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

NCT00463606 | Completed Phase 3 Results

• 1 other identifier: M06-844
• Study Type: interventional
• Target: 760
• Locations: 1 country
• Sites: 168

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.

Conditions

Hypercholesterolemia; Dyslipidemia

Outcome Measures

Primary Outcomes (3)

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

  The mean percent change from baseline to the final visit in High-density lipoprotein cholesterol (HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.

  Baseline to 12 Weeks

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

  The mean percent change from baseline to the final visit in triglycerides, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.

  Baseline to 12 Weeks

• 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 (LDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.

  Baseline to 12 Weeks

Secondary Outcomes (6)

• 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)

  Baseline to 12 Weeks

• 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)

  Baseline to 12 Weeks

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

  Baseline to 12 Weeks

• Mean Percent Change From Baseline to the Final Visit in Apolipoprotein B (ApoB) (Full Analysis Set)

  Baseline to 12 Weeks

• Median Percent Change From Baseline to the Final Visit in High Sensitivity C-reactive Protein (hsCRP) (Full Analysis Set)

  Baseline to 12 Weeks

Study Arms (3)

ABT-335 and Rosuvastatin Calcium

EXPERIMENTAL

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

Drug: ABT-335 and rosuvastatin calcium

ABT-335

ACTIVE COMPARATOR

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

Drug: ABT-335

Rosuvastatin Calcium

ACTIVE COMPARATOR

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

Drug: rosuvastatin calcium

Interventions

ABT-335 and rosuvastatin calcium DRUG

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

Also known as: ABT-335 / Rosuvastatin Combination (ABT-143)

ABT-335 and Rosuvastatin Calcium

ABT-335 DRUG

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

Also known as: fenofibric acid

ABT-335

rosuvastatin calcium DRUG

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

Also known as: Rosuvastatin

Rosuvastatin Calcium

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (168)

Site Reference ID/Investigator# 5469

Birmingham, Alabama, 35205, United States

Location

Site Reference ID/Investigator# 4428

Birmingham, Alabama, 35209-6802, United States

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Site Reference ID/Investigator# 4985

Birmingham, Alabama, 35235, United States

Location

Site Reference ID/Investigator# 4493

Huntsville, Alabama, 35801, United States

Location

Site Reference ID/Investigator# 4510

Huntsville, Alabama, 35802, United States

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Site Reference ID/Investigator# 4431

Ozark, Alabama, 36360, United States

Location

Site Reference ID/Investigator# 4519

Tuscaloosa, Alabama, 35406, United States

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Site Reference ID/Investigator# 4395

Chandler, Arizona, 85225, United States

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Site Reference ID/Investigator# 4483

Gilbert, Arizona, 85295, United States

Location

Site Reference ID/Investigator# 4411

Scottsdale, Arizona, 85251, United States

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Site Reference ID/Investigator# 4417

Little Rock, Arkansas, 72204, United States

Location

Site Reference ID/Investigator# 4702

Anaheim, California, 92804, United States

Location

Site Reference ID/Investigator# 5593

Chula Vista, California, 91911, United States

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Site Reference ID/Investigator# 4503

Concord, California, 94520, United States

Location

Site Reference ID/Investigator# 4530

Encinitas, California, 92024, United States

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Site Reference ID/Investigator# 4458

Fair Oaks, California, 95628, United States

Location

Site Reference ID/Investigator# 4542

Fresno, California, 93703, United States

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Site Reference ID/Investigator# 4574

Fresno, California, 93710, United States

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Site Reference ID/Investigator# 4441

Lincoln, California, 95648, United States

Location

Site Reference ID/Investigator# 4432

Long Beach, California, 90806, United States

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Site Reference ID/Investigator# 5579

Los Angeles, California, 90057, United States

Location

Site Reference ID/Investigator# 4980

Norwalk, California, 90650, United States

Location

Site Reference ID/Investigator# 4392

Sacramento, California, 95825, United States

Location

Site Reference ID/Investigator# 4896

Sacramento, California, 95825, United States

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Site Reference ID/Investigator# 5582

San Diego, California, 92128, United States

Location

Site Reference ID/Investigator# 6236

West Hills, California, 91307, United States

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Site Reference ID/Investigator# 4442

Aurora, Colorado, 80012, United States

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Site Reference ID/Investigator# 4419

Colorado Springs, Colorado, 80909, United States

Location

Site Reference ID/Investigator# 4391

Waterbury, Connecticut, 06708, United States

Location

Site Reference ID/Investigator# 4401

Coral Gables, Florida, 33134, United States

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Site Reference ID/Investigator# 4453

Fort Lauderdale, Florida, 33308, United States

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Site Reference ID/Investigator# 4490

Holly Hill, Florida, 32117, United States

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Site Reference ID/Investigator# 4420

Hollywood, Florida, 33021, United States

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Site Reference ID/Investigator# 5011

Jacksonville, Florida, 32216, United States

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Site Reference ID/Investigator# 4444

Jacksonville, Florida, 32259, United States

Location

Site Reference ID/Investigator# 4399

Jupiter, Florida, 33458-7200, United States

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Site Reference ID/Investigator# 4433

Kissimmee, Florida, 34741, United States

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Site Reference ID/Investigator# 4469

Largo, Florida, 33773, United States

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Site Reference ID/Investigator# 4525

Melbourne, Florida, 32935, United States

Location

Site Reference ID/Investigator# 4477

Miami, Florida, 33173, United States

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Site Reference ID/Investigator# 4430

New Port Richey, Florida, 34652, United States

Location

Site Reference ID/Investigator# 4409

New Smyrna Beach, Florida, 32168, United States

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Site Reference ID/Investigator# 4416

Ocala, Florida, 34471, United States

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Site Reference ID/Investigator# 4528

Ocala, Florida, 34471, United States

Location

Site Reference ID/Investigator# 5103

Orlando, Florida, 32806, United States

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Site Reference ID/Investigator# 4446

Ormond Beach, Florida, 32174, United States

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Site Reference ID/Investigator# 4524

Pensacola, Florida, 32514, United States

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Site Reference ID/Investigator# 4505

Sarasota, Florida, 34233, United States

Location

Site Reference ID/Investigator# 5580

Sarasota, Florida, 34239, United States

Location

Site Reference ID/Investigator# 4494

West Palm Beach, Florida, 33401, United States

Location

Site Reference ID/Investigator# 4407

West Palm Beach, Florida, 33407, United States

Location

Site Reference ID/Investigator# 4512

Winter Haven, Florida, 33880, United States

Location

Site Reference ID/Investigator# 5478

Blue Ridge, Georgia, 30513, United States

Location

Site Reference ID/Investigator# 4388

Decatur, Georgia, 30033, United States

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Site Reference ID/Investigator# 4511

Dunwoody, Georgia, 30338, United States

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Site Reference ID/Investigator# 4981

Roswell, Georgia, 30075, United States

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Site Reference ID/Investigator# 4448

Roswell, Georgia, 30076, United States

Location

Site Reference ID/Investigator# 4497

Suwanee, Georgia, 30024, United States

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Site Reference ID/Investigator# 4439

Woodstock, Georgia, 30189, United States

Location

Site Reference ID/Investigator# 4472

Arlington Heights, Illinois, 60004, United States

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Site Reference ID/Investigator# 5585

Chicago, Illinois, 60654, United States

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Site Reference ID/Investigator# 4520

Peoria, Illinois, 61602, United States

Location

Site Reference ID/Investigator# 4527

Avon, Indiana, 46123, United States

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Site Reference ID/Investigator# 4485

Evansville, Indiana, 47714, United States

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Site Reference ID/Investigator# 4445

Indianapolis, Indiana, 46260, United States

Location

Site Reference ID/Investigator# 4438

Lafayette, Indiana, 47904, United States

Location

Site Reference ID/Investigator# 5010

Newburgh, Indiana, 47630, United States

Location

Site Reference ID/Investigator# 4403

Iowa City, Iowa, 52242, United States

Location

Site Reference ID/Investigator# 4393

Arkansas City, Kansas, 67005, United States

Location

Site Reference ID/Investigator# 4526

Overland Park, Kansas, 66202, United States

Location

Site Reference ID/Investigator# 4423

Wichita, Kansas, 67203, United States

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Site Reference ID/Investigator# 4424

Wichita, Kansas, 67207, United States

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Site Reference ID/Investigator# 5027

Lexington, Kentucky, 40509, United States

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Site Reference ID/Investigator# 4471

Louisville, Kentucky, 40213, United States

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Site Reference ID/Investigator# 4406

New Orleans, Louisiana, 70112, United States

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Site Reference ID/Investigator# 4509

Slidell, Louisiana, 70458, United States

Location

Site Reference ID/Investigator# 5635

Auburn, Maine, 04210, United States

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Site Reference ID/Investigator# 4502

Scarborough, Maine, 04074, United States

Location

Site Reference ID/Investigator# 5070

Baltimore, Maryland, 21209, United States

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Site Reference ID/Investigator# 4412

Haverhill, Massachusetts, 01830, United States

Location

Site Reference ID/Investigator# 4487

Springfield, Massachusetts, 01103, United States

Location

Site Reference ID/Investigator# 5533

Ann Arbor, Michigan, 48106, United States

Location

Site Reference ID/Investigator# 6237

Ann Arbor, Michigan, 48106, United States

Location

Site Reference ID/Investigator# 5583

Portage, Michigan, 49024, United States

Location

Site Reference ID/Investigator# 4480

Brooklyn Center, Minnesota, 55430, United States

Location

Site Reference ID/Investigator# 4515

Jackson, Mississippi, 39202, United States

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Site Reference ID/Investigator# 4492

Olive Branch, Mississippi, 38654, United States

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Site Reference ID/Investigator# 5636

Tupelo, Mississippi, 38801, United States

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Site Reference ID/Investigator# 4499

City of Saint Peters, Missouri, 63376, United States

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Site Reference ID/Investigator# 4500

Kansas City, Missouri, 64114, United States

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Site Reference ID/Investigator# 4979

Billings, Montana, 59101, United States

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Site Reference ID/Investigator# 4481

Missoula, Montana, 59808, United States

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Site Reference ID/Investigator# 4460

Las Vegas, Nevada, 89102, United States

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Site Reference ID/Investigator# 4466

Las Vegas, Nevada, 89123, United States

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Site Reference ID/Investigator# 5484

Las Vegas, Nevada, 89146, United States

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Site Reference ID/Investigator# 5444

Concord, New Hampshire, 03301, United States

Location

Site Reference ID/Investigator# 4908

Elizabeth, New Jersey, 07202, United States

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Site Reference ID/Investigator# 4504

South Bound Brook, New Jersey, 08880, United States

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Site Reference ID/Investigator# 4394

Toms River, New Jersey, 08755, United States

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Site Reference ID/Investigator# 4402

Trenton, New Jersey, 08611, United States

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Site Reference ID/Investigator# 4427

Albuquerque, New Mexico, 87108, United States

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Site Reference ID/Investigator# 4463

Bronxville, New York, 10708, United States

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Site Reference ID/Investigator# 4415

New York, New York, 10021, United States

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Site Reference ID/Investigator# 4440

Rochester, New York, 14609, United States

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Site Reference ID/Investigator# 4464

Syracuse, New York, 13202, United States

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Site Reference ID/Investigator# 4425

Williamsville, New York, 14221, United States

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Site Reference ID/Investigator# 4473

Asheville, North Carolina, 28803, United States

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Site Reference ID/Investigator# 4531

Charlotte, North Carolina, 28209, United States

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Site Reference ID/Investigator# 4396

Charlotte, North Carolina, 28277, United States

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Site Reference ID/Investigator# 5494

Hickory, North Carolina, 28601, United States

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Site Reference ID/Investigator# 4479

Morehead City, North Carolina, 28557, United States

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Site Reference ID/Investigator# 4461

Raleigh, North Carolina, 27609, United States

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Site Reference ID/Investigator# 4498

Salisbury, North Carolina, 28144, United States

Location

Site Reference ID/Investigator# 4405

Statesville, North Carolina, 28677, United States

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Site Reference ID/Investigator# 4476

Winston-Salem, North Carolina, 27103, United States

Location

Site Reference ID/Investigator# 4390

Cincinnati, Ohio, 45212, United States

Location

Site Reference ID/Investigator# 4400

Cincinnati, Ohio, 45219, United States

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Site Reference ID/Investigator# 4501

Cincinnati, Ohio, 45219, United States

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Site Reference ID/Investigator# 4517

Cincinnati, Ohio, 45246, United States

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Site Reference ID/Investigator# 5584

Columbus, Ohio, 43212, United States

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Site Reference ID/Investigator# 4410

Mogadore, Ohio, 44260, United States

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Site Reference ID/Investigator# 4443

Sandusky, Ohio, 44870, United States

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Site Reference ID/Investigator# 4523

Warren, Ohio, 44483, United States

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Site Reference ID/Investigator# 4488

Oklahoma City, Oklahoma, 73103, United States

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Site Reference ID/Investigator# 4451

Oklahoma City, Oklahoma, 73112, United States

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Site Reference ID/Investigator# 4422

Tulsa, Oklahoma, 74104, United States

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Site Reference ID/Investigator# 4482

Tulsa, Oklahoma, 74136, United States

Location

Site Reference ID/Investigator# 4467

Medford, Oregon, 97504, United States

Location

Site Reference ID/Investigator# 4470

Carlisle, Pennsylvania, 17015, United States

Location

Site Reference ID/Investigator# 5581

Downingtown, Pennsylvania, 19335, United States

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Site Reference ID/Investigator# 4434

Feasterville, Pennsylvania, 19053, United States

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Site Reference ID/Investigator# 4478

Harleysville, Pennsylvania, 19438-2513, United States

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Site Reference ID/Investigator# 4436

Jersey Shore, Pennsylvania, 17740, United States

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Site Reference ID/Investigator# 4397

Lansdale, Pennsylvania, 19046, United States

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Site Reference ID/Investigator# 4426

Melrose Park, Pennsylvania, 19027, United States

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Site Reference ID/Investigator# 4894

Newtown, Pennsylvania, 18940, United States

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Site Reference ID/Investigator# 4496

Penndel, Pennsylvania, 19047, United States

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Site Reference ID/Investigator# 4404

Philadelphia, Pennsylvania, 19114, United States

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Site Reference ID/Investigator# 4437

Philadelphia, Pennsylvania, 19115, United States

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Site Reference ID/Investigator# 4387

Philadelphia, Pennsylvania, 19152, United States

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Site Reference ID/Investigator# 4447

Warminster, Pennsylvania, 18974, United States

Location

Site Reference ID/Investigator# 4506

Charleston, South Carolina, 29407, United States

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Site Reference ID/Investigator# 5443

Greenville, South Carolina, 29615, United States

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Site Reference ID/Investigator# 4484

Greer, South Carolina, 29651, United States

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Site Reference ID/Investigator# 4455

Moncks Corner, South Carolina, 29461, United States

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Site Reference ID/Investigator# 4513

Mt. Pleasant, South Carolina, 29464, United States

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Site Reference ID/Investigator# 4521

Simpsonville, South Carolina, 29681, United States

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Site Reference ID/Investigator# 4982

Summerville, South Carolina, 29485, United States

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Site Reference ID/Investigator# 5586

Sioux Falls, South Dakota, 57104, United States

Location

Site Reference ID/Investigator# 4435

Jackson, Tennessee, 38305, United States

Location

Site Reference ID/Investigator# 4454

Johnson City, Tennessee, 37601, United States

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Site Reference ID/Investigator# 4529

Nashville, Tennessee, 37205, United States

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Site Reference ID/Investigator# 5454

Arlington, Texas, 76012, United States

Location

Site Reference ID/Investigator# 5578

Houston, Texas, 77030, United States

Location

Site Reference ID/Investigator# 5669

Houston, Texas, 77030, United States

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Site Reference ID/Investigator# 4893

San Antonio, Texas, 78205, United States

Location

Site Reference ID/Investigator# 4429

San Antonio, Texas, 78215, United States

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Site Reference ID/Investigator# 4457

San Antonio, Texas, 78224, United States

Location

Site Reference ID/Investigator# 4465

San Antonio, Texas, 78229-4801, United States

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Site Reference ID/Investigator# 4508

San Antonio, Texas, 78229, United States

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Site Reference ID/Investigator# 4892

San Antonio, Texas, 78229, United States

Location

Site Reference ID/Investigator# 5948

San Antonio, Texas, 78229, United States

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Site Reference ID/Investigator# 4413

Temple, Texas, 76502, United States

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Site Reference ID/Investigator# 4456

Falls Church, Virginia, 22044, United States

Location

Site Reference ID/Investigator# 4459

Richmond, Virginia, 23226, United States

Location

Site Reference ID/Investigator# 4408

Richmond, Virginia, 23294, United States

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Site Reference ID/Investigator# 4421

Lakewood, Washington, 98499, United States

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Site Reference ID/Investigator# 4468

Madison, Wisconsin, 53719, United States

Location

Related Publications (2)

• 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.

  PMID: 21174145 DERIVED

• 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.

  PMID: 20953684 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia; Dyslipidemias

Interventions

2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid; Rosuvastatin Calcium; fenofibric acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2007
• First Posted: April 20, 2007
• Study Start: April 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: October 3, 2012
• Results First Posted: August 1, 2012

Record last verified: 2012-09

Locations

US (168)