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DyslipidemiaPhase 3NCT00680017

30 Week Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy for Subjects With Dyslipidemia and Stage 3 Chronic Kidney Disease

A Phase 3 study testing ABT-335 plus rosuvastatin and Rosuvastatin in people with Dyslipidemia and Kidney Disease, run by AstraZeneca at 114 sites in 2 countries.

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 objective of this study is to evaluate the safety and efficacy of the combination of ABT-335 plus rosuvastatin in dyslipidemic subjects with Chronic Kidney Disease (CKD) Stage 3. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dyslipidemia, Kidney Disease
What is being tested?
ABT-335 plus rosuvastatin and Rosuvastatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
114 sitesin 2 countries
Study dates
Jun 2008to Apr 2011
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

  • Dyslipidemic participants with Chronic Kidney Disease Stage 3
  • For entry into the Treatment Phase (Visit 3), the participant satisfied the following laboratory criteria (measured at the Screening Visit[s]):
  • Estimated glomerular filtration rate between 30 and 59 mL/min/1.73 m2 (Chronic Kidney Disease Stage 3) by simplified 4 variable Modification of Diet in Renal Disease formula (this includes a 10 percent variation in the upper limit of estimated glomerular filtration rate that was allowed for the enrollment of participants to account for variability in the creatinine assay).
  • Fasting lipid results following greater than or equal to 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
Show all 12Show fewer
  • Low-density lipoprotein cholesterol greater than or equal to 130 mg/dL Exclusion Criteria
  • Participants with certain chronic or unstable medical conditions.
  • Participants with unstable dose of medications or receiving coumarin anticoagulants, systemic cyclosporine, or certain other medications.
  • Pregnant or lactating women, or women intending to become pregnant.
  • Participants with diabetes mellitus that is poorly controlled.
  • Participants of Asian ancestry (having Filipino, Chinese, Japanese, Korean, Vietnamese, or Asian-Indian origin).

Who cannot join

None listed.

Trial locations and contacts

114 sites in 2 countries.

114 sites in 2 countries

United States102 sites

  • Site Reference ID/Investigator# 7958

    Arvada, Colorado, 80002

  • Site Reference ID/Investigator# 8136

    Atlanta, Georgia, 30331

  • Site Reference ID/Investigator# 21805

    Auburn, Maine, 04210

  • Site Reference ID/Investigator# 38405

    Baton Rouge, Louisiana, 70809

  • Site Reference ID/Investigator# 8345

    Bend, Oregon, 97701

  • Site Reference ID/Investigator# 22703

    Berlin, New Jersey, 08009

  • Site Reference ID/Investigator# 8411

    Bethlehem, Pennsylvania, 18017

  • Site Reference ID/Investigator# 22521

    Birmingham, Alabama, 35242

  • Site Reference ID/Investigator# 23224

    Boynton Beach, Florida, 33472

  • Site Reference ID/Investigator# 22222

    Brooklyn Center, Minnesota, 55430

  • Site Reference ID/Investigator# 8405

    Carlisle, Pennsylvania, 17015

  • Site Reference ID/Investigator# 22823

    Charleston, South Carolina, 29412

  • Site Reference ID/Investigator# 22481

    Charlotte, North Carolina, 28262

  • Site Reference ID/Investigator# 22708

    Charlotte, North Carolina, 28277

  • Site Reference ID/Investigator# 27682

    Chicago, Illinois, 60616

  • Site Reference ID/Investigator# 7869

    Chula Vista, California, 91910

  • Site Reference ID/Investigator# 8417

    Cincinnati, Ohio, 45267-0585

  • Site Reference ID/Investigator# 22474

    Clearwater, Florida, 33756

  • Site Reference ID/Investigator# 8364

    Columbia, South Carolina, 29206

  • Site Reference ID/Investigator# 8147

    Columbus, Ohio, 43215

  • Site Reference ID/Investigator# 21803

    Coral Springs, Florida, 33065

  • Site Reference ID/Investigator# 8094

    Council Bluffs, Iowa, 51501

  • Site Reference ID/Investigator# 22812

    Dallas, Texas, 75251

  • Site Reference ID/Investigator# 22811

    Daytona Beach, Florida, 32117

  • Site Reference ID/Investigator# 15881

    Denver, Colorado, 80230

  • Site Reference ID/Investigator# 22387

    Duncansville, Pennsylvania, 16635

  • Site Reference ID/Investigator# 23503

    Dunwoody, Georgia, 30338

  • Site Reference ID/Investigator# 8536

    Edinburg, Texas, 78539

  • Site Reference ID/Investigator# 22707

    Elizabeth, New Jersey, 07202

  • Site Reference ID/Investigator# 8225

    Fall River, Massachusetts, 02720

  • Site Reference ID/Investigator# 8387

    Flushing, New York, 11355

  • Site Reference ID/Investigator# 22810

    Fort Worth, Texas, 76104

  • Site Reference ID/Investigator# 8435

    Fountain Valley, California, 92708

  • Site Reference ID/Investigator# 8413

    Gig Harbor, Washington, 98335

  • Site Reference ID/Investigator# 8177

    Great Neck, New York, 11021

  • Site Reference ID/Investigator# 22429

    Greenville, South Carolina, 29605

  • Site Reference ID/Investigator# 22702

    Hillsborough, New Jersey, 08844

  • Site Reference ID/Investigator# 27103

    Hollywood, Florida, 33021

  • Site Reference ID/Investigator# 24742

    Houston, Texas, 77005

  • Site Reference ID/Investigator# 26722

    Houston, Texas, 77024

  • Site Reference ID/Investigator# 8406

    Houston, Texas, 77099

  • Site Reference ID/Investigator# 8398

    Hudson, Florida, 34667

  • Site Reference ID/Investigator# 22478

    Huntsville, Alabama, 35801

  • Site Reference ID/Investigator# 22430

    Iowa City, Iowa, 52242

  • Site Reference ID/Investigator# 22815

    Jersey Shore, Pennsylvania, 17740

  • Site Reference ID/Investigator# 12881

    Johnstown, Pennsylvania, 15905

  • Site Reference ID/Investigator# 26723

    Kissimmee, Florida, 34741

  • Site Reference ID/Investigator# 37676

    Kissimmee, Florida, 34759

  • Site Reference ID/Investigator# 8146

    Lake Success, New York, 11042

  • Site Reference ID/Investigator# 8231

    Lauderdale Lakes, Florida, 33313

  • Site Reference ID/Investigator# 22487

    Lincoln, California, 95648

  • Site Reference ID/Investigator# 22426

    Long Beach, California, 90806

  • Site Reference ID/Investigator# 22486

    Longwood, Florida, 32779

  • Site Reference ID/Investigator# 8096

    Los Angeles, California, 90048

  • Site Reference ID/Investigator# 8232

    Lubbock, Texas, 79410

  • Site Reference ID/Investigator# 7948

    Macon, Georgia, 31217

  • Site Reference ID/Investigator# 8365

    Madison, Alabama, 35758

  • Site Reference ID/Investigator# 22488

    Mason, Ohio, 45040

  • Site Reference ID/Investigator# 22704

    Medford, Oregon, 97504

  • Site Reference ID/Investigator# 13922

    Mishawaka, Indiana, 46545-3519

  • Site Reference ID/Investigator# 8416

    Montgomery, Alabama, 36106-1111

  • Site Reference ID/Investigator# 8434

    Morehead City, North Carolina, 28557

  • Site Reference ID/Investigator# 22428

    Mt. Pleasant, South Carolina, 29464

  • Site Reference ID/Investigator# 22520

    New Port Richey, Florida, 34652

  • Site Reference ID/Investigator# 22962

    Norwalk, California, 90650

  • Site Reference ID/Investigator# 21804

    Ogden, Utah, 84403

  • Site Reference ID/Investigator# 22479

    Oklahoma City, Oklahoma, 73103

  • Site Reference ID/Investigator# 23225

    Oklahoma City, Oklahoma, 73112

  • Site Reference ID/Investigator# 8408

    Olive Branch, Mississippi, 38654

  • Site Reference ID/Investigator# 8226

    Orlando, Florida, 32804

  • Site Reference ID/Investigator# 22477

    Ormond Beach, Florida, 32174

  • Site Reference ID/Investigator# 8093

    Paducah, Kentucky, 42003

  • Site Reference ID/Investigator# 8386

    Pembroke Pines, Florida, 33028

  • Site Reference ID/Investigator# 8227

    Peoria, Illinois, 61603

  • Site Reference ID/Investigator# 22706

    Perkasie, Pennsylvania, 18944

  • Site Reference ID/Investigator# 8095

    Philadelphia, Pennsylvania, 19107

  • Site Reference ID/Investigator# 22518

    Plant City, Florida, 33563

  • Site Reference ID/Investigator# 12882

    Port Charlotte, Florida, 33952

  • Site Reference ID/Investigator# 8400

    Portland, Oregon, 97210

  • Site Reference ID/Investigator# 8098

    Providence, Rhode Island, 02904

  • Site Reference ID/Investigator# 8311

    Riverside, California, 92505

  • Site Reference ID/Investigator# 8092

    Rockville, Maryland, 20852

  • Site Reference ID/Investigator# 22819

    Roswell, Georgia, 30076

  • Site Reference ID/Investigator# 8415

    Royal Oak, Michigan, 48073

  • Site Reference ID/Investigator# 22816

    Sacramento, California, 95825

  • Site Reference ID/Investigator# 37675

    Saint Cloud, Florida, 34769

  • Site Reference ID/Investigator# 22423

    Salt Lake City, Utah, 84124

  • Site Reference ID/Investigator# 22480

    San Antonio, Texas, 78224

  • Site Reference ID/Investigator# 8397

    San Antonio, Texas, 78229

  • Site Reference ID/Investigator# 8903

    Shreveport, Louisiana, 71101

  • Site Reference ID/Investigator# 8510

    Simi Valley, California, 93065

  • Site Reference ID/Investigator# 8407

    Springfield, Massachusetts, 01107

  • Site Reference ID/Investigator# 25302

    Summerville, South Carolina, 29485

  • Site Reference ID/Investigator# 22813

    Suwanee, Georgia, 30024

  • Site Reference ID/Investigator# 22705

    Tipton, Pennsylvania, 16684

  • Site Reference ID/Investigator# 22482

    Tulsa, Oklahoma, 74136

  • Site Reference ID/Investigator# 22817

    Warminster, Pennsylvania, 18974

  • Site Reference ID/Investigator# 22821

    West Hills, California, 91307

  • Site Reference ID/Investigator# 8410

    West Palm Beach, Florida, 33401

  • Site Reference ID/Investigator# 8399

    Westminster, Colorado, 80031

  • Site Reference ID/Investigator# 22427

    Williamsville, New York, 14221

  • Site Reference ID/Investigator# 21802

    Winter Haven, Florida, 33880

Other trials in United States

Puerto Rico12 sites

  • Site Reference ID/Investigator# 24402

    Carolina, 00983

  • Site Reference ID/Investigator# 22545

    Humacao, 00791

  • Site Reference ID/Investigator# 8301

    Manati, 00674

  • Site Reference ID/Investigator# 8299

    Ponce, 00717-0634

  • Site Reference ID/Investigator# 8418

    Ponce, 00717-1322

  • Site Reference ID/Investigator# 8419

    Ponce, 00717-2075

  • Site Reference ID/Investigator# 8421

    San Juan, 00907

  • Site Reference ID/Investigator# 8300

    San Juan, 00909

  • Site Reference ID/Investigator# 8422

    San Juan, 00918

  • Site Reference ID/Investigator# 8423

    San Juan, 00936-5067

  • Site Reference ID/Investigator# 8420

    Toa Baja, 00949

  • Site Reference ID/Investigator# 8298

    Yabucoa, 00767

Other trials in Puerto Rico

About this study

Official title: A 30-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy in Dyslipidemic Subjects With Stage 3 Chronic Kidney Disease

The objective of this study is to evaluate the safety and efficacy of the combination of ABT-335 plus rosuvastatin in dyslipidemic subjects with Chronic Kidney Disease (CKD) Stage 3.

Being tested
ABT-335 plus rosuvastatin, Rosuvastatin
Keywords
Dyslipidemia, Kidney Disease
Medical subject headings
Dyslipidemias, Kidney Diseases

What participants receive

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

  • ABT-335 plus rosuvastatinDrug

    Also called fenofibric acid and rosuvastatin

    ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks

  • RosuvastatinDrug

    Also called rosuvastatin, Crestor

    Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks

Study groups in NCT00680017
Study groupRoleWhat they receive
ABT-335 plus rosuvastatinExperimentalABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
Receives: Drug: ABT-335 plus rosuvastatin
RosuvastatinActive comparatorRosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
Receives: Drug: Rosuvastatin

What is being measured

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

  1. Median Percent Change in Triglycerides From Baseline to Week 8.

    Triglycerides were measured in milligrams/deciliter.

    Measured: Baseline to 8 weeks

Secondary outcomes (1)

  1. Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8.

    High-density lipoprotein cholesterol (HDL-C) was measured in milligrams/deciliter (mg/dL).

    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 posted19 May 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionApr 2011
  4. Study completionApr 2011

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00680017
Sponsor's protocol ID
M10-313
Status last verified
Sep 2012
First submitted
15 May 2008
Last updated
3 Oct 2012

Publications

  • Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.

    PubMed 38018702

  • Weinstein DL, Williams LA, Carlson DM, Kelly MT, Burns KM, Setze CM, Lele A, Stolzenbach JC. A randomized, double-blind study of fenofibric acid plus rosuvastatin compared with rosuvastatin alone in stage 3 chronic kidney disease. Clin Ther. 2013 Aug;35(8):1186-98. doi: 10.1016/j.clinthera.2013.06.013. Epub 2013 Jul 26.

    PubMed 23891363

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABT-335 plus rosuvastatin and Rosuvastatin in people with Dyslipidemia and Kidney Disease, run by AstraZeneca at 114 sites in 2 countries.

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 12 inclusion and 0 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 114 sites in United States, Puerto Rico. 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 16 Jul 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?

Median Percent Change in Triglycerides From Baseline to Week 8. (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 NCT00680017, 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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