Richmond, Virginia, United States

Site Status

Site Reference ID/Investigator# 4408

Richmond, Virginia, United States

Site Status

Site Reference ID/Investigator# 4421

Lakewood, Washington, United States

Site Status

Site Reference ID/Investigator# 4468

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21174145 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20953684 (View on PubMed)

Other Identifiers

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M06-844

Identifier Type: -

Identifier Source: org_study_id