AzTrials
AzTrials

HypercholesterolemiaPhase 3NCT00463606

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

A Phase 3 study testing ABT-335 and rosuvastatin calcium, ABT-335 and rosuvastatin calcium in people with Hypercholesterolemia and Dyslipidemia, run by AstraZeneca at 168 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 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypercholesterolemia, Dyslipidemia
What is being tested?
ABT-335 and rosuvastatin calcium, ABT-335 and rosuvastatin calcium
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
760 participants
Where
168 sitesUnited States
Study dates
Apr 2007to Feb 2008
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

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

168 sites in 1 country.

168 sites in 1 country

United States168 sites

  • Site Reference ID/Investigator# 4427

    Albuquerque, New Mexico, 87108

  • Site Reference ID/Investigator# 4702

    Anaheim, California, 92804

  • Site Reference ID/Investigator# 5533

    Ann Arbor, Michigan, 48106

  • Site Reference ID/Investigator# 6237

    Ann Arbor, Michigan, 48106

  • Site Reference ID/Investigator# 4393

    Arkansas City, Kansas, 67005

  • Site Reference ID/Investigator# 5454

    Arlington, Texas, 76012

  • Site Reference ID/Investigator# 4472

    Arlington Heights, Illinois, 60004

  • Site Reference ID/Investigator# 4473

    Asheville, North Carolina, 28803

  • Site Reference ID/Investigator# 5635

    Auburn, Maine, 04210

  • Site Reference ID/Investigator# 4442

    Aurora, Colorado, 80012

  • Site Reference ID/Investigator# 4527

    Avon, Indiana, 46123

  • Site Reference ID/Investigator# 5070

    Baltimore, Maryland, 21209

  • Site Reference ID/Investigator# 4979

    Billings, Montana, 59101

  • Site Reference ID/Investigator# 5469

    Birmingham, Alabama, 35205

  • Site Reference ID/Investigator# 4428

    Birmingham, Alabama, 35209-6802

  • Site Reference ID/Investigator# 4985

    Birmingham, Alabama, 35235

  • Site Reference ID/Investigator# 5478

    Blue Ridge, Georgia, 30513

  • Site Reference ID/Investigator# 4463

    Bronxville, New York, 10708

  • Site Reference ID/Investigator# 4480

    Brooklyn Center, Minnesota, 55430

  • Site Reference ID/Investigator# 4470

    Carlisle, Pennsylvania, 17015

  • Site Reference ID/Investigator# 4395

    Chandler, Arizona, 85225

  • Site Reference ID/Investigator# 4506

    Charleston, South Carolina, 29407

  • Site Reference ID/Investigator# 4531

    Charlotte, North Carolina, 28209

  • Site Reference ID/Investigator# 4396

    Charlotte, North Carolina, 28277

  • Site Reference ID/Investigator# 5585

    Chicago, Illinois, 60654

  • Site Reference ID/Investigator# 5593

    Chula Vista, California, 91911

  • Site Reference ID/Investigator# 4390

    Cincinnati, Ohio, 45212

  • Site Reference ID/Investigator# 4400

    Cincinnati, Ohio, 45219

  • Site Reference ID/Investigator# 4501

    Cincinnati, Ohio, 45219

  • Site Reference ID/Investigator# 4517

    Cincinnati, Ohio, 45246

  • Site Reference ID/Investigator# 4499

    City of Saint Peters, Missouri, 63376

  • Site Reference ID/Investigator# 4419

    Colorado Springs, Colorado, 80909

  • Site Reference ID/Investigator# 5584

    Columbus, Ohio, 43212

  • Site Reference ID/Investigator# 4503

    Concord, California, 94520

  • Site Reference ID/Investigator# 5444

    Concord, New Hampshire, 03301

  • Site Reference ID/Investigator# 4401

    Coral Gables, Florida, 33134

  • Site Reference ID/Investigator# 4388

    Decatur, Georgia, 30033

  • Site Reference ID/Investigator# 5581

    Downingtown, Pennsylvania, 19335

  • Site Reference ID/Investigator# 4511

    Dunwoody, Georgia, 30338

  • Site Reference ID/Investigator# 4908

    Elizabeth, New Jersey, 07202

  • Site Reference ID/Investigator# 4530

    Encinitas, California, 92024

  • Site Reference ID/Investigator# 4485

    Evansville, Indiana, 47714

  • Site Reference ID/Investigator# 4458

    Fair Oaks, California, 95628

  • Site Reference ID/Investigator# 4456

    Falls Church, Virginia, 22044

  • Site Reference ID/Investigator# 4434

    Feasterville, Pennsylvania, 19053

  • Site Reference ID/Investigator# 4453

    Fort Lauderdale, Florida, 33308

  • Site Reference ID/Investigator# 4542

    Fresno, California, 93703

  • Site Reference ID/Investigator# 4574

    Fresno, California, 93710

  • Site Reference ID/Investigator# 4483

    Gilbert, Arizona, 85295

  • Site Reference ID/Investigator# 5443

    Greenville, South Carolina, 29615

  • Site Reference ID/Investigator# 4484

    Greer, South Carolina, 29651

  • Site Reference ID/Investigator# 4478

    Harleysville, Pennsylvania, 19438-2513

  • Site Reference ID/Investigator# 4412

    Haverhill, Massachusetts, 01830

  • Site Reference ID/Investigator# 5494

    Hickory, North Carolina, 28601

  • Site Reference ID/Investigator# 4490

    Holly Hill, Florida, 32117

  • Site Reference ID/Investigator# 4420

    Hollywood, Florida, 33021

  • Site Reference ID/Investigator# 5578

    Houston, Texas, 77030

  • Site Reference ID/Investigator# 5669

    Houston, Texas, 77030

  • Site Reference ID/Investigator# 4493

    Huntsville, Alabama, 35801

  • Site Reference ID/Investigator# 4510

    Huntsville, Alabama, 35802

  • Site Reference ID/Investigator# 4445

    Indianapolis, Indiana, 46260

  • Site Reference ID/Investigator# 4403

    Iowa City, Iowa, 52242

  • Site Reference ID/Investigator# 4515

    Jackson, Mississippi, 39202

  • Site Reference ID/Investigator# 4435

    Jackson, Tennessee, 38305

  • Site Reference ID/Investigator# 5011

    Jacksonville, Florida, 32216

  • Site Reference ID/Investigator# 4444

    Jacksonville, Florida, 32259

  • Site Reference ID/Investigator# 4436

    Jersey Shore, Pennsylvania, 17740

  • Site Reference ID/Investigator# 4454

    Johnson City, Tennessee, 37601

  • Site Reference ID/Investigator# 4399

    Jupiter, Florida, 33458-7200

  • Site Reference ID/Investigator# 4500

    Kansas City, Missouri, 64114

  • Site Reference ID/Investigator# 4433

    Kissimmee, Florida, 34741

  • Site Reference ID/Investigator# 4438

    Lafayette, Indiana, 47904

  • Site Reference ID/Investigator# 4421

    Lakewood, Washington, 98499

  • Site Reference ID/Investigator# 4397

    Lansdale, Pennsylvania, 19046

  • Site Reference ID/Investigator# 4469

    Largo, Florida, 33773

  • Site Reference ID/Investigator# 4460

    Las Vegas, Nevada, 89102

  • Site Reference ID/Investigator# 4466

    Las Vegas, Nevada, 89123

  • Site Reference ID/Investigator# 5484

    Las Vegas, Nevada, 89146

  • Site Reference ID/Investigator# 5027

    Lexington, Kentucky, 40509

  • Site Reference ID/Investigator# 4441

    Lincoln, California, 95648

  • Site Reference ID/Investigator# 4417

    Little Rock, Arkansas, 72204

  • Site Reference ID/Investigator# 4432

    Long Beach, California, 90806

  • Site Reference ID/Investigator# 5579

    Los Angeles, California, 90057

  • Site Reference ID/Investigator# 4471

    Louisville, Kentucky, 40213

  • Site Reference ID/Investigator# 4468

    Madison, Wisconsin, 53719

  • Site Reference ID/Investigator# 4467

    Medford, Oregon, 97504

  • Site Reference ID/Investigator# 4525

    Melbourne, Florida, 32935

  • Site Reference ID/Investigator# 4426

    Melrose Park, Pennsylvania, 19027

  • Site Reference ID/Investigator# 4477

    Miami, Florida, 33173

  • Site Reference ID/Investigator# 4481

    Missoula, Montana, 59808

  • Site Reference ID/Investigator# 4410

    Mogadore, Ohio, 44260

  • Site Reference ID/Investigator# 4455

    Moncks Corner, South Carolina, 29461

  • Site Reference ID/Investigator# 4479

    Morehead City, North Carolina, 28557

  • Site Reference ID/Investigator# 4513

    Mt. Pleasant, South Carolina, 29464

  • Site Reference ID/Investigator# 4529

    Nashville, Tennessee, 37205

  • Site Reference ID/Investigator# 4406

    New Orleans, Louisiana, 70112

  • Site Reference ID/Investigator# 4430

    New Port Richey, Florida, 34652

  • Site Reference ID/Investigator# 4409

    New Smyrna Beach, Florida, 32168

  • Site Reference ID/Investigator# 4415

    New York, New York, 10021

  • Site Reference ID/Investigator# 5010

    Newburgh, Indiana, 47630

  • Site Reference ID/Investigator# 4894

    Newtown, Pennsylvania, 18940

  • Site Reference ID/Investigator# 4980

    Norwalk, California, 90650

  • Site Reference ID/Investigator# 4416

    Ocala, Florida, 34471

  • Site Reference ID/Investigator# 4528

    Ocala, Florida, 34471

  • Site Reference ID/Investigator# 4488

    Oklahoma City, Oklahoma, 73103

  • Site Reference ID/Investigator# 4451

    Oklahoma City, Oklahoma, 73112

  • Site Reference ID/Investigator# 4492

    Olive Branch, Mississippi, 38654

  • Site Reference ID/Investigator# 5103

    Orlando, Florida, 32806

  • Site Reference ID/Investigator# 4446

    Ormond Beach, Florida, 32174

  • Site Reference ID/Investigator# 4526

    Overland Park, Kansas, 66202

  • Site Reference ID/Investigator# 4431

    Ozark, Alabama, 36360

  • Site Reference ID/Investigator# 4496

    Penndel, Pennsylvania, 19047

  • Site Reference ID/Investigator# 4524

    Pensacola, Florida, 32514

  • Site Reference ID/Investigator# 4520

    Peoria, Illinois, 61602

  • Site Reference ID/Investigator# 4404

    Philadelphia, Pennsylvania, 19114

  • Site Reference ID/Investigator# 4437

    Philadelphia, Pennsylvania, 19115

  • Site Reference ID/Investigator# 4387

    Philadelphia, Pennsylvania, 19152

  • Site Reference ID/Investigator# 5583

    Portage, Michigan, 49024

  • Site Reference ID/Investigator# 4461

    Raleigh, North Carolina, 27609

  • Site Reference ID/Investigator# 4459

    Richmond, Virginia, 23226

  • Site Reference ID/Investigator# 4408

    Richmond, Virginia, 23294

  • Site Reference ID/Investigator# 4440

    Rochester, New York, 14609

  • Site Reference ID/Investigator# 4981

    Roswell, Georgia, 30075

  • Site Reference ID/Investigator# 4448

    Roswell, Georgia, 30076

  • Site Reference ID/Investigator# 4392

    Sacramento, California, 95825

  • Site Reference ID/Investigator# 4896

    Sacramento, California, 95825

  • Site Reference ID/Investigator# 4498

    Salisbury, North Carolina, 28144

  • Site Reference ID/Investigator# 4893

    San Antonio, Texas, 78205

  • Site Reference ID/Investigator# 4429

    San Antonio, Texas, 78215

  • Site Reference ID/Investigator# 4457

    San Antonio, Texas, 78224

  • Site Reference ID/Investigator# 4465

    San Antonio, Texas, 78229-4801

  • Site Reference ID/Investigator# 4508

    San Antonio, Texas, 78229

  • Site Reference ID/Investigator# 4892

    San Antonio, Texas, 78229

  • Site Reference ID/Investigator# 5948

    San Antonio, Texas, 78229

  • Site Reference ID/Investigator# 5582

    San Diego, California, 92128

  • Site Reference ID/Investigator# 4443

    Sandusky, Ohio, 44870

  • Site Reference ID/Investigator# 4505

    Sarasota, Florida, 34233

  • Site Reference ID/Investigator# 5580

    Sarasota, Florida, 34239

  • Site Reference ID/Investigator# 4502

    Scarborough, Maine, 04074

  • Site Reference ID/Investigator# 4411

    Scottsdale, Arizona, 85251

  • Site Reference ID/Investigator# 4521

    Simpsonville, South Carolina, 29681

  • Site Reference ID/Investigator# 5586

    Sioux Falls, South Dakota, 57104

  • Site Reference ID/Investigator# 4509

    Slidell, Louisiana, 70458

  • Site Reference ID/Investigator# 4504

    South Bound Brook, New Jersey, 08880

  • Site Reference ID/Investigator# 4487

    Springfield, Massachusetts, 01103

  • Site Reference ID/Investigator# 4405

    Statesville, North Carolina, 28677

  • Site Reference ID/Investigator# 4982

    Summerville, South Carolina, 29485

  • Site Reference ID/Investigator# 4497

    Suwanee, Georgia, 30024

  • Site Reference ID/Investigator# 4464

    Syracuse, New York, 13202

  • Site Reference ID/Investigator# 4413

    Temple, Texas, 76502

  • Site Reference ID/Investigator# 4394

    Toms River, New Jersey, 08755

  • Site Reference ID/Investigator# 4402

    Trenton, New Jersey, 08611

  • Site Reference ID/Investigator# 4422

    Tulsa, Oklahoma, 74104

  • Site Reference ID/Investigator# 4482

    Tulsa, Oklahoma, 74136

  • Site Reference ID/Investigator# 5636

    Tupelo, Mississippi, 38801

  • Site Reference ID/Investigator# 4519

    Tuscaloosa, Alabama, 35406

  • Site Reference ID/Investigator# 4447

    Warminster, Pennsylvania, 18974

  • Site Reference ID/Investigator# 4523

    Warren, Ohio, 44483

  • Site Reference ID/Investigator# 4391

    Waterbury, Connecticut, 06708

  • Site Reference ID/Investigator# 6236

    West Hills, California, 91307

  • Site Reference ID/Investigator# 4494

    West Palm Beach, Florida, 33401

  • Site Reference ID/Investigator# 4407

    West Palm Beach, Florida, 33407

  • Site Reference ID/Investigator# 4423

    Wichita, Kansas, 67203

  • Site Reference ID/Investigator# 4424

    Wichita, Kansas, 67207

  • Site Reference ID/Investigator# 4425

    Williamsville, New York, 14221

  • Site Reference ID/Investigator# 4476

    Winston-Salem, North Carolina, 27103

  • Site Reference ID/Investigator# 4512

    Winter Haven, Florida, 33880

  • Site Reference ID/Investigator# 4439

    Woodstock, Georgia, 30189

Other trials in United States

About this study

Official title: A 12-week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to ABT-335 and Rosuvastatin Monotherapy in Subjects With Type IIa and IIb Dyslipidemia

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.

Read the detailed description

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).

Being tested
ABT-335 and rosuvastatin calcium, ABT-335, rosuvastatin calcium
Medical subject headings
Hypercholesterolemia, Dyslipidemias

What participants receive

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

  • ABT-335 and rosuvastatin calciumDrug

    Also called ABT-335 / Rosuvastatin Combination (ABT-143)

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

  • ABT-335Drug

    Also called fenofibric acid

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

  • rosuvastatin calciumDrug

    Also called Rosuvastatin

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

Study groups in NCT00463606
Study groupRoleWhat they receive
ABT-335 and Rosuvastatin CalciumExperimentalABT-335 135mg in combination with rosuvastatin calcium 5mg administered orally, once daily for 12 weeks
Receives: Drug: ABT-335 and rosuvastatin calcium
ABT-335Active comparatorABT-335 135mg monotherapy administered orally, once daily for 12 weeks
Receives: Drug: ABT-335
Rosuvastatin CalciumActive comparatorRosuvastatin calcium 5mg monotherapy administered orally, once daily for 12 weeks
Receives: Drug: rosuvastatin calcium

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 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.

    Measured: Baseline to 12 Weeks

  2. 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.

    Measured: Baseline to 12 Weeks

  3. 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.

    Measured: Baseline to 12 Weeks

Secondary outcomes (6)

  1. 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)

    The 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.

    Measured: Baseline to 12 Weeks

  2. 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)

    The 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.

    Measured: Baseline to 12 Weeks

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

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

    Measured: Baseline to 12 Weeks

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

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

    Measured: Baseline to 12 Weeks

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

    The median percent change from baseline to the final visit in high sensitivity C-reactive protein (hsCRP), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.

    Measured: Baseline to 12 Weeks

  6. Mean Percent Change From Baseline to the Final Visit in Total Cholesterol (Full Analysis Set)

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

    Measured: Baseline to 12 Weeks

Timeline

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

  1. First posted20 Apr 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionFeb 2008
  4. Study completionFeb 2008

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
Double blind
Who is masked
Participant, Investigator
Enrolment
760 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00463606
Sponsor's protocol ID
M06-844
Status last verified
Sep 2012
First submitted
19 Apr 2007
Last updated
3 Oct 2012
Data monitoring committee
No

Publications

  • 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.

    PubMed 21174145

  • 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.

    PubMed 20953684

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABT-335 and rosuvastatin calcium, ABT-335 and rosuvastatin calcium in people with Hypercholesterolemia and Dyslipidemia, run by AstraZeneca at 168 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 6 inclusion and 2 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 168 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 High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set) (time frame: Baseline to 12 Weeks). The study lists 3 primary outcomes in all. 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 NCT00463606, which also lists 2 linked publications.

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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